| Primary | Cumulative Ongoing Pregnancy Rate After the Fresh Cycle and Cryopreserved Cycles Initiated Within 12 Months From the Start of Controlled Ovarian Stimulation (COS) | Defined as at least one intrauterine viable fetus 8-9 weeks after transfer. Data in this endpoint are presented for the fresh cycle and the cryopreserved cycles. | The mITT analysis set comprised all randomized and exposed participants. Participants were analyzed according to planned treatment. | Posted | | Number | | percentage of participants | | 8-9 weeks after transfer (up to approximately 16 months after start of stimulation) | | | | ID | Title | Description |
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| OG000 | FE 999049 (Follitropin Delta) | FE 999049 was administered as single daily subcutaneous injections in the abdomen at a starting dose of 15 μg daily that was fixed for the first four stimulation days. Based on ovarian response, the dose could be adjusted by 3 μg, with dose increases implemented not more frequently than once every 2 days and dose decreases implemented per investigator's judgement. The minimum daily dose was 6 μg, and the maximum daily dose was 24 μg. Participants could be treated for a maximum of 20 days. Coasting, use of dopamine agonist or any other drug to prevent early ovarian hyperstimulation syndrome (OHSS) with the exception of gonadotropin-releasing hormone (GnRH) agonist for triggering of final follicular maturation, was not allowed. | | OG001 | Placebo | Placebo was administered as single daily subcutaneous injection dialed to the same value (dose) as FE 999049. Participants could be treated for a maximum of 20 days. Coasting, use of dopamine agonist or any other drug to prevent early OHSS with the exception of GnRH agonist for triggering of final follicular maturation, was not allowed. |
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| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
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| | Fisher Exact | | <0.001 | | Treatment difference | 43.3 | | | 2-Sided | 95 | 36.5 | 47.6 | | | 95% exact Agresti-Min confidence intervals. | | Other | | |
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| Secondary | Ongoing Pregnancy Rate in the Fresh Cycle and in the Cryopreserved Cycles | Defined as at least one intrauterine viable fetus 8-9 weeks after transfer. Data in this endpoint are presented for the fresh cycle and the cryopreserved cycles. | The mITT analysis set comprised all randomized and exposed participants. Participants were analyzed according to planned treatment. | Posted | | Number | | percentage of participants | | 8-9 weeks after transfer (up to approximately 16 months after start of stimulation) | | | | ID | Title | Description |
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| OG000 | FE 999049 (Follitropin Delta) | FE 999049 was administered as single daily subcutaneous injections in the abdomen at a starting dose of 15 μg daily that was fixed for the first four stimulation days. Based on ovarian response, the dose could be adjusted by 3 μg, with dose increases implemented not more frequently than once every 2 days and dose decreases implemented per investigator's judgement. The minimum daily dose was 6 μg, and the maximum daily dose was 24 μg. Participants could be treated for a maximum of 20 days. Coasting, use of dopamine agonist or any other drug to prevent early OHSS with the exception of GnRH agonist for triggering of final follicular maturation, was not allowed. | | OG001 | Placebo | Placebo was administered as single daily subcutaneous injection dialed to the same value (dose) as FE 999049. Participants could be treated for a maximum of 20 days. Coasting, use of dopamine agonist or any other drug to prevent early OHSS with the exception of GnRH agonist for triggering of final follicular maturation, was not allowed. |
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| Secondary | Time From Start of COS to Ongoing Pregnancy Across the Fresh and Cryopreserved Cycles, Including Duration | Time from start of COS to ongoing pregnancy, including both the fresh and cryopreserved cycles. In the placebo group, no participants achieved an ongoing pregnancy either after 12 calendar months or after 12 study months. | The mITT analysis set comprised all randomized and exposed participants. Participants were analyzed according to planned treatment. | Posted | | Mean | Standard Deviation | days | | 8-9 weeks after transfer (up to approximately 16 months after start of stimulation) | | | | ID | Title | Description |
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| OG000 | FE 999049 (Follitropin Delta) | FE 999049 was administered as single daily subcutaneous injections in the abdomen at a starting dose of 15 μg daily that was fixed for the first four stimulation days. Based on ovarian response, the dose could be adjusted by 3 μg, with dose increases implemented not more frequently than once every 2 days and dose decreases implemented per investigator's judgement. The minimum daily dose was 6 μg, and the maximum daily dose was 24 μg. Participants could be treated for a maximum of 20 days. Coasting, use of dopamine agonist or any other drug to prevent early OHSS with the exception of GnRH agonist for triggering of final follicular maturation, was not allowed. |
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| Secondary | Time From Start of COS to Ongoing Pregnancy Across the Fresh and Cryopreserved Cycles, Measured in Number of Cycles Before Achieving Ongoing Pregnancy | Time from start of COS to ongoing pregnancy, including both the fresh and cryopreserved cycles, measured in number of cycles before achieving ongoing pregnancy. In the placebo group, no participants achieved an ongoing pregnancy either after 12 calendar months or after 12 study months. | The mITT analysis set comprised all randomized and exposed participants. Participants were analyzed according to planned treatment. | Posted | | Mean | Standard Deviation | Cycles | | 8-9 weeks after transfer (up to approximately 16 months after start of stimulation) | | | | ID | Title | Description |
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| OG000 | FE 999049 (Follitropin Delta) | FE 999049 was administered as single daily subcutaneous injections in the abdomen at a starting dose of 15 μg daily that was fixed for the first four stimulation days. Based on ovarian response, the dose could be adjusted by 3 μg, with dose increases implemented not more frequently than once every 2 days and dose decreases implemented per investigator's judgement. The minimum daily dose was 6 μg, and the maximum daily dose was 24 μg. Participants could be treated for a maximum of 20 days. Coasting, use of dopamine agonist or any other drug to prevent early OHSS with the exception of GnRH agonist for triggering of final follicular maturation, was not allowed. |
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| Secondary | Ongoing Implantation Rate in the Fresh Cycle, the Cryopreserved Cycles and Cumulatively | Defined as the number of intrauterine viable fetuses 8-9 weeks after transfer divided by number of blastocysts transferred. Data in this endpoint are presented for the fresh cycle, the cryopreserved cycles, and all cycles. One participant can contribute with a range from zero to multiple blastocysts. Data is not shown for placebo arm because no subjects underwent blastocyst transfer in the fresh cycle or cryopreserved cycles. '%' in the unit of measure refers to 'percentage'. | The mITT analysis set comprised all randomized and exposed participants. Participants were analyzed according to planned treatment. | Posted | | Number | | % of viable fetus/blastocyst transfer | | 8-9 weeks after transfer (up to approximately 16 months after start of stimulation) | Blastocysts | Blastocysts | | ID | Title | Description |
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| OG000 | FE 999049 (Follitropin Delta) | FE 999049 was administered as single daily subcutaneous injections in the abdomen at a starting dose of 15 μg daily that was fixed for the first four stimulation days. Based on ovarian response, the dose could be adjusted by 3 μg, with dose increases implemented not more frequently than once every 2 days and dose decreases implemented per investigator's judgement. The minimum daily dose was 6 μg, and the maximum daily dose was 24 μg. Participants could be treated for a maximum of 20 days. Coasting, use of dopamine agonist or any other drug to prevent early OHSS with the exception of GnRH agonist for triggering of final follicular maturation, was not allowed. |
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| Secondary | Clinical Pregnancy Rate in the Fresh Cycle, the Cryopreserved Cycles and Cumulatively | Defined at least one gestational sac 5-6 weeks after transfer. Data in this endpoint are presented for the fresh cycle, the cryopreserved cycles, and all cycles. | The mITT analysis set comprised all randomized and exposed participants. Participants were analyzed according to planned treatment. | Posted | | Number | | percentage of participants | | 5-6 weeks after transfer (up to approximately 15 months after start of stimulation) | | | | ID | Title | Description |
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| OG000 | FE 999049 (Follitropin Delta) | FE 999049 was administered as single daily subcutaneous injections in the abdomen at a starting dose of 15 μg daily that was fixed for the first four stimulation days. Based on ovarian response, the dose could be adjusted by 3 μg, with dose increases implemented not more frequently than once every 2 days and dose decreases implemented per investigator's judgement. The minimum daily dose was 6 μg, and the maximum daily dose was 24 μg. Participants could be treated for a maximum of 20 days. Coasting, use of dopamine agonist or any other drug to prevent early OHSS with the exception of GnRH agonist for triggering of final follicular maturation, was not allowed. | | OG001 | Placebo | Placebo was administered as single daily subcutaneous injection dialed to the same value (dose) as FE 999049. Participants could be treated for a maximum of 20 days. Coasting, use of dopamine agonist or any other drug to prevent early OHSS with the exception of GnRH agonist for triggering of final follicular maturation, was not allowed. |
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| Secondary | Vital Pregnancy Rate in the Fresh Cycle, the Cryopreserved Cycles and Cumulatively | Defined at least one intrauterine gestational sac with fetal heart beat 5-6 weeks after transfer. Data in this endpoint are presented for the fresh cycle, the cryopreserved cycles, and all cycles. | The mITT analysis set comprised all randomized and exposed participants. Participants were analyzed according to planned treatment. | Posted | | Number | | percentage of participants | | 5-6 weeks after transfer (up to approximately 15 months after start of stimulation) | | | | ID | Title | Description |
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| OG000 | FE 999049 (Follitropin Delta) | FE 999049 was administered as single daily subcutaneous injections in the abdomen at a starting dose of 15 μg daily that was fixed for the first four stimulation days. Based on ovarian response, the dose could be adjusted by 3 μg, with dose increases implemented not more frequently than once every 2 days and dose decreases implemented per investigator's judgement. The minimum daily dose was 6 μg, and the maximum daily dose was 24 μg. Participants could be treated for a maximum of 20 days. Coasting, use of dopamine agonist or any other drug to prevent early OHSS with the exception of GnRH agonist for triggering of final follicular maturation, was not allowed. | | OG001 | Placebo | Placebo was administered as single daily subcutaneous injection dialed to the same value (dose) as FE 999049. Participants could be treated for a maximum of 20 days. Coasting, use of dopamine agonist or any other drug to prevent early OHSS with the exception of GnRH agonist for triggering of final follicular maturation, was not allowed. |
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| Secondary | Implantation Rate in the Fresh Cycle, the Cryopreserved Cycles and Cumulatively | Defined as the number of gestational sacs 5-6 weeks after transfer divided by number of blastocysts transferred. The endpoint are presented for the fresh cycle, the cryopreserved cycles, and all cycles. One participant can contribute with a range from zero to multiple blastocysts. Data is not shown for placebo arm because no subjects underwent blastocyst transfer in the fresh cycle or cryopreserved cycles. '%' in the unit of measure refers to 'percentage'. | The mITT analysis set comprised all randomized and exposed participants. Participants were analyzed according to planned treatment. | Posted | | Number | | % gestational sacs/blastocyst transfer | | 5-6 weeks after transfer (up to approximately 15 months after start of stimulation) | Blastocysts | Blastocysts | | ID | Title | Description |
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| OG000 | FE 999049 (Follitropin Delta) | FE 999049 was administered as single daily subcutaneous injections in the abdomen at a starting dose of 15 μg daily that was fixed for the first four stimulation days. Based on ovarian response, the dose could be adjusted by 3 μg, with dose increases implemented not more frequently than once every 2 days and dose decreases implemented per investigator's judgement. The minimum daily dose was 6 μg, and the maximum daily dose was 24 μg. Participants could be treated for a maximum of 20 days. Coasting, use of dopamine agonist or any other drug to prevent early OHSS with the exception of GnRH agonist for triggering of final follicular maturation, was not allowed. |
