| Primary | Ongoing Pregnancy Rate | Defined as at least one intrauterine viable fetus 10-11 weeks after transfer. | The FAS was defined as all randomized and exposed participants. Participants were analyzed according to randomized treatment. | Posted | | Number | | percentage of participants | | 10-11 weeks after transfer | | | | ID | Title | Description |
|---|
| OG000 | FE 000049 (Follitropin Delta) | FE 999049 was administered as single daily subcutaneous injections in the abdomen. Participants randomized to FE 999049 had their individual dose determined on the basis of their AMH level at screening and their body weight at randomization. The daily FE 999049 dose was fixed throughout the stimulation period and minimum and maximum allowed daily dose was 6 and 12 μg, respectively. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days. | | OG001 | GONAL-F (Follitropin Alfa) | GONAL-F was administered as single daily subcutaneous injections in the abdomen. The starting dose of GONAL-F was 150 IU and fixed for the first five stimulation days, after which it could be adjusted by 75 IU based on the individual response. The maximum allowed daily dose was 450 IU. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days. |
| | | Title | Denominators | Categories |
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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 |
|---|
| Percentage of participants with ongoing pregnancy rate | | | | | Risk Difference (RD) | 5.4 | | | 2-Sided | 95 | -0.2 | 11.0 | | | The difference (FE 999049 - GONAL-F) in rates was estimated and a two-sided 95% Cl was constructed using the Mantel-Haenszel method to combine results across age strata. | | Non-Inferiority | If the lower-limit of the two-sided 95% confidence interval (CI) was greater than the non-inferiority limit (-10.0%), the null hypothesis was rejected. In that case, it would be claimed that FE 999049 was non-inferior to GONAL-F with respect to ongoing pregnancy rate in women undergoing controlled ovarian stimulation. |
|
| Secondary | Positive Beta Unit of Human Chorionic Gonadotropin (βhCG) Rate | Defined as positive βhCG test 13-15 days after transfer. | The FAS was defined as all randomized and exposed participants. Participants were analyzed according to randomized treatment. | Posted | | Number | | percentage of participants | | 13-15 days after transfer | | | | ID | Title | Description |
|---|
| OG000 | FE 000049 (Follitropin Delta) | FE 999049 was administered as single daily subcutaneous injections in the abdomen. Participants randomized to FE 999049 had their individual dose determined on the basis of their AMH level at screening and their body weight at randomization. The daily FE 999049 dose was fixed throughout the stimulation period and minimum and maximum allowed daily dose was 6 and 12 μg, respectively. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days. | | OG001 | GONAL-F (Follitropin Alfa) | GONAL-F was administered as single daily subcutaneous injections in the abdomen. The starting dose of GONAL-F was 150 IU and fixed for the first five stimulation days, after which it could be adjusted by 75 IU based on the individual response. The maximum allowed daily dose was 450 IU. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days. |
| |
| Secondary | Clinical Pregnancy Rate | Defined as at least one gestational sac 5-6 weeks after transfer. | The FAS was defined as all randomized and exposed participants. Participants were analyzed according to randomized treatment. | Posted | | Number | | percentage of participants | | 5-6 weeks after transfer | | | | ID | Title | Description |
|---|
| OG000 | FE 000049 (Follitropin Delta) | FE 999049 was administered as single daily subcutaneous injections in the abdomen. Participants randomized to FE 999049 had their individual dose determined on the basis of their AMH level at screening and their body weight at randomization. The daily FE 999049 dose was fixed throughout the stimulation period and minimum and maximum allowed daily dose was 6 and 12 μg, respectively. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days. | | OG001 | GONAL-F (Follitropin Alfa) | GONAL-F was administered as single daily subcutaneous injections in the abdomen. The starting dose of GONAL-F was 150 IU and fixed for the first five stimulation days, after which it could be adjusted by 75 IU based on the individual response. The maximum allowed daily dose was 450 IU. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days. |
| |
| Secondary | Vital Pregnancy Rate | Defined as at least one intrauterine gestational sac with fetal heart beat 5-6 weeks after transfer. | The FAS was defined as all randomized and exposed participants. Participants were analyzed according to randomized treatment. | Posted | | Number | | percentage of participants | | 5-6 weeks after transfer | | | | ID | Title | Description |
|---|
| OG000 | FE 000049 (Follitropin Delta) | FE 999049 was administered as single daily subcutaneous injections in the abdomen. Participants randomized to FE 999049 had their individual dose determined on the basis of their AMH level at screening and their body weight at randomization. The daily FE 999049 dose was fixed throughout the stimulation period and minimum and maximum allowed daily dose was 6 and 12 μg, respectively. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days. | | OG001 | GONAL-F (Follitropin Alfa) | GONAL-F was administered as single daily subcutaneous injections in the abdomen. The starting dose of GONAL-F was 150 IU and fixed for the first five stimulation days, after which it could be adjusted by 75 IU based on the individual response. The maximum allowed daily dose was 450 IU. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days. |
| |