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| Secondary | Positive Beta Human Chorionic Gonadotropin (βhCG) Rate in the Fresh Cycle, the Cryopreserved Cycles and Cumulatively | Defined as positive serum βhCG test 10-14 days after transfer. Data in this endpoint are presented for the fresh cycle, the cryopreserved cycles, and all cycles. | The mITT analysis set comprised all randomized and exposed participants. Participants were analyzed according to planned treatment. | Posted | | Number | | percentage of participants | | 10-14 days after transfer (up to approximately 14 months after start of stimulation) | | | | ID | Title | Description |
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| OG000 | FE 999049 (Follitropin Delta) | FE 999049 was administered as single daily subcutaneous injections in the abdomen at a starting dose of 15 μg daily that was fixed for the first four stimulation days. Based on ovarian response, the dose could be adjusted by 3 μg, with dose increases implemented not more frequently than once every 2 days and dose decreases implemented per investigator's judgement. The minimum daily dose was 6 μg, and the maximum daily dose was 24 μg. Participants could be treated for a maximum of 20 days. Coasting, use of dopamine agonist or any other drug to prevent early OHSS with the exception of GnRH agonist for triggering of final follicular maturation, was not allowed. | | OG001 | Placebo | Placebo was administered as single daily subcutaneous injection dialed to the same value (dose) as FE 999049. Participants could be treated for a maximum of 20 days. Coasting, use of dopamine agonist or any other drug to prevent early OHSS with the exception of GnRH agonist for triggering of final follicular maturation, was not allowed. |
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| Secondary | Proportion of Subjects in the Fresh Cycle With Triggering of Final Follicular Maturation (With hCG, With GnRH Agonist, and in Total), Cycle Cancellation and Transfer Cancellation | Data in this endpoint are presented for the fresh cycle. | The mITT analysis set comprised all randomized and exposed participants. Participants were analyzed according to planned treatment. | Posted | | Number | | percentage of participants | | Up to 5 days after oocyte retrieval (up to 27 days after start of stimulation) | | | | ID | Title | Description |
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| OG000 | FE 999049 (Follitropin Delta) | FE 999049 was administered as single daily subcutaneous injections in the abdomen at a starting dose of 15 μg daily that was fixed for the first four stimulation days. Based on ovarian response, the dose could be adjusted by 3 μg, with dose increases implemented not more frequently than once every 2 days and dose decreases implemented per investigator's judgement. The minimum daily dose was 6 μg, and the maximum daily dose was 24 μg. Transfer cancellation is mandatory in participants undergoing triggering with GnRH agonist and participants with >=20 oocytes retrieved. Participants could be treated for a maximum of 20 days. Coasting, use of dopamine agonist or any other drug to prevent early OHSS with the exception of GnRH agonist for triggering of final follicular maturation, was not allowed. | | OG001 | Placebo | Placebo was administered as single daily subcutaneous injection dialed to the same value (dose) as FE 999049. Participants could be treated for a maximum of 20 days. Coasting, use of dopamine agonist or any other drug to prevent early OHSS with the exception of GnRH agonist for triggering of final follicular maturation, was not allowed. |
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| Secondary | Number of Follicles on Stimulation Day 5 | The total number of follicles and the number of follicles per size category are reported. | The mITT analysis set comprised all randomized and exposed participants. Participants were analyzed according to planned treatment. | Posted | | Mean | Standard Deviation | number of follicles | | On stimulation day 5 | | | | ID | Title | Description |
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| OG000 | FE 999049 (Follitropin Delta) | FE 999049 was administered as single daily subcutaneous injections in the abdomen at a starting dose of 15 μg daily that was fixed for the first four stimulation days. Based on ovarian response, the dose could be adjusted by 3 μg, with dose increases implemented not more frequently than once every 2 days and dose decreases implemented per investigator's judgement. The minimum daily dose was 6 μg, and the maximum daily dose was 24 μg. Participants could be treated for a maximum of 20 days. Coasting, use of dopamine agonist or any other drug to prevent early OHSS with the exception of GnRH agonist for triggering of final follicular maturation, was not allowed. | | OG001 | Placebo | Placebo was administered as single daily subcutaneous injection dialed to the same value (dose) as FE 999049. Participants could be treated for a maximum of 20 days. Coasting, use of dopamine agonist or any other drug to prevent early OHSS with the exception of GnRH agonist for triggering of final follicular maturation, was not allowed. |
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| Secondary | Number of Follicles at End-of-stimulation | The total number of follicles and the number of follicles per size category are reported. | The mITT analysis set comprised all randomized and exposed participants. Participants were analyzed according to planned treatment. | Posted | | Mean | Standard Deviation | number of follicles | | At end-of-stimulation (up to 20 stimulation days) | | | | ID | Title | Description |
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| OG000 | FE 999049 (Follitropin Delta) | FE 999049 was administered as single daily subcutaneous injections in the abdomen at a starting dose of 15 μg daily that was fixed for the first four stimulation days. Based on ovarian response, the dose could be adjusted by 3 μg, with dose increases implemented not more frequently than once every 2 days and dose decreases implemented per investigator's judgement. The minimum daily dose was 6 μg, and the maximum daily dose was 24 μg. Participants could be treated for a maximum of 20 days. Coasting, use of dopamine agonist or any other drug to prevent early OHSS with the exception of GnRH agonist for triggering of final follicular maturation, was not allowed. | | OG001 | Placebo | Placebo was administered as single daily subcutaneous injection dialed to the same value (dose) as FE 999049. Participants could be treated for a maximum of 20 days. Coasting, use of dopamine agonist or any other drug to prevent early OHSS with the exception of GnRH agonist for triggering of final follicular maturation, was not allowed. |
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| Secondary | Size of Follicles on Stimulation Day 5 | Counted by ultrasound for the right and left ovary for each participant. | The mITT analysis set comprised all randomized and exposed participants. Participants were analyzed according to planned treatment. | Posted | | Mean | Standard Deviation | mm | | On stimulation day 5 | | | | ID | Title | Description |
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| OG000 | FE 999049 (Follitropin Delta) | FE 999049 was administered as single daily subcutaneous injections in the abdomen at a starting dose of 15 μg daily that was fixed for the first four stimulation days. Based on ovarian response, the dose could be adjusted by 3 μg, with dose increases implemented not more frequently than once every 2 days and dose decreases implemented per investigator's judgement. The minimum daily dose was 6 μg, and the maximum daily dose was 24 μg. Participants could be treated for a maximum of 20 days. Coasting, use of dopamine agonist or any other drug to prevent early OHSS with the exception of GnRH agonist for triggering of final follicular maturation, was not allowed. | | OG001 | Placebo | Placebo was administered as single daily subcutaneous injection dialed to the same value (dose) as FE 999049. Participants could be treated for a maximum of 20 days. Coasting, use of dopamine agonist or any other drug to prevent early OHSS with the exception of GnRH agonist for triggering of final follicular maturation, was not allowed. |
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| Secondary | Size of Follicles at End-of-stimulation | Counted by ultrasound for the right and left ovary for each participant. | The mITT analysis set comprised all randomized and exposed participants. Participants were analyzed according to planned treatment. | Posted | | Mean | Standard Deviation | mm | | At end-of-stimulation (up to 20 stimulation days) | | | | ID | Title | Description |
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| OG000 | FE 999049 (Follitropin Delta) | FE 999049 was administered as single daily subcutaneous injections in the abdomen at a starting dose of 15 μg daily that was fixed for the first four stimulation days. Based on ovarian response, the dose could be adjusted by 3 μg, with dose increases implemented not more frequently than once every 2 days and dose decreases implemented per investigator's judgement. The minimum daily dose was 6 μg, and the maximum daily dose was 24 μg. Participants could be treated for a maximum of 20 days. Coasting, use of dopamine agonist or any other drug to prevent early OHSS with the exception of GnRH agonist for triggering of final follicular maturation, was not allowed. | | OG001 | Placebo | Placebo was administered as single daily subcutaneous injection dialed to the same value (dose) as FE 999049. Participants could be treated for a maximum of 20 days. Coasting, use of dopamine agonist or any other drug to prevent early OHSS with the exception of GnRH agonist for triggering of final follicular maturation, was not allowed. |
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| Secondary | Number of Oocytes Retrieved | The number of oocytes retrieved was recorded at the oocyte retrieval visit. | The mITT analysis set comprised all randomized and exposed participants. Participants were analyzed according to planned treatment. | Posted | | Mean | Standard Deviation | number of oocytes retrieved | | On day of oocyte retrieval (up to 22 days after start of stimulation) | | | | ID | Title | Description |
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| OG000 | FE 999049 (Follitropin Delta) | FE 999049 was administered as single daily subcutaneous injections in the abdomen at a starting dose of 15 μg daily that was fixed for the first four stimulation days. Based on ovarian response, the dose could be adjusted by 3 μg, with dose increases implemented not more frequently than once every 2 days and dose decreases implemented per investigator's judgement. The minimum daily dose was 6 μg, and the maximum daily dose was 24 μg. Participants could be treated for a maximum of 20 days. Coasting, use of dopamine agonist or any other drug to prevent early OHSS with the exception of GnRH agonist for triggering of final follicular maturation, was not allowed. | | OG001 | Placebo | Placebo was administered as single daily subcutaneous injection dialed to the same value (dose) as FE 999049. Participants could be treated for a maximum of 20 days. Coasting, use of dopamine agonist or any other drug to prevent early OHSS with the exception of GnRH agonist for triggering of final follicular maturation, was not allowed. |
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| Secondary | Proportion of Subjects With <4, 4-7, 8-14, 15-19 and ≥20 Oocytes Retrieved | Grouped according to the number of oocytes retrieved. Participants with cycle cancellation due to poor ovarian response are included in the <4 oocytes group. | The mITT analysis set comprised all randomized and exposed participants. Participants were analyzed according to planned treatment. | Posted | | Number | | percentage of participants | | On day of oocyte retrieval (up to 22 days after start of stimulation) | | | | ID | Title | Description |
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| OG000 | FE 999049 (Follitropin Delta) | FE 999049 was administered as single daily subcutaneous injections in the abdomen at a starting dose of 15 μg daily that was fixed for the first four stimulation days. Based on ovarian response, the dose could be adjusted by 3 μg, with dose increases implemented not more frequently than once every 2 days and dose decreases implemented per investigator's judgement. The minimum daily dose was 6 μg, and the maximum daily dose was 24 μg. Participants could be treated for a maximum of 20 days. Coasting, use of dopamine agonist or any other drug to prevent early OHSS with the exception of GnRH agonist for triggering of final follicular maturation, was not allowed. | | OG001 | Placebo | Placebo was administered as single daily subcutaneous injection dialed to the same value (dose) as FE 999049. Participants could be treated for a maximum of 20 days. Coasting, use of dopamine agonist or any other drug to prevent early OHSS with the exception of GnRH agonist for triggering of final follicular maturation, was not allowed. |
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| Secondary | Number of Metaphase II Oocytes | The number of MII oocytes to oocytes retrieved for participants where all oocytes were inseminated using ICSI are presented. | The mITT analysis set comprised all randomized and exposed participants. Participants were analyzed according to planned treatment. | Posted | | Mean | Standard Deviation | number of MII oocytes | | On day of oocyte retrieval (up to 22 days after start of stimulation) | | | | ID | Title | Description |
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| OG000 | FE 999049 (Follitropin Delta) | FE 999049 was administered as single daily subcutaneous injections in the abdomen at a starting dose of 15 μg daily that was fixed for the first four stimulation days. Based on ovarian response, the dose could be adjusted by 3 μg, with dose increases implemented not more frequently than once every 2 days and dose decreases implemented per investigator's judgement. The minimum daily dose was 6 μg, and the maximum daily dose was 24 μg. Participants could be treated for a maximum of 20 days. Coasting, use of dopamine agonist or any other drug to prevent early OHSS with the exception of GnRH agonist for triggering of final follicular maturation, was not allowed. | | OG001 | Placebo | Placebo was administered as single daily subcutaneous injection dialed to the same value (dose) as FE 999049. Participants could be treated for a maximum of 20 days. Coasting, use of dopamine agonist or any other drug to prevent early OHSS with the exception of GnRH agonist for triggering of final follicular maturation, was not allowed. |
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| Secondary | Number of Fertilized Oocytes | An oocyte was defined as fertilized if it had 2 pronuclei (2PN) at 19h (±2h). | The mITT analysis set comprised all randomized and exposed participants. Participants were analyzed according to planned treatment. | Posted | | Mean | Standard Deviation | oocytes (number of fertilized oocytes) | | On day 1 after oocyte retrieval (up to 23 days after start of stimulation) | | | | ID | Title | Description |
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| OG000 | FE 999049 (Follitropin Delta) | FE 999049 was administered as single daily subcutaneous injections in the abdomen at a starting dose of 15 μg daily that was fixed for the first four stimulation days. Based on ovarian response, the dose could be adjusted by 3 μg, with dose increases implemented not more frequently than once every 2 days and dose decreases implemented per investigator's judgement. The minimum daily dose was 6 μg, and the maximum daily dose was 24 μg. Participants could be treated for a maximum of 20 days. Coasting, use of dopamine agonist or any other drug to prevent early OHSS with the exception of GnRH agonist for triggering of final follicular maturation, was not allowed. | | OG001 | Placebo | Placebo was administered as single daily subcutaneous injection dialed to the same value (dose) as FE 999049. Participants could be treated for a maximum of 20 days. Coasting, use of dopamine agonist or any other drug to prevent early OHSS with the exception of GnRH agonist for triggering of final follicular maturation, was not allowed. |
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| Secondary | Fertilization Rate | The fertilization rate was defined as the number of 2PN oocytes divided by the number of oocytes retrieved. Fertilization rate relative to oocytes retrieved has been reported. | The mITT analysis set comprised all randomized and exposed participants. Participants were analyzed according to planned treatment. | Posted | | Mean | Standard Deviation | percentage of fertilized oocytes | | On day 1 after oocyte retrieval (up to 23 days after start of stimulation) | | | | ID | Title | Description |
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| OG000 | FE 999049 (Follitropin Delta) | FE 999049 was administered as single daily subcutaneous injections in the abdomen at a starting dose of 15 μg daily that was fixed for the first four stimulation days. Based on ovarian response, the dose could be adjusted by 3 μg, with dose increases implemented not more frequently than once every 2 days and dose decreases implemented per investigator's judgement. The minimum daily dose was 6 μg, and the maximum daily dose was 24 μg. Participants could be treated for a maximum of 20 days. Coasting, use of dopamine agonist or any other drug to prevent early OHSS with the exception of GnRH agonist for triggering of final follicular maturation, was not allowed. | | OG001 | Placebo | Placebo was administered as single daily subcutaneous injection dialed to the same value (dose) as FE 999049. Participants could be treated for a maximum of 20 days. Coasting, use of dopamine agonist or any other drug to prevent early OHSS with the exception of GnRH agonist for triggering of final follicular maturation, was not allowed. |
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| Secondary | Number and Quality of Blastocysts on Day 5 After Oocyte Retrieval | Number of blastocysts (total and good-quality) on Day 5 are presented. The quality evaluation of blastocysts consisted of assessment of three parameters, as per the Gardner & Schoolcraft system: blastocyst expansion and hatching status (graded: 1-6), inner cell mass (graded: A-D) and trophectoderm (graded: A-D). A good-quality blastocyst was defined as a blastocyst of grade 3BB or higher. | The mITT analysis set comprised all randomized and exposed participants. Participants were analyzed according to planned treatment. | Posted | | Mean | Standard Deviation | blastocysts | | On day 5 after oocyte retrieval | | | | ID | Title | Description |
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| OG000 | FE 999049 (Follitropin Delta) | FE 999049 was administered as single daily subcutaneous injections in the abdomen at a starting dose of 15 μg daily that was fixed for the first four stimulation days. Based on ovarian response, the dose could be adjusted by 3 μg, with dose increases implemented not more frequently than once every 2 days and dose decreases implemented per investigator's judgement. The minimum daily dose was 6 μg, and the maximum daily dose was 24 μg. Participants could be treated for a maximum of 20 days. Coasting, use of dopamine agonist or any other drug to prevent early OHSS with the exception of GnRH agonist for triggering of final follicular maturation, was not allowed. | | OG001 | Placebo | Placebo was administered as single daily subcutaneous injection dialed to the same value (dose) as FE 999049. Participants could be treated for a maximum of 20 days. Coasting, use of dopamine agonist or any other drug to prevent early OHSS with the exception of GnRH agonist for triggering of final follicular maturation, was not allowed. |
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| Secondary | Endometrial Thickness on Stimulation Day 5 | Mean endometrial thickness is reported. | The mITT analysis set comprised all randomized and exposed participants. Participants were analyzed according to planned treatment. | Posted | | Mean | Standard Deviation | mm | | On stimulation day 5 | | | | ID | Title | Description |
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| OG000 | FE 999049 (Follitropin Delta) | FE 999049 was administered as single daily subcutaneous injections in the abdomen at a starting dose of 15 μg daily that was fixed for the first four stimulation days. Based on ovarian response, the dose could be adjusted by 3 μg, with dose increases implemented not more frequently than once every 2 days and dose decreases implemented per investigator's judgement. The minimum daily dose was 6 μg, and the maximum daily dose was 24 μg. Participants could be treated for a maximum of 20 days. Coasting, use of dopamine agonist or any other drug to prevent early OHSS with the exception of GnRH agonist for triggering of final follicular maturation, was not allowed. | | OG001 | Placebo | Placebo was administered as single daily subcutaneous injection dialed to the same value (dose) as FE 999049. Participants could be treated for a maximum of 20 days. Coasting, use of dopamine agonist or any other drug to prevent early OHSS with the exception of GnRH agonist for triggering of final follicular maturation, was not allowed. |
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| Secondary | Endometrial Thickness at End-of-stimulation | Mean endometrial thickness is reported. | The mITT analysis set comprised all randomized and exposed participants. Participants were analyzed according to planned treatment. | Posted | | Mean | Standard Deviation | mm | | At end-of-stimulation (up to 20 stimulation days) | | | | ID | Title | Description |
|---|
| OG000 | FE 999049 (Follitropin Delta) | FE 999049 was administered as single daily subcutaneous injections in the abdomen at a starting dose of 15 μg daily that was fixed for the first four stimulation days. Based on ovarian response, the dose could be adjusted by 3 μg, with dose increases implemented not more frequently than once every 2 days and dose decreases implemented per investigator's judgement. The minimum daily dose was 6 μg, and the maximum daily dose was 24 μg. Participants could be treated for a maximum of 20 days. Coasting, use of dopamine agonist or any other drug to prevent early OHSS with the exception of GnRH agonist for triggering of final follicular maturation, was not allowed. | | OG001 | Placebo | Placebo was administered as single daily subcutaneous injection dialed to the same value (dose) as FE 999049. Participants could be treated for a maximum of 20 days. Coasting, use of dopamine agonist or any other drug to prevent early OHSS with the exception of GnRH agonist for triggering of final follicular maturation, was not allowed. |
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| Secondary | Echogenicity Pattern on Stimulation Day 5 | The distribution of participants with hypoechogenic, isoechogenic, or hyperechogenic endometrium is reported | The mITT analysis set comprised all randomized and exposed participants. Participants were analyzed according to planned treatment. | Posted | | Number | | percentage of participants | | On stimulation day 5 | | | | ID | Title | Description |
|---|
| OG000 | FE 999049 (Follitropin Delta) | FE 999049 was administered as single daily subcutaneous injections in the abdomen at a starting dose of 15 μg daily that was fixed for the first four stimulation days. Based on ovarian response, the dose could be adjusted by 3 μg, with dose increases implemented not more frequently than once every 2 days and dose decreases implemented per investigator's judgement. The minimum daily dose was 6 μg, and the maximum daily dose was 24 μg. Participants could be treated for a maximum of 20 days. Coasting, use of dopamine agonist or any other drug to prevent early OHSS with the exception of GnRH agonist for triggering of final follicular maturation, was not allowed. | | OG001 | Placebo | Placebo was administered as single daily subcutaneous injection dialed to the same value (dose) as FE 999049. Participants could be treated for a maximum of 20 days. Coasting, use of dopamine agonist or any other drug to prevent early OHSS with the exception of GnRH agonist for triggering of final follicular maturation, was not allowed. |
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| Secondary | Echogenicity Pattern at End-of-stimulation | The distribution of participants with hypoechogenic, isoechogenic, or hyperechogenic endometrium is reported. | The mITT analysis set comprised all randomized and exposed participants. Participants were analyzed according to planned treatment. | Posted | | Number | | percentage of participants | | At end-of-stimulation (up to 20 stimulation days) | | | | ID | Title | Description |
|---|
| OG000 | FE 999049 (Follitropin Delta) | FE 999049 was administered as single daily subcutaneous injections in the abdomen at a starting dose of 15 μg daily that was fixed for the first four stimulation days. Based on ovarian response, the dose could be adjusted by 3 μg, with dose increases implemented not more frequently than once every 2 days and dose decreases implemented per investigator's judgement. The minimum daily dose was 6 μg, and the maximum daily dose was 24 μg. Participants could be treated for a maximum of 20 days. Coasting, use of dopamine agonist or any other drug to prevent early OHSS with the exception of GnRH agonist for triggering of final follicular maturation, was not allowed. | | OG001 | Placebo | Placebo was administered as single daily subcutaneous injection dialed to the same value (dose) as FE 999049. Participants could be treated for a maximum of 20 days. Coasting, use of dopamine agonist or any other drug to prevent early OHSS with the exception of GnRH agonist for triggering of final follicular maturation, was not allowed. |
|
| Secondary | Oocyte Utilization Rate | Defined as the number of blastocysts transferred or cryopreserved divided by the number of oocytes retrieved. Data in this endpoint are presented for the cryopreserved cycles. | The mITT analysis set comprised all randomized and exposed participants. Participants were analyzed according to planned treatment. | Posted | | Mean | Standard Deviation | blastocysts/oocyte retrieved | | On day of oocyte retrieval up to 12 months after start of COS | | | | ID | Title | Description |
|---|
| OG000 | FE 999049 (Follitropin Delta) | FE 999049 was administered as single daily subcutaneous injections in the abdomen at a starting dose of 15 μg daily that was fixed for the first four stimulation days. Based on ovarian response, the dose could be adjusted by 3 μg, with dose increases implemented not more frequently than once every 2 days and dose decreases implemented per investigator's judgement. The minimum daily dose was 6 μg, and the maximum daily dose was 24 μg. Participants could be treated for a maximum of 20 days. Coasting, use of dopamine agonist or any other drug to prevent early OHSS with the exception of GnRH agonist for triggering of final follicular maturation, was not allowed. | | OG001 | Placebo | Placebo was administered as single daily subcutaneous injection dialed to the same value (dose) as FE 999049. Participants could be treated for a maximum of 20 days. Coasting, use of dopamine agonist or any other drug to prevent early OHSS with the exception of GnRH agonist for triggering of final follicular maturation, was not allowed. |
|