| Secondary | Implantation Rate | Defined as number of gestational sacs 5-6 weeks after transfer divided by number of embryos transferred. | Participants with embryo transfer (a total of 548 and 546 embryos were transferred in the FE 999049 and GONAL-F groups, respectively). The experimental unit was transferred embryo. | Posted | | Number | | percentage of sacs/embryos transferred | | 5-6 weeks after transfer | Embryos transferred | Embryos transferred | | ID | Title | Description |
|---|
| OG000 | FE 000049 (Follitropin Delta) | FE 999049 was administered as single daily subcutaneous injections in the abdomen. Participants randomized to FE 999049 had their individual dose determined on the basis of their AMH level at screening and their body weight at randomization. The daily FE 999049 dose was fixed throughout the stimulation period and minimum and maximum allowed daily dose was 6 and 12 μg, respectively. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days. | | OG001 | GONAL-F (Follitropin Alfa) | GONAL-F was administered as single daily subcutaneous injections in the abdomen. The starting dose of GONAL-F was 150 IU and fixed for the first five stimulation days, after which it could be adjusted by 75 IU based on the individual response. The maximum allowed daily dose was 450 IU. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days. |
|
| Secondary | Ongoing Implantation Rate | Defined as number of intrauterine viable fetuses 10-11 weeks after transfer divided by number of embryos transferred. | Participants with embryo transfer (a total of 548 and 546 embryos were transferred in the FE 999049 and GONAL-F groups, respectively). The experimental unit was transferred embryos. | Posted | | Number | | % of viable fetus/embryos transferred | | 10-11 weeks after transfer | Embryos transferred | Embryos transferred | | ID | Title | Description |
|---|
| OG000 | FE 000049 (Follitropin Delta) | FE 999049 was administered as single daily subcutaneous injections in the abdomen. Participants randomized to FE 999049 had their individual dose determined on the basis of their AMH level at screening and their body weight at randomization. The daily FE 999049 dose was fixed throughout the stimulation period and minimum and maximum allowed daily dose was 6 and 12 μg, respectively. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days. | | OG001 | GONAL-F (Follitropin Alfa) | GONAL-F was administered as single daily subcutaneous injections in the abdomen. The starting dose of GONAL-F was 150 IU and fixed for the first five stimulation days, after which it could be adjusted by 75 IU based on the individual response. The maximum allowed daily dose was 450 IU. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days. |
|
| Secondary | Proportion of Subjects With Extreme Ovarian Responses | Extreme ovarian response defined as <4, ≥15 or ≥ 20 oocytes retrieved. Participants with cycle cancellation due to poor ovarian response are included as <4 oocytes retrieved. | The FAS was defined as all randomized and exposed participants. Participants analyzed for this endpoint represent participants with oocytes retrieved and participants with cycle cancellation due to poor ovarian response. | Posted | | Number | | percentage of participants | | Oocyte retrieval visit | | | | ID | Title | Description |
|---|
| OG000 | FE 000049 (Follitropin Delta) | FE 999049 was administered as single daily subcutaneous injections in the abdomen. Participants randomized to FE 999049 had their individual dose determined on the basis of their AMH level at screening and their body weight at randomization. The daily FE 999049 dose was fixed throughout the stimulation period and minimum and maximum allowed daily dose was 6 and 12 μg, respectively. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days. | | OG001 | GONAL-F (Follitropin Alfa) | GONAL-F was administered as single daily subcutaneous injections in the abdomen. The starting dose of GONAL-F was 150 IU and fixed for the first five stimulation days, after which it could be adjusted by 75 IU based on the individual response. The maximum allowed daily dose was 450 IU. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days. |
|
| Secondary | Proportion of Subjects With Early OHSS (Including OHSS of Moderate/Severe Grade) and/or Preventive Interventions for Early OHSS | Early OHSS was defined as OHSS with onset ≤9 days after triggering of final follicular maturation. Classification of grade was according to Golan's classification system, and all OHSS cases were graded as mild, moderate or severe. | The safety analysis set was defined as all randomized and exposed participants. Participants were analyzed according to actual treatment received. | Posted | | Number | | percentage of participants | | Up to 9 days after triggering of final follicular maturation | | | | ID | Title | Description |
|---|
| OG000 | FE 000049 (Follitropin Delta) | FE 999049 was administered as single daily subcutaneous injections in the abdomen. Participants randomized to FE 999049 had their individual dose determined on the basis of their AMH level at screening and their body weight at randomization. The daily FE 999049 dose was fixed throughout the stimulation period and minimum and maximum allowed daily dose was 6 and 12 μg, respectively. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days. | | OG001 | GONAL-F (Follitropin Alfa) | GONAL-F was administered as single daily subcutaneous injections in the abdomen. The starting dose of GONAL-F was 150 IU and fixed for the first five stimulation days, after which it could be adjusted by 75 IU based on the individual response. The maximum allowed daily dose was 450 IU. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days. |
|
| Secondary | Proportion of Subjects With Cycle Cancellation Due to Poor or Excessive Ovarian Response or Embryo Transfer Cancellation Due to Excessive Ovarian Response / OHSS Risk | For each participant the reason for each cycle cancellation was recorded. Embryo transfer cancellation due to adverse events, such as ovarian hyperfunction, OHSS and progesterone increased in participants with embryos available for transfer, were considered as transfer cancellations due to excessive response / OHSS risk. | The FAS was defined as all randomized and exposed participants. Participants were analyzed according to randomized treatment. | Posted | | Number | | percentage of participants | | End-of-stimulation visit (up to 20 days) or transfer visit | | | | ID | Title | Description |