| Secondary | Oocyte Efficiency Index | Defined as the cumulative number of ongoing pregnancies per oocyte retrieved. Data in this endpoint are presented for the cryopreserved cycles. The unit of measure for this endpoint is 'cumulative ongoing pregnancies/oocyte retrieved'. | The mITT analysis set comprised all randomized and exposed participants. Participants were analyzed according to planned treatment. | Posted | | Mean | Standard Deviation | ongoing pregnancies/oocyte retrieved | | 8-9 weeks after transfer | | | | ID | Title | Description |
|---|
| OG000 | FE 999049 (Follitropin Delta) | FE 999049 was administered as single daily subcutaneous injections in the abdomen at a starting dose of 15 μg daily that was fixed for the first four stimulation days. Based on ovarian response, the dose could be adjusted by 3 μg, with dose increases implemented not more frequently than once every 2 days and dose decreases implemented per investigator's judgement. The minimum daily dose was 6 μg, and the maximum daily dose was 24 μg. Participants could be treated for a maximum of 20 days. Coasting, use of dopamine agonist or any other drug to prevent early OHSS with the exception of GnRH agonist for triggering of final follicular maturation, was not allowed. | | OG001 | Placebo | Placebo was administered as single daily subcutaneous injection dialed to the same value (dose) as FE 999049. Participants could be treated for a maximum of 20 days. Coasting, use of dopamine agonist or any other drug to prevent early OHSS with the exception of GnRH agonist for triggering of final follicular maturation, was not allowed. |
|
| Secondary | Percentage of Blastocysts Surviving Cryopreservation | Data in this endpoint are presented for the cryopreserved cycles. The unit is number of blastocysts with observations. One participant can contribute with a range from zero to multiple blastocysts. | The mITT analysis set comprised all randomized and exposed participants. Participants were analyzed according to planned treatment. | Posted | | Number | | percentage of blastocysts | | 0 hour (+0.5 hour) after thawing | Number of blastocyst warmed | Number of blastocyst warmed | | ID | Title | Description |
|---|
| OG000 | FE 999049 (Follitropin Delta) | FE 999049 was administered as single daily subcutaneous injections in the abdomen at a starting dose of 15 μg daily that was fixed for the first four stimulation days. Based on ovarian response, the dose could be adjusted by 3 μg, with dose increases implemented not more frequently than once every 2 days and dose decreases implemented per investigator's judgement. The minimum daily dose was 6 μg, and the maximum daily dose was 24 μg. Participants could be treated for a maximum of 20 days. Coasting, use of dopamine agonist or any other drug to prevent early OHSS with the exception of GnRH agonist for triggering of final follicular maturation, was not allowed. |
| |
| Secondary | Percentage of Blastocysts With Re-expansion After Cryopreservation | Data in this endpoint are presented for the cryopreserved cycles. The unit is number of blastocysts with observations. One participant can contribute with a range from zero to multiple blastocysts. | The mITT analysis set comprised all randomized and exposed participants. Participants were analyzed according to planned treatment. | Posted | | Number | | percentage of blastocysts | | 2.5 hour (±0.5 hour) after thawing | Number of blastocyst warmed | Number of blastocyst warmed | | ID | Title | Description |
|---|
| OG000 | FE 999049 (Follitropin Delta) | FE 999049 was administered as single daily subcutaneous injections in the abdomen at a starting dose of 15 μg daily that was fixed for the first four stimulation days. Based on ovarian response, the dose could be adjusted by 3 μg, with dose increases implemented not more frequently than once every 2 days and dose decreases implemented per investigator's judgement. The minimum daily dose was 6 μg, and the maximum daily dose was 24 μg. Participants could be treated for a maximum of 20 days. Coasting, use of dopamine agonist or any other drug to prevent early OHSS with the exception of GnRH agonist for triggering of final follicular maturation, was not allowed. |
| |
| Secondary | Number of Cryopreserved Cycles Initiated Within 12 Months From the Start of COS | The total number of cryopreserved cycles initiated are reported. Data in this endpoint are presented for the cryopreserved cycles. One participant can contribute with a range from zero to multiple blastocysts. | The mITT analysis set comprised all randomized and exposed participants. Participants were analyzed according to planned treatment. | Posted | | Number | | Percentages of cycles | | Up to 12 months after start of stimulation | Cryopreserved cycles initiated | Cryopreserved cycles initiated | | ID | Title | Description |
|---|
| OG000 | FE 999049 (Follitropin Delta) | FE 999049 was administered as single daily subcutaneous injections in the abdomen at a starting dose of 15 μg daily that was fixed for the first four stimulation days. Based on ovarian response, the dose could be adjusted by 3 μg, with dose increases implemented not more frequently than once every 2 days and dose decreases implemented per investigator's judgement. The minimum daily dose was 6 μg, and the maximum daily dose was 24 μg. Participants could be treated for a maximum of 20 days. Coasting, use of dopamine agonist or any other drug to prevent early OHSS with the exception of GnRH agonist for triggering of final follicular maturation, was not allowed. |
| |
| Secondary | Number of Cryopreserved Cycles With Blastocyst Transfer | The total number of cryopreserved cycles with blastocyst transfer are reported. Data in this endpoint are presented for the cryopreserved cycles. One participant can contribute with a range from zero to multiple blastocysts. | The mITT analysis set comprised all randomized and exposed participants. Participants were analyzed according to planned treatment. | Posted | | Number | | Percentages of cycles | | Up to 12 months after start of stimulation | Cryopreserved cycles with transfer | Cryopreserved cycles with transfer | | ID | Title | Description |
|---|
| OG000 | FE 999049 (Follitropin Delta) | FE 999049 was administered as single daily subcutaneous injections in the abdomen at a starting dose of 15 μg daily that was fixed for the first four stimulation days. Based on ovarian response, the dose could be adjusted by 3 μg, with dose increases implemented not more frequently than once every 2 days and dose decreases implemented per investigator's judgement. The minimum daily dose was 6 μg, and the maximum daily dose was 24 μg. Participants could be treated for a maximum of 20 days. Coasting, use of dopamine agonist or any other drug to prevent early OHSS with the exception of GnRH agonist for triggering of final follicular maturation, was not allowed. |
| |
| Secondary | Circulating Concentrations of Anti-mullerian Hormone (AMH) | Blood samples for analysis of circulating concentrations of AMH were drawn. The median and inter-quartile range (IQR) of AMH levels on stimulation day 1, stimulation day 5, end-of-stimulation visit and oocyte retrieval visit are presented. | The mITT analysis set comprised all randomized and exposed participants. Participants were analyzed according to planned treatment. No circulating concentrations of AMH were assessed for the oocyte retrieval visit for the placebo arm, because no participants who received placebo became pregnant. | Posted | | Median | Inter-Quartile Range | pmol/L | | From screening to the day of oocyte retrieval (up to 22 days after start of stimulation) | | | | ID | Title | Description |
|---|
| OG000 | FE 999049 (Follitropin Delta) | FE 999049 was administered as single daily subcutaneous injections in the abdomen at a starting dose of 15 μg daily that was fixed for the first four stimulation days. Based on ovarian response, the dose could be adjusted by 3 μg, with dose increases implemented not more frequently than once every 2 days and dose decreases implemented per investigator's judgement. The minimum daily dose was 6 μg, and the maximum daily dose was 24 μg. Participants could be treated for a maximum of 20 days. Coasting, use of dopamine agonist or any other drug to prevent early OHSS with the exception of GnRH agonist for triggering of final follicular maturation, was not allowed. | | OG001 | Placebo | |
|
| Secondary | Circulating Concentrations of Follicle-stimulating Hormone (FSH) | Blood samples for analysis of circulating concentrations of FSH were drawn. The median and IQR of FSH levels on stimulation day 1, stimulation day 5, end-of-stimulation visit and oocyte retrieval visit are presented. | The mITT analysis set comprised all randomized and exposed participants. Participants were analyzed according to planned treatment. | Posted | | Median | Inter-Quartile Range | IU/L | | From screening to the day of oocyte retrieval (up to 22 days after start of stimulation) | | | | ID | Title | Description |
|---|
| OG000 | FE 999049 (Follitropin Delta) | FE 999049 was administered as single daily subcutaneous injections in the abdomen at a starting dose of 15 μg daily that was fixed for the first four stimulation days. Based on ovarian response, the dose could be adjusted by 3 μg, with dose increases implemented not more frequently than once every 2 days and dose decreases implemented per investigator's judgement. The minimum daily dose was 6 μg, and the maximum daily dose was 24 μg. Participants could be treated for a maximum of 20 days. Coasting, use of dopamine agonist or any other drug to prevent early OHSS with the exception of GnRH agonist for triggering of final follicular maturation, was not allowed. | | OG001 | Placebo | Placebo was administered as single daily subcutaneous injection dialed to the same value (dose) as FE 999049. Participants could be treated for a maximum of 20 days. Coasting, use of dopamine agonist or any other drug to prevent early OHSS with the exception of GnRH agonist for triggering of final follicular maturation, was not allowed. |
|
| Secondary | Circulating Concentrations of Luteinizing Hormone (LH) | Blood samples for analysis of circulating concentrations of LH were drawn. The median and IQR of LH levels on stimulation day 1, stimulation day 5, end-of-stimulation visit and oocyte retrieval visit are presented. | The mITT analysis set comprised all randomized and exposed participants. Participants were analyzed according to planned treatment. | Posted | | Median | Inter-Quartile Range | IU/L | | From screening to the day of oocyte retrieval (up to 22 days after start of stimulation) | | | | ID | Title | Description |
|---|
| OG000 | FE 999049 (Follitropin Delta) | FE 999049 was administered as single daily subcutaneous injections in the abdomen at a starting dose of 15 μg daily that was fixed for the first four stimulation days. Based on ovarian response, the dose could be adjusted by 3 μg, with dose increases implemented not more frequently than once every 2 days and dose decreases implemented per investigator's judgement. The minimum daily dose was 6 μg, and the maximum daily dose was 24 μg. Participants could be treated for a maximum of 20 days. Coasting, use of dopamine agonist or any other drug to prevent early OHSS with the exception of GnRH agonist for triggering of final follicular maturation, was not allowed. | | OG001 | Placebo | Placebo was administered as single daily subcutaneous injection dialed to the same value (dose) as FE 999049. Participants could be treated for a maximum of 20 days. Coasting, use of dopamine agonist or any other drug to prevent early OHSS with the exception of GnRH agonist for triggering of final follicular maturation, was not allowed. |
|
| Secondary | Circulating Concentrations of Estradiol | Blood samples for analysis of circulating concentrations of estradiol were drawn. The median and IQR of estradiol levels on stimulation day 1, stimulation day 5, end-of-stimulation visit and oocyte retrieval visit are presented. | The mITT analysis set comprised all randomized and exposed participants. Participants were analyzed according to planned treatment. | Posted | | Median | Inter-Quartile Range | pg/mL | | From screening to the day of oocyte retrieval (up to 22 days after start of stimulation) | | | | ID | Title | Description |
|---|
| OG000 | FE 999049 (Follitropin Delta) | FE 999049 was administered as single daily subcutaneous injections in the abdomen at a starting dose of 15 μg daily that was fixed for the first four stimulation days. Based on ovarian response, the dose could be adjusted by 3 μg, with dose increases implemented not more frequently than once every 2 days and dose decreases implemented per investigator's judgement. The minimum daily dose was 6 μg, and the maximum daily dose was 24 μg. Participants could be treated for a maximum of 20 days. Coasting, use of dopamine agonist or any other drug to prevent early OHSS with the exception of GnRH agonist for triggering of final follicular maturation, was not allowed. | | OG001 | Placebo | Placebo was administered as single daily subcutaneous injection dialed to the same value (dose) as FE 999049. Participants could be treated for a maximum of 20 days. Coasting, use of dopamine agonist or any other drug to prevent early OHSS with the exception of GnRH agonist for triggering of final follicular maturation, was not allowed. |
|
| Secondary | Circulating Concentrations of Progesterone | Blood samples for analysis of circulating concentrations of progesterone were drawn. The median and IQR of progesterone levels on stimulation day 1, stimulation day 5, end-of-stimulation visit and oocyte retrieval visit are presented. | The mITT analysis set comprised all randomized and exposed participants. Participants were analyzed according to planned treatment. | Posted | | Median | Inter-Quartile Range | ng/mL | | From screening to the day of oocyte retrieval (up to 22 days after start of stimulation) | | | | ID | Title | Description |
|---|
| OG000 | FE 999049 (Follitropin Delta) | FE 999049 was administered as single daily subcutaneous injections in the abdomen at a starting dose of 15 μg daily that was fixed for the first four stimulation days. Based on ovarian response, the dose could be adjusted by 3 μg, with dose increases implemented not more frequently than once every 2 days and dose decreases implemented per investigator's judgement. The minimum daily dose was 6 μg, and the maximum daily dose was 24 μg. Participants could be treated for a maximum of 20 days. Coasting, use of dopamine agonist or any other drug to prevent early OHSS with the exception of GnRH agonist for triggering of final follicular maturation, was not allowed. | | OG001 | Placebo | Placebo was administered as single daily subcutaneous injection dialed to the same value (dose) as FE 999049. Participants could be treated for a maximum of 20 days. Coasting, use of dopamine agonist or any other drug to prevent early OHSS with the exception of GnRH agonist for triggering of final follicular maturation, was not allowed. |
|
| Secondary | Circulating Concentrations of Inhibin A | Blood samples for analysis of circulating concentrations of inhibin A were drawn. The median and IQR of inhibin A levels on stimulation day 1, stimulation day 5, end-of-stimulation visit and oocyte retrieval visit are presented. | The mITT analysis set comprised all randomized and exposed participants. Participants were analyzed according to planned treatment. No circulating concentrations of Inhibin A were assessed for the oocyte retrieval visit for the placebo arm, because no participants who received placebo became pregnant. | Posted | | Median | Inter-Quartile Range | pg/mL | | From screening to the day of oocyte retrieval (up to 22 days after start of stimulation) | | | | ID | Title | Description |
|---|
| OG000 | FE 999049 (Follitropin Delta) | FE 999049 was administered as single daily subcutaneous injections in the abdomen at a starting dose of 15 μg daily that was fixed for the first four stimulation days. Based on ovarian response, the dose could be adjusted by 3 μg, with dose increases implemented not more frequently than once every 2 days and dose decreases implemented per investigator's judgement. The minimum daily dose was 6 μg, and the maximum daily dose was 24 μg. Participants could be treated for a maximum of 20 days. Coasting, use of dopamine agonist or any other drug to prevent early OHSS with the exception of GnRH agonist for triggering of final follicular maturation, was not allowed. | | OG001 | Placebo | Placebo was administered as single daily subcutaneous injection dialed to the same value (dose) as FE 999049. Participants could be treated for a maximum of 20 days. Coasting, use of dopamine agonist or any other drug to prevent early OHSS with the exception of GnRH agonist for triggering of final follicular maturation, was not allowed. |
|
| Secondary | Circulating Concentrations of Inhibin B | Blood samples for analysis of circulating concentrations of inhibin B were drawn. The median and IQR of inhibin B levels on stimulation day 1, stimulation day 5, end-of-stimulation visit and oocyte retrieval visit are presented. | The mITT analysis set comprised all randomized and exposed participants. Participants were analyzed according to planned treatment. No circulating concentrations of Inhibin B were assessed for the oocyte retrieval visit for the placebo arm, because no participants who received placebo became pregnant. | Posted | | Median | Inter-Quartile Range | pg/mL | | From screening to the day of oocyte retrieval (up to 22 days after start of stimulation) | | | | ID | Title | Description |
|---|
| OG000 | FE 999049 (Follitropin Delta) | FE 999049 was administered as single daily subcutaneous injections in the abdomen at a starting dose of 15 μg daily that was fixed for the first four stimulation days. Based on ovarian response, the dose could be adjusted by 3 μg, with dose increases implemented not more frequently than once every 2 days and dose decreases implemented per investigator's judgement. The minimum daily dose was 6 μg, and the maximum daily dose was 24 μg. Participants could be treated for a maximum of 20 days. Coasting, use of dopamine agonist or any other drug to prevent early OHSS with the exception of GnRH agonist for triggering of final follicular maturation, was not allowed. | | OG001 | Placebo | Placebo was administered as single daily subcutaneous injection dialed to the same value (dose) as FE 999049. Participants could be treated for a maximum of 20 days. Coasting, use of dopamine agonist or any other drug to prevent early OHSS with the exception of GnRH agonist for triggering of final follicular maturation, was not allowed. |
|
| Secondary | Total Gonadotropin Dose | Calculated by start dates, end dates and daily dose of IMP. | The mITT analysis set comprised all randomized and exposed participants. Participants were analyzed according to planned treatment. | Posted | | Mean | Standard Deviation | microgram of dose | | Up to 20 stimulation days | | | | ID | Title | Description |
|---|
| OG000 | FE 999049 (Follitropin Delta) | FE 999049 was administered as single daily subcutaneous injections in the abdomen at a starting dose of 15 μg daily that was fixed for the first four stimulation days. Based on ovarian response, the dose could be adjusted by 3 μg, with dose increases implemented not more frequently than once every 2 days and dose decreases implemented per investigator's judgement. The minimum daily dose was 6 μg, and the maximum daily dose was 24 μg. Participants could be treated for a maximum of 20 days. Coasting, use of dopamine agonist or any other drug to prevent early OHSS with the exception of GnRH agonist for triggering of final follicular maturation, was not allowed. | | OG001 | Placebo | Placebo was administered as single daily subcutaneous injection dialed to the same value (dose) as FE 999049. Participants could be treated for a maximum of 20 days. Coasting, use of dopamine agonist or any other drug to prevent early OHSS with the exception of GnRH agonist for triggering of final follicular maturation, was not allowed. |
| |
| Secondary | Number of Stimulation Days | Calculated by start dates and end dates. | The mITT analysis set comprised all randomized and exposed participants. Participants were analyzed according to planned treatment. | Posted | | Mean | Standard Deviation | days | | Up to 20 stimulation days | | | | ID | Title | Description |
|---|
| OG000 | FE 999049 (Follitropin Delta) | FE 999049 was administered as single daily subcutaneous injections in the abdomen at a starting dose of 15 μg daily that was fixed for the first four stimulation days. Based on ovarian response, the dose could be adjusted by 3 μg, with dose increases implemented not more frequently than once every 2 days and dose decreases implemented per investigator's judgement. The minimum daily dose was 6 μg, and the maximum daily dose was 24 μg. Participants could be treated for a maximum of 20 days. Coasting, use of dopamine agonist or any other drug to prevent early OHSS with the exception of GnRH agonist for triggering of final follicular maturation, was not allowed. | | OG001 | Placebo | Placebo was administered as single daily subcutaneous injection dialed to the same value (dose) as FE 999049. Participants could be treated for a maximum of 20 days. Coasting, use of dopamine agonist or any other drug to prevent early OHSS with the exception of GnRH agonist for triggering of final follicular maturation, was not allowed. |
| |
| Secondary | Proportion of Participants With Investigator-requested Gonadotropin Dose Adjustments | Investigator-requested decreases and increases of the gonadotropin dose. | The mITT analysis set comprised all randomized and exposed participants. Participants were analyzed according to planned treatment. | Posted | | Number | | percentage of participants | | Stimulation Day 5 | | | | ID | Title | Description |
|---|
| OG000 | FE 999049 (Follitropin Delta) | FE 999049 was administered as single daily subcutaneous injections in the abdomen at a starting dose of 15 μg daily that was fixed for the first four stimulation days. Based on ovarian response, the dose could be adjusted by 3 μg, with dose increases implemented not more frequently than once every 2 days and dose decreases implemented per investigator's judgement. The minimum daily dose was 6 μg, and the maximum daily dose was 24 μg. Participants could be treated for a maximum of 20 days. Coasting, use of dopamine agonist or any other drug to prevent early OHSS with the exception of GnRH agonist for triggering of final follicular maturation, was not allowed. | | OG001 | Placebo | Placebo was administered as single daily subcutaneous injection dialed to the same value (dose) as FE 999049. Participants could be treated for a maximum of 20 days. Coasting, use of dopamine agonist or any other drug to prevent early OHSS with the exception of GnRH agonist for triggering of final follicular maturation, was not allowed. |
|
| Secondary | Percentage of Participants With Adverse Events (AEs) | Any AE occurring after start of IMP and before the end-of-trial visit, or a pre-treatment AE or pre-existing medical condition that worsens in intensity after start of IMP and before the end-of-trial visit was considered treatment-emergent, and is presented for this endpoint. Data in this endpoint are presented for the fresh cycle. | | Posted | | Number | | percentage of participants | | From time of signing informed consent until the end-of-cycle visit in the fresh cycle (approximately 6 months) | | | | ID | Title | Description |
|---|
| OG000 | FE 999049 (Follitropin Delta) | FE 999049 was administered as single daily subcutaneous injections in the abdomen at a starting dose of 15 μg daily that was fixed for the first four stimulation days. Based on ovarian response, the dose could be adjusted by 3 μg, with dose increases implemented not more frequently than once every 2 days and dose decreases implemented per investigator's judgement. The minimum daily dose was 6 μg, and the maximum daily dose was 24 μg. Participants could be treated for a maximum of 20 days. Coasting, use of dopamine agonist or any other drug to prevent early OHSS with the exception of GnRH agonist for triggering of final follicular maturation, was not allowed. | | OG001 | Placebo | Placebo was administered as single daily subcutaneous injection dialed to the same value (dose) as FE 999049. Participants could be treated for a maximum of 20 days. Coasting, use of dopamine agonist or any other drug to prevent early OHSS with the exception of GnRH agonist for triggering of final follicular maturation, was not allowed. |
|
| Secondary | Intensity of AEs | The intensity of AE was classified using the following 3-point scale: mild = awareness of signs or symptoms, but no disruption of usual activity; moderate = event sufficient to affect usual activity (disturbing); or severe = inability to work or perform usual activities (unacceptable). Data in this endpoint are presented for the fresh cycle. | The safety analysis set comprised all randomized and exposed participants. Participants were analyzed according to actual treatment received. | Posted | | Number | | percentage of participants | | From time of signing informed consent until the end-of-cycle visit in the fresh cycle (up to approximately 6 months) | | | | ID | Title | Description |
|---|
| OG000 | FE 999049 (Follitropin Delta) | FE 999049 was administered as single daily subcutaneous injections in the abdomen at a starting dose of 15 μg daily that was fixed for the first four stimulation days. Based on ovarian response, the dose could be adjusted by 3 μg, with dose increases implemented not more frequently than once every 2 days and dose decreases implemented per investigator's judgement. The minimum daily dose was 6 μg, and the maximum daily dose was 24 μg. Participants could be treated for a maximum of 20 days. Coasting, use of dopamine agonist or any other drug to prevent early OHSS with the exception of GnRH agonist for triggering of final follicular maturation, was not allowed. | | OG001 | Placebo | Placebo was administered as single daily subcutaneous injection dialed to the same value (dose) as FE 999049. Participants could be treated for a maximum of 20 days. Coasting, use of dopamine agonist or any other drug to prevent early OHSS with the exception of GnRH agonist for triggering of final follicular maturation, was not allowed. |
|
| Secondary | Changes in Circulating Levels of Clinical Chemistry Compared to Baseline: Albumin, Protein | Blood samples were collected for the analysis of clinical chemistry parameters including: Albumin and protein. Data in this endpoint are presented for the fresh cycle. | The safety analysis set comprised all randomized and exposed participants. Participants were analyzed according to actual treatment received. | Posted | | Mean | Standard Deviation | g/L | | From screening (baseline) to the end-of-cycle visit in the fresh cycle (approximately 6 months) | | | | ID | Title | Description |
|---|
| OG000 | FE 999049 (Follitropin Delta) | FE 999049 was administered as single daily subcutaneous injections in the abdomen at a starting dose of 15 μg daily that was fixed for the first four stimulation days. Based on ovarian response, the dose could be adjusted by 3 μg, with dose increases implemented not more frequently than once every 2 days and dose decreases implemented per investigator's judgement. The minimum daily dose was 6 μg, and the maximum daily dose was 24 μg. Participants could be treated for a maximum of 20 days. Coasting, use of dopamine agonist or any other drug to prevent early OHSS with the exception of GnRH agonist for triggering of final follicular maturation, was not allowed. | | OG001 | Placebo | Placebo was administered as single daily subcutaneous injection dialed to the same value (dose) as FE 999049. Participants could be treated for a maximum of 20 days. Coasting, use of dopamine agonist or any other drug to prevent early OHSS with the exception of GnRH agonist for triggering of final follicular maturation, was not allowed. |
|
| Secondary | Changes in Circulating Levels of Clinical Chemistry Compared to Baseline: Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase and Gamma Glutamyl Transferase | Blood samples were collected for the analysis of clinical chemistry parameters including: Alanine aminotransferase, alkaline phosphatase, aspartate aminotransferase and gamma glutamyl transferase. Data in this endpoint are presented for the fresh cycle. | The safety analysis set comprised all randomized and exposed participants. Participants were analyzed according to actual treatment received. | Posted | | Mean | Standard Deviation | IU/L | | From screening (baseline) to the end-of-cycle visit in the fresh cycle (approximately 6 months) | | | | ID | Title | Description |
|---|
| OG000 | FE 999049 (Follitropin Delta) | FE 999049 was administered as single daily subcutaneous injections in the abdomen at a starting dose of 15 μg daily that was fixed for the first four stimulation days. Based on ovarian response, the dose could be adjusted by 3 μg, with dose increases implemented not more frequently than once every 2 days and dose decreases implemented per investigator's judgement. The minimum daily dose was 6 μg, and the maximum daily dose was 24 μg. Participants could be treated for a maximum of 20 days. Coasting, use of dopamine agonist or any other drug to prevent early OHSS with the exception of GnRH agonist for triggering of final follicular maturation, was not allowed. | | OG001 | Placebo | |
|
| Secondary | Changes in Circulating Levels of Clinical Chemistry Compared to Baseline: Bicarbonate, Blood Urea Nitrogen, Calcium, Chloride, Cholesterol, Glucose, Phosphate, Potassium and Sodium | Blood samples were collected for the analysis of clinical chemistry parameters including: Bicarbonate, blood urea nitrogen, calcium, chloride, cholesterol, glucose, Phosphate, Potassium and Sodium. Data in this endpoint are presented for the fresh cycle. | The safety analysis set comprised all randomized and exposed participants. Participants were analyzed according to actual treatment received. | Posted | | Mean | Standard Deviation | mmol/L | | From screening (baseline) to the end-of-cycle visit in the fresh cycle (approximately 6 months) | | | | ID | Title | Description |
|---|
| OG000 | FE 999049 (Follitropin Delta) | FE 999049 was administered as single daily subcutaneous injections in the abdomen at a starting dose of 15 μg daily that was fixed for the first four stimulation days. Based on ovarian response, the dose could be adjusted by 3 μg, with dose increases implemented not more frequently than once every 2 days and dose decreases implemented per investigator's judgement. The minimum daily dose was 6 μg, and the maximum daily dose was 24 μg. Participants could be treated for a maximum of 20 days. Coasting, use of dopamine agonist or any other drug to prevent early OHSS with the exception of GnRH agonist for triggering of final follicular maturation, was not allowed. | | OG001 | Placebo | |
|
| Secondary | Changes in Circulating Levels of Clinical Chemistry Compared to Baseline: Direct Bilirubin, Total Bilirubin, Creatinine, Urate | Blood samples were collected for the analysis of clinical chemistry parameters including: Direct bilirubin, total bilirubin, creatinine, urate. Data in this endpoint are presented for the fresh cycle. | The safety analysis set comprised all randomized and exposed participants. Participants were analyzed according to actual treatment received. | Posted | | Mean | Standard Deviation | umol/L | | From screening (baseline) to the end-of-cycle visit in the fresh cycle (approximately 6 months) | | | | ID | Title | Description |
|---|
| OG000 | FE 999049 (Follitropin Delta) | FE 999049 was administered as single daily subcutaneous injections in the abdomen at a starting dose of 15 μg daily that was fixed for the first four stimulation days. Based on ovarian response, the dose could be adjusted by 3 μg, with dose increases implemented not more frequently than once every 2 days and dose decreases implemented per investigator's judgement. The minimum daily dose was 6 μg, and the maximum daily dose was 24 μg. Participants could be treated for a maximum of 20 days. Coasting, use of dopamine agonist or any other drug to prevent early OHSS with the exception of GnRH agonist for triggering of final follicular maturation, was not allowed. | | OG001 | Placebo | Placebo was administered as single daily subcutaneous injection dialed to the same value (dose) as FE 999049. Participants could be treated for a maximum of 20 days. Coasting, use of dopamine agonist or any other drug to prevent early OHSS with the exception of GnRH agonist for triggering of final follicular maturation, was not allowed. |
|
| Secondary | Changes in Circulating Levels of Clinical Chemistry Compared to Baseline: Lactate Dehydrogenase | Blood samples were collected for the analysis of clinical chemistry parameters including: Lactate dehydrogenase. Data in this endpoint are presented for the fresh cycle. | The safety analysis set comprised all randomized and exposed participants. Participants were analyzed according to actual treatment received. | Posted | | Mean | Standard Deviation | U/L | | From screening (baseline) to the end-of-cycle visit in the fresh cycle (approximately 6 months) | | | | ID | Title | Description |
|---|
| OG000 | FE 999049 (Follitropin Delta) | FE 999049 was administered as single daily subcutaneous injections in the abdomen at a starting dose of 15 μg daily that was fixed for the first four stimulation days. Based on ovarian response, the dose could be adjusted by 3 μg, with dose increases implemented not more frequently than once every 2 days and dose decreases implemented per investigator's judgement. The minimum daily dose was 6 μg, and the maximum daily dose was 24 μg. Participants could be treated for a maximum of 20 days. Coasting, use of dopamine agonist or any other drug to prevent early OHSS with the exception of GnRH agonist for triggering of final follicular maturation, was not allowed. | | OG001 | Placebo | Placebo was administered as single daily subcutaneous injection dialed to the same value (dose) as FE 999049. Participants could be treated for a maximum of 20 days. Coasting, use of dopamine agonist or any other drug to prevent early OHSS with the exception of GnRH agonist for triggering of final follicular maturation, was not allowed. |
|
| Secondary | Changes in Haematology Parameters Compared to Baseline: Erythrocytes | Blood samples were collected for the analysis of haematology parameter including: Erythrocytes. Data in this endpoint are presented for the fresh cycle. | The safety analysis set comprised all randomized and exposed participants. Participants were analyzed according to actual treatment received. | Posted | | Mean | Standard Deviation | 10^12 cells/L | | From screening to the end-of-cycle visit in the fresh cycle (approximately 6 months) | | | | ID | Title | Description |
|---|
| OG000 | FE 999049 (Follitropin Delta) | FE 999049 was administered as single daily subcutaneous injections in the abdomen at a starting dose of 15 μg daily that was fixed for the first four stimulation days. Based on ovarian response, the dose could be adjusted by 3 μg, with dose increases implemented not more frequently than once every 2 days and dose decreases implemented per investigator's judgement. The minimum daily dose was 6 μg, and the maximum daily dose was 24 μg. Participants could be treated for a maximum of 20 days. Coasting, use of dopamine agonist or any other drug to prevent early OHSS with the exception of GnRH agonist for triggering of final follicular maturation, was not allowed. | | OG001 | Placebo | Placebo was administered as single daily subcutaneous injection dialed to the same value (dose) as FE 999049. Participants could be treated for a maximum of 20 days. Coasting, use of dopamine agonist or any other drug to prevent early OHSS with the exception of GnRH agonist for triggering of final follicular maturation, was not allowed. |
|
| Secondary | Changes in Haematology Parameters Compared to Baseline: Haemoglobin | Blood samples were collected for the analysis of haematology parameters including: Haemoglobin. Data in this endpoint are presented for the fresh cycle. | The safety analysis set comprised all randomized and exposed participants. Participants were analyzed according to actual treatment received. | Posted | | Mean | Standard Deviation | g/L | | From screening (baseline) to the end-of-cycle visit in the fresh cycle (approximately 6 months) | | | | ID | Title | Description |
|---|
| OG000 | FE 999049 (Follitropin Delta) | FE 999049 was administered as single daily subcutaneous injections in the abdomen at a starting dose of 15 μg daily that was fixed for the first four stimulation days. Based on ovarian response, the dose could be adjusted by 3 μg, with dose increases implemented not more frequently than once every 2 days and dose decreases implemented per investigator's judgement. The minimum daily dose was 6 μg, and the maximum daily dose was 24 μg. Participants could be treated for a maximum of 20 days. Coasting, use of dopamine agonist or any other drug to prevent early OHSS with the exception of GnRH agonist for triggering of final follicular maturation, was not allowed. | | OG001 | Placebo | Placebo was administered as single daily subcutaneous injection dialed to the same value (dose) as FE 999049. Participants could be treated for a maximum of 20 days. Coasting, use of dopamine agonist or any other drug to prevent early OHSS with the exception of GnRH agonist for triggering of final follicular maturation, was not allowed. |
|
| Secondary | Changes in Haematology Parameters Compared to Baseline: Haematocrit | Blood samples were collected for the analysis of haematology parameter including: Haematocrit. Data in this endpoint are presented for the fresh cycle. | The safety analysis set comprised all randomized and exposed participants. Participants were analyzed according to actual treatment received. | Posted | | Mean | Standard Deviation | ratio | | From screening (baseline) to the end-of-cycle visit in the fresh cycle (approximately 6 months) | | | | ID | Title | Description |
|---|
| OG000 | FE 999049 (Follitropin Delta) | FE 999049 was administered as single daily subcutaneous injections in the abdomen at a starting dose of 15 μg daily that was fixed for the first four stimulation days. Based on ovarian response, the dose could be adjusted by 3 μg, with dose increases implemented not more frequently than once every 2 days and dose decreases implemented per investigator's judgement. The minimum daily dose was 6 μg, and the maximum daily dose was 24 μg. Participants could be treated for a maximum of 20 days. Coasting, use of dopamine agonist or any other drug to prevent early OHSS with the exception of GnRH agonist for triggering of final follicular maturation, was not allowed. | | OG001 | Placebo | Placebo was administered as single daily subcutaneous injection dialed to the same value (dose) as FE 999049. Participants could be treated for a maximum of 20 days. Coasting, use of dopamine agonist or any other drug to prevent early OHSS with the exception of GnRH agonist for triggering of final follicular maturation, was not allowed. |
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| Secondary | Changes in Haematology Parameters Compared to Baseline: Erythrocyte Mean Corpuscular Volume | Blood samples were collected for the analysis of haematology parameter including: Erythrocyte mean corpuscular volume. Data in this endpoint are presented for the fresh cycle. | The safety analysis set comprised all randomized and exposed participants. Participants were analyzed according to actual treatment received. | Posted | | Mean | Standard Deviation | fL | | From screening (baseline) to the end-of-cycle visit in the fresh cycle (approximately 6 months) | | | | ID | Title | Description |
|---|
| OG000 | FE 999049 (Follitropin Delta) | FE 999049 was administered as single daily subcutaneous injections in the abdomen at a starting dose of 15 μg daily that was fixed for the first four stimulation days. Based on ovarian response, the dose could be adjusted by 3 μg, with dose increases implemented not more frequently than once every 2 days and dose decreases implemented per investigator's judgement. The minimum daily dose was 6 μg, and the maximum daily dose was 24 μg. Participants could be treated for a maximum of 20 days. Coasting, use of dopamine agonist or any other drug to prevent early OHSS with the exception of GnRH agonist for triggering of final follicular maturation, was not allowed. | | OG001 | Placebo | Placebo was administered as single daily subcutaneous injection dialed to the same value (dose) as FE 999049. Participants could be treated for a maximum of 20 days. Coasting, use of dopamine agonist or any other drug to prevent early OHSS with the exception of GnRH agonist for triggering of final follicular maturation, was not allowed. |
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| Secondary | Changes in Haematology Parameters Compared to Baseline: Leukocytes and Platelets | Blood samples were collected for the analysis of haematology parameters including: Leukocytes and platelets. Data in this endpoint are presented for the fresh cycle. | The safety analysis set comprised all randomized and exposed participants. Participants were analyzed according to actual treatment received. | Posted | | Mean | Standard Deviation | 10^9 cells/L | | From screening (baseline) to the end-of-cycle visit in the fresh cycle (approximately 6 months) | | | | ID | Title | Description |
|---|
| OG000 | FE 999049 (Follitropin Delta) | FE 999049 was administered as single daily subcutaneous injections in the abdomen at a starting dose of 15 μg daily that was fixed for the first four stimulation days. Based on ovarian response, the dose could be adjusted by 3 μg, with dose increases implemented not more frequently than once every 2 days and dose decreases implemented per investigator's judgement. The minimum daily dose was 6 μg, and the maximum daily dose was 24 μg. Participants could be treated for a maximum of 20 days. Coasting, use of dopamine agonist or any other drug to prevent early OHSS with the exception of GnRH agonist for triggering of final follicular maturation, was not allowed. | | OG001 | Placebo | Placebo was administered as single daily subcutaneous injection dialed to the same value (dose) as FE 999049. Participants could be treated for a maximum of 20 days. Coasting, use of dopamine agonist or any other drug to prevent early OHSS with the exception of GnRH agonist for triggering of final follicular maturation, was not allowed. |
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| Secondary | Changes in Haematology Parameters Compared to Baseline: Erythrocyte Mean Corpuscular Hemoglobin | Blood samples were collected for the analysis of haematology parameter including: Erythrocyte mean corpuscular haemoglobin. Data in this endpoint are presented for the fresh cycle. | The safety analysis set comprised all randomized and exposed participants. Participants were analyzed according to actual treatment received. | Posted | | Mean | Standard Deviation | picogram | | From screening (baseline) to the end-of-cycle visit in the fresh cycle (approximately 6 months) | | | | ID | Title | Description |
|---|
| OG000 | FE 999049 (Follitropin Delta) | FE 999049 was administered as single daily subcutaneous injections in the abdomen at a starting dose of 15 μg daily that was fixed for the first four stimulation days. Based on ovarian response, the dose could be adjusted by 3 μg, with dose increases implemented not more frequently than once every 2 days and dose decreases implemented per investigator's judgement. The minimum daily dose was 6 μg, and the maximum daily dose was 24 μg. Participants could be treated for a maximum of 20 days. Coasting, use of dopamine agonist or any other drug to prevent early OHSS with the exception of GnRH agonist for triggering of final follicular maturation, was not allowed. | | OG001 | Placebo | Placebo was administered as single daily subcutaneous injection dialed to the same value (dose) as FE 999049. Participants could be treated for a maximum of 20 days. Coasting, use of dopamine agonist or any other drug to prevent early OHSS with the exception of GnRH agonist for triggering of final follicular maturation, was not allowed. |
|
| Secondary | Changes in Haematology Parameters Compared to Baseline: Erythrocyte Mean Corpuscular Haemoglobin Concentration | Blood samples were collected for the analysis of haematology parameter including: Erythrocyte mean corpuscular haemoglobin concentration. Data in this endpoint are presented for the fresh cycle. | The safety analysis set comprised all randomized and exposed participants. Participants were analyzed according to actual treatment received. | Posted | | Mean | Standard Deviation | mmol/L | | From screening (baseline) to the end-of-cycle visit in the fresh cycle (approximately 6 months) | | | | ID | Title | Description |
|---|
| OG000 | FE 999049 (Follitropin Delta) | FE 999049 was administered as single daily subcutaneous injections in the abdomen at a starting dose of 15 μg daily that was fixed for the first four stimulation days. Based on ovarian response, the dose could be adjusted by 3 μg, with dose increases implemented not more frequently than once every 2 days and dose decreases implemented per investigator's judgement. The minimum daily dose was 6 μg, and the maximum daily dose was 24 μg. Participants could be treated for a maximum of 20 days. Coasting, use of dopamine agonist or any other drug to prevent early OHSS with the exception of GnRH agonist for triggering of final follicular maturation, was not allowed. | | OG001 | Placebo | Placebo was administered as single daily subcutaneous injection dialed to the same value (dose) as FE 999049. Participants could be treated for a maximum of 20 days. Coasting, use of dopamine agonist or any other drug to prevent early OHSS with the exception of GnRH agonist for triggering of final follicular maturation, was not allowed. |
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| Secondary | Changes in Haematology Parameters Compared to Baseline: Basophils/Leukocytes, Eosinophils/Leukocytes, Lymphocytes/Leukocytes, Monocytes/Leukocytes and Neutrophils/Leukocytes | Blood samples were collected for the analysis of haematology parameters including: Basophils/leukocytes, eosinophils/ leukocytes, lymphocytes/leukocytes, monocytes/leukocytes and neutrophils/leukocytes. Data in this endpoint are presented for the fresh cycle. | The safety analysis set comprised all randomized and exposed participants. Participants were analyzed according to actual treatment received. | Posted | | Mean | Standard Deviation | percentage | | From screening (baseline) to the end-of-cycle visit in the fresh cycle (approximately 6 months) | | | | ID | Title | Description |
|---|
| OG000 | FE 999049 (Follitropin Delta) | FE 999049 was administered as single daily subcutaneous injections in the abdomen at a starting dose of 15 μg daily that was fixed for the first four stimulation days. Based on ovarian response, the dose could be adjusted by 3 μg, with dose increases implemented not more frequently than once every 2 days and dose decreases implemented per investigator's judgement. The minimum daily dose was 6 μg, and the maximum daily dose was 24 μg. Participants could be treated for a maximum of 20 days. Coasting, use of dopamine agonist or any other drug to prevent early OHSS with the exception of GnRH agonist for triggering of final follicular maturation, was not allowed. | | OG001 | Placebo | |
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| Secondary | Proportion of Subjects With Markedly Abnormal Changes of Clinical Chemistry Parameters: Alanine Aminotransferase, Aspartate Aminotransferase, Bicarbonate, Calcium, Potassium | The table represents the percentage of participants in each group with normal baseline values and markedly abnormal end-of-stimulation or end-of-cycle visit values for alanine aminotransferase, aspartate aminotransferase, bicarbonate, calcium, potassium. Data in this endpoint are presented for the fresh cycle. | The safety analysis set comprised all randomized and exposed participants. Participants were analyzed according to actual treatment received. | Posted | | Number | | percentage of participants | | From screening (baseline) to the end-of-cycle visit in the fresh cycle (approximately 6 months) | | | | ID | Title | Description |
|---|
| OG000 | FE 999049 (Follitropin Delta) | FE 999049 was administered as single daily subcutaneous injections in the abdomen at a starting dose of 15 μg daily that was fixed for the first four stimulation days. Based on ovarian response, the dose could be adjusted by 3 μg, with dose increases implemented not more frequently than once every 2 days and dose decreases implemented per investigator's judgement. The minimum daily dose was 6 μg, and the maximum daily dose was 24 μg. Participants could be treated for a maximum of 20 days. Coasting, use of dopamine agonist or any other drug to prevent early OHSS with the exception of GnRH agonist for triggering of final follicular maturation, was not allowed. | | OG001 | Placebo |
|
| Secondary | Proportion of Subjects With Markedly Abnormal Changes of Haematology Parameters: Leukocytes, Eosinophils/Leukocytes, Lymphocytes/Leukocytes, Neutrophils/Leukocytes | The table represents the percentage of participants in each group with normal baseline values and markedly abnormal end-of-stimulation or end-of-cycle visit values for Leukocytes, eosinophils/leukocytes, lymphocytes/leukocytes and neutrophils/leukocytes. Data in this endpoint are presented for the fresh cycle. | The safety analysis set comprised all randomized and exposed participants. Participants were analyzed according to actual treatment received. | Posted | | Number | | percentage of participants | | From screening (baseline) to the end-of-stimulation visit and end-of-cycle visit in the fresh cycle (approximately 6 months) | | | | ID | Title | Description |
|---|
| OG000 | FE 999049 (Follitropin Delta) | FE 999049 was administered as single daily subcutaneous injections in the abdomen at a starting dose of 15 μg daily that was fixed for the first four stimulation days. Based on ovarian response, the dose could be adjusted by 3 μg, with dose increases implemented not more frequently than once every 2 days and dose decreases implemented per investigator's judgement. The minimum daily dose was 6 μg, and the maximum daily dose was 24 μg. Participants could be treated for a maximum of 20 days. Coasting, use of dopamine agonist or any other drug to prevent early OHSS with the exception of GnRH agonist for triggering of final follicular maturation, was not allowed. | | OG001 | Placebo |
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| Secondary | Frequency and Intensity of Injection Site Reactions (Redness, Pain, Itching, Swelling and Bruising) Assessed by the Subject During the Stimulation Period | Assessed by the participant during the stimulation period. Participants assessed the injection site reactions (redness, pain, itching, swelling and bruising) three times daily: immediately after the injection, 30 minutes after the injection and 24 hours after the injection. | The safety analysis set comprised all randomized and exposed participants. Participants were analyzed according to actual treatment received. | Posted | | Number | | percentage of events | | End-of-stimulation (up to 20 stimulation days) | Total number of events | Total number of events | | ID | Title | Description |
|---|
| OG000 | FE 999049 (Follitropin Delta) | FE 999049 was administered as single daily subcutaneous injections in the abdomen at a starting dose of 15 μg daily that was fixed for the first four stimulation days. Based on ovarian response, the dose could be adjusted by 3 μg, with dose increases implemented not more frequently than once every 2 days and dose decreases implemented per investigator's judgement. The minimum daily dose was 6 μg, and the maximum daily dose was 24 μg. Participants could be treated for a maximum of 20 days. Coasting, use of dopamine agonist or any other drug to prevent early OHSS with the exception of GnRH agonist for triggering of final follicular maturation, was not allowed. | | OG001 | Placebo | Placebo was administered as single daily subcutaneous injection dialed to the same value (dose) as FE 999049. Participants could be treated for a maximum of 20 days. Coasting, use of dopamine agonist or any other drug to prevent early OHSS with the exception of GnRH agonist for triggering of final follicular maturation, was not allowed. |
|
| Secondary | Intensity of Injection Site Reactions (Redness, Pain, Itching, Swelling and Bruising) Assessed by the Subject During the Stimulation Period | Assessed by the participant during the stimulation period as mild, moderate or severe. | The safety analysis set comprised all randomized and exposed participants. Participants were analyzed according to actual treatment received. | Posted | | Number | | percentage of events | | End-of-stimulation (up to 20 stimulation days) | Total number of events | Total number of events | | ID | Title | Description |
|---|
| OG000 | FE 999049 (Follitropin Delta) | FE 999049 was administered as single daily subcutaneous injections in the abdomen at a starting dose of 15 μg daily that was fixed for the first four stimulation days. Based on ovarian response, the dose could be adjusted by 3 μg, with dose increases implemented not more frequently than once every 2 days and dose decreases implemented per investigator's judgement. The minimum daily dose was 6 μg, and the maximum daily dose was 24 μg. Participants could be treated for a maximum of 20 days. Coasting, use of dopamine agonist or any other drug to prevent early OHSS with the exception of GnRH agonist for triggering of final follicular maturation, was not allowed. | | OG001 | Placebo | Placebo was administered as single daily subcutaneous injection dialed to the same value (dose) as FE 999049. Participants could be treated for a maximum of 20 days. Coasting, use of dopamine agonist or any other drug to prevent early OHSS with the exception of GnRH agonist for triggering of final follicular maturation, was not allowed. |
|
| Secondary | Proportion of Subjects With Treatment-induced Anti-FSH Antibodies, Overall as Well as With Neutralizing Capacity | Measured by presence of anti-FSH antibodies. 95% Clopper-Pearson confidence interval has been reported in this endpoint. | The safety analysis set comprised all randomized and exposed participants. Participants were analyzed according to actual treatment received. | Posted | | Number | 95% Confidence Interval | percentage of participants | | Up to 28 days after end of the stimulation period | | | | ID | Title | Description |
|---|
| OG000 | FE 999049 (Follitropin Delta) | FE 999049 was administered as single daily subcutaneous injections in the abdomen at a starting dose of 15 μg daily that was fixed for the first four stimulation days. Based on ovarian response, the dose could be adjusted by 3 μg, with dose increases implemented not more frequently than once every 2 days and dose decreases implemented per investigator's judgement. The minimum daily dose was 6 μg, and the maximum daily dose was 24 μg. Participants could be treated for a maximum of 20 days. Coasting, use of dopamine agonist or any other drug to prevent early OHSS with the exception of GnRH agonist for triggering of final follicular maturation, was not allowed. | | OG001 | Placebo | Placebo was administered as single daily subcutaneous injection dialed to the same value (dose) as FE 999049. Participants could be treated for a maximum of 20 days. Coasting, use of dopamine agonist or any other drug to prevent early OHSS with the exception of GnRH agonist for triggering of final follicular maturation, was not allowed. |
|
| Secondary | Frequency and Intensity of Immune-related Adverse Events | Standardised Medical Dictionary for Regulatory Activities (MedDRA) Queries (SMQs). | The safety analysis set comprised all randomized and exposed participants. Participants were analyzed according to actual treatment received. | Posted | | Number | | events | | From time of signing informed consent for participation in the trial until the end-of-cycle visit in the fresh cycle (approximately 6 months) | | | | ID | Title | Description |
|---|
| OG000 | FE 999049 (Follitropin Delta) | FE 999049 was administered as single daily subcutaneous injections in the abdomen at a starting dose of 15 μg daily that was fixed for the first four stimulation days. Based on ovarian response, the dose could be adjusted by 3 μg, with dose increases implemented not more frequently than once every 2 days and dose decreases implemented per investigator's judgement. The minimum daily dose was 6 μg, and the maximum daily dose was 24 μg. Participants could be treated for a maximum of 20 days. Coasting, use of dopamine agonist or any other drug to prevent early OHSS with the exception of GnRH agonist for triggering of final follicular maturation, was not allowed. | | OG001 | Placebo | Placebo was administered as single daily subcutaneous injection dialed to the same value (dose) as FE 999049. Participants could be treated for a maximum of 20 days. Coasting, use of dopamine agonist or any other drug to prevent early OHSS with the exception of GnRH agonist for triggering of final follicular maturation, was not allowed. |
|
| Secondary | Proportion of Subjects With Cycle Cancellations Due to an Adverse Event, Including Immune-related Adverse Events, or Due to Technical Malfunctions of the Administration Pen | For each participant the reason for cycle cancellation will be recorded. Data in this endpoint are presented for the fresh cycle. | The safety analysis set comprised all randomized and exposed participants. Participants were analyzed according to actual treatment received. | Posted | | Number | | percentage of participants | | Up to 20 stimulation days | | | | ID | Title | Description |
|---|
| OG000 | FE 999049 (Follitropin Delta) | FE 999049 was administered as single daily subcutaneous injections in the abdomen at a starting dose of 15 μg daily that was fixed for the first four stimulation days. Based on ovarian response, the dose could be adjusted by 3 μg, with dose increases implemented not more frequently than once every 2 days and dose decreases implemented per investigator's judgement. The minimum daily dose was 6 μg, and the maximum daily dose was 24 μg. Participants could be treated for a maximum of 20 days. Coasting, use of dopamine agonist or any other drug to prevent early OHSS with the exception of GnRH agonist for triggering of final follicular maturation, was not allowed. | | OG001 | Placebo | Placebo was administered as single daily subcutaneous injection dialed to the same value (dose) as FE 999049. Participants could be treated for a maximum of 20 days. Coasting, use of dopamine agonist or any other drug to prevent early OHSS with the exception of GnRH agonist for triggering of final follicular maturation, was not allowed. |
|
| Secondary | Proportion of Subjects With OHSS, Overall and by Grade, and Proportion of Subjects With Moderate/Severe OHSS | Classification of grade was according to Golan's classification system, and all OHSS cases were graded as mild, moderate or severe. Data in this endpoint are presented for the fresh cycle. | The safety analysis set comprised all randomized and exposed participants. Participants were analyzed according to actual treatment received. | Posted | | Number | | percentage of participants | | ≤9 days after triggering of final follicular maturation (early OHSS), >9 days after triggering of final follicular maturation until 21-28 days after last IMP dose or up to ongoing pregnancy 8-9 weeks after transfer in pregnant participants (late OHSS) | | | | ID | Title | Description |
|---|
| OG000 | FE 999049 (Follitropin Delta) | FE 999049 was administered as single daily subcutaneous injections in the abdomen at a starting dose of 15 μg daily that was fixed for the first four stimulation days. Based on ovarian response, the dose could be adjusted by 3 μg, with dose increases implemented not more frequently than once every 2 days and dose decreases implemented per investigator's judgement. The minimum daily dose was 6 μg, and the maximum daily dose was 24 μg. Participants could be treated for a maximum of 20 days. Coasting, use of dopamine agonist or any other drug to prevent early OHSS with the exception of GnRH agonist for triggering of final follicular maturation, was not allowed. | | OG001 | Placebo | |
|
| Secondary | Proportion of Subjects Hospitalized Due to OHSS and Proportion of Subjects Undergoing Paracentesis Due to OHSS | Percentage of participants hospitalized or undergoing paracentesis due to OHSS are reported | The safety analysis set comprised all randomized and exposed participants. Participants were analyzed according to actual treatment received. | Posted | | Number | | percentage of participants | | ≤9 days after triggering of final follicular maturation (early OHSS), >9 days after triggering of final follicular maturation until 21-28 days after last IMP dose or up to ongoing pregnancy 8-9 weeks after transfer in pregnant participants (late OHSS) | | | | ID | Title | Description |
|---|
| OG000 | FE 999049 (Follitropin Delta) | FE 999049 was administered as single daily subcutaneous injections in the abdomen at a starting dose of 15 μg daily that was fixed for the first four stimulation days. Based on ovarian response, the dose could be adjusted by 3 μg, with dose increases implemented not more frequently than once every 2 days and dose decreases implemented per investigator's judgement. The minimum daily dose was 6 μg, and the maximum daily dose was 24 μg. Participants could be treated for a maximum of 20 days. Coasting, use of dopamine agonist or any other drug to prevent early OHSS with the exception of GnRH agonist for triggering of final follicular maturation, was not allowed. | | OG001 | Placebo | Placebo was administered as single daily subcutaneous injection dialed to the same value (dose) as FE 999049. Participants could be treated for a maximum of 20 days. Coasting, use of dopamine agonist or any other drug to prevent early OHSS with the exception of GnRH agonist for triggering of final follicular maturation, was not allowed. |
|
| Secondary | Proportion of Participants With Multi-fetal Gestation in the Fresh Cycle | Defined as pregnancy with more than one fetus. Among participants with ongoing pregnancy, percentage of participants with twin pregnancies are presented. '%' in the unit of measure refers to 'percentage'. | The mITT analysis set comprised all randomized and exposed participants. Participants were analyzed according to planned treatment. | Posted | | Number | | % of participants with twin pregnancy | | Up to 8-9 weeks after transfer | | | | ID | Title | Description |
|---|
| OG000 | FE 999049 (Follitropin Delta) | FE 999049 was administered as single daily subcutaneous injections in the abdomen at a starting dose of 15 μg daily that was fixed for the first four stimulation days. Based on ovarian response, the dose could be adjusted by 3 μg, with dose increases implemented not more frequently than once every 2 days and dose decreases implemented per investigator's judgement. The minimum daily dose was 6 μg, and the maximum daily dose was 24 μg. Participants could be treated for a maximum of 20 days. Coasting, use of dopamine agonist or any other drug to prevent early OHSS with the exception of GnRH agonist for triggering of final follicular maturation, was not allowed. |
| |
| Secondary | Proportion of Cryopreserved Cycles With Multi-fetal Gestation | Defined as pregnancy with more than one fetus. Among cryopreserved cycles with ongoing pregnancy, percentage of cycles with twin pregnancies are presented. '%' in the unit of measure refers to 'percentage'. | The mITT analysis set comprised all randomized and exposed participants. Participants were analyzed according to planned treatment. | Posted | | Number | | % of cycles with twin pregnancy | | Up to 8-9 weeks after transfer | | | | ID | Title | Description |
|---|
| OG000 | FE 999049 (Follitropin Delta) | FE 999049 was administered as single daily subcutaneous injections in the abdomen at a starting dose of 15 μg daily that was fixed for the first four stimulation days. Based on ovarian response, the dose could be adjusted by 3 μg, with dose increases implemented not more frequently than once every 2 days and dose decreases implemented per investigator's judgement. The minimum daily dose was 6 μg, and the maximum daily dose was 24 μg. Participants could be treated for a maximum of 20 days. Coasting, use of dopamine agonist or any other drug to prevent early OHSS with the exception of GnRH agonist for triggering of final follicular maturation, was not allowed. |
| |
| Secondary | Biochemical Pregnancy, Spontaneous Abortion, Ectopic Pregnancy (With and Without Medical/Surgical Intervention) and Vanishing Twins in the Fresh Cycle | The percentage of participants with biochemical pregnancy, spontaneous abortion, ectopic pregnancy (with and without medical/surgical intervention) and vanishing twins in the fresh cycle are presented. Data represents participants with positive βhCG. Data is not shown for placebo arm because no participants had a positive βhCG. '%' in the unit of measure refers to 'percentage'. Unit: % of participants with early pregnancy loss. | The safety analysis set comprised all randomized and exposed participants. Participants were analyzed according to actual treatment received. | Posted | | Number | | % of participants | | Up to 8-9 weeks after transfer | | | | ID | Title | Description |
|---|
| OG000 | FE 999049 (Follitropin Delta) | FE 999049 was administered as single daily subcutaneous injections in the abdomen at a starting dose of 15 μg daily that was fixed for the first four stimulation days. Based on ovarian response, the dose could be adjusted by 3 μg, with dose increases implemented not more frequently than once every 2 days and dose decreases implemented per investigator's judgement. The minimum daily dose was 6 μg, and the maximum daily dose was 24 μg. Participants could be treated for a maximum of 20 days. Coasting, use of dopamine agonist or any other drug to prevent early OHSS with the exception of GnRH agonist for triggering of final follicular maturation, was not allowed. |
| |
| Secondary | Biochemical Pregnancy, Spontaneous Abortion, Ectopic Pregnancy (With and Without Medical/Surgical Intervention) and Vanishing Twins in the Cryopreserved Cycles | The percentage of cryopreserved cycles with biochemical pregnancy, spontaneous abortion, ectopic pregnancy (with and without medical/surgical intervention) and vanishing twins are presented. Data is not shown for placebo arm because no participants had a positive βhCG. '%' in the unit of measure refers to 'percentage'. | The safety analysis set comprised all randomized and exposed participants. Participants were analyzed according to actual treatment received. | Posted | | Number | | % of cycles with early pregnancy loss | | Up to 8-9 weeks after transfer | | | | ID | Title | Description |
|---|
| OG000 | FE 999049 (Follitropin Delta) | FE 999049 was administered as single daily subcutaneous injections in the abdomen at a starting dose of 15 μg daily that was fixed for the first four stimulation days. Based on ovarian response, the dose could be adjusted by 3 μg, with dose increases implemented not more frequently than once every 2 days and dose decreases implemented per investigator's judgement. The minimum daily dose was 6 μg, and the maximum daily dose was 24 μg. Participants could be treated for a maximum of 20 days. Coasting, use of dopamine agonist or any other drug to prevent early OHSS with the exception of GnRH agonist for triggering of final follicular maturation, was not allowed. |
| |
| Secondary | Proportion of Participants With Technical Malfunctions of the Administration Pen | Incidences of technical malfunctions of the administration pen were recorded. | The safety analysis set comprised all randomized and exposed participants. Participants were analyzed according to actual treatment received. | Posted | | Number | | percentage of participants | | Up to 20 stimulation days | | | | ID | Title | Description |
|---|
| OG000 | FE 999049 (Follitropin Delta) | FE 999049 was administered as single daily subcutaneous injections in the abdomen at a starting dose of 15 μg daily that was fixed for the first four stimulation days. Based on ovarian response, the dose could be adjusted by 3 μg, with dose increases implemented not more frequently than once every 2 days and dose decreases implemented per investigator's judgement. The minimum daily dose was 6 μg, and the maximum daily dose was 24 μg. Participants could be treated for a maximum of 20 days. Coasting, use of dopamine agonist or any other drug to prevent early OHSS with the exception of GnRH agonist for triggering of final follicular maturation, was not allowed. | | OG001 | Placebo | Placebo was administered as single daily subcutaneous injection dialed to the same value (dose) as FE 999049. Participants could be treated for a maximum of 20 days. Coasting, use of dopamine agonist or any other drug to prevent early OHSS with the exception of GnRH agonist for triggering of final follicular maturation, was not allowed. |
|