|---|
| OG000 | FE 000049 (Follitropin Delta) | FE 999049 was administered as single daily subcutaneous injections in the abdomen. Participants randomized to FE 999049 had their individual dose determined on the basis of their AMH level at screening and their body weight at randomization. The daily FE 999049 dose was fixed throughout the stimulation period and minimum and maximum allowed daily dose was 6 and 12 μg, respectively. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days. | | OG001 | GONAL-F (Follitropin Alfa) | GONAL-F was administered as single daily subcutaneous injections in the abdomen. The starting dose of GONAL-F was 150 IU and fixed for the first five stimulation days, after which it could be adjusted by 75 IU based on the individual response. The maximum allowed daily dose was 450 IU. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days. |
|
| Secondary | Number of Follicles on Stimulation Day 6 | Counted by ultrasound for the right and left ovary for each participant. | The FAS was defined as all randomized and exposed participants. Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure. | Posted | | Mean | Standard Deviation | number of follicles | | On stimulation Day 6 | | | | ID | Title | Description |
|---|
| OG000 | FE 000049 (Follitropin Delta) | FE 999049 was administered as single daily subcutaneous injections in the abdomen. Participants randomized to FE 999049 had their individual dose determined on the basis of their AMH level at screening and their body weight at randomization. The daily FE 999049 dose was fixed throughout the stimulation period and minimum and maximum allowed daily dose was 6 and 12 μg, respectively. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days. | | OG001 | GONAL-F (Follitropin Alfa) | GONAL-F was administered as single daily subcutaneous injections in the abdomen. The starting dose of GONAL-F was 150 IU and fixed for the first five stimulation days, after which it could be adjusted by 75 IU based on the individual response. The maximum allowed daily dose was 450 IU. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days. |
|
| Secondary | Number of Follicles At End-of-stimulation (up to 20 Stimulation Days) | Counted by ultrasound for the right and left ovary for each participant. | The FAS was defined as all randomized and exposed participants. Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure. | Posted | | Mean | Standard Deviation | number of follicles | | At end-of-stimulation (up to 20 stimulation days) | | | | ID | Title | Description |
|---|
| OG000 | FE 000049 (Follitropin Delta) | FE 999049 was administered as single daily subcutaneous injections in the abdomen. Participants randomized to FE 999049 had their individual dose determined on the basis of their AMH level at screening and their body weight at randomization. The daily FE 999049 dose was fixed throughout the stimulation period and minimum and maximum allowed daily dose was 6 and 12 μg, respectively. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days. | | OG001 | GONAL-F (Follitropin Alfa) | GONAL-F was administered as single daily subcutaneous injections in the abdomen. The starting dose of GONAL-F was 150 IU and fixed for the first five stimulation days, after which it could be adjusted by 75 IU based on the individual response. The maximum allowed daily dose was 450 IU. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days. |
|
| Secondary | Size of Follicles on Stimulation Day 6 | Counted by ultrasound for the right and left ovary for each participant. | The FAS was defined as all randomized and exposed participants. Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure. | Posted | | Mean | Standard Deviation | mm | | On stimulation Day 6 | | | | ID | Title | Description |
|---|
| OG000 | FE 000049 (Follitropin Delta) | FE 999049 was administered as single daily subcutaneous injections in the abdomen. Participants randomized to FE 999049 had their individual dose determined on the basis of their AMH level at screening and their body weight at randomization. The daily FE 999049 dose was fixed throughout the stimulation period and minimum and maximum allowed daily dose was 6 and 12 μg, respectively. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days. | | OG001 | GONAL-F (Follitropin Alfa) | GONAL-F was administered as single daily subcutaneous injections in the abdomen. The starting dose of GONAL-F was 150 IU and fixed for the first five stimulation days, after which it could be adjusted by 75 IU based on the individual response. The maximum allowed daily dose was 450 IU. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days. |
|
| Secondary | Size of Follicles At End-of-stimulation (up to 20 Stimulation Days) | Counted by ultrasound for the right and left ovary for each participant. | The FAS was defined as all randomized and exposed participants. Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure. | Posted | | Mean | Standard Deviation | mm | | At end-of-stimulation (up to 20 stimulation days) | | | | ID | Title | Description |
|---|
| OG000 | FE 000049 (Follitropin Delta) | FE 999049 was administered as single daily subcutaneous injections in the abdomen. Participants randomized to FE 999049 had their individual dose determined on the basis of their AMH level at screening and their body weight at randomization. The daily FE 999049 dose was fixed throughout the stimulation period and minimum and maximum allowed daily dose was 6 and 12 μg, respectively. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days. | | OG001 | GONAL-F (Follitropin Alfa) | GONAL-F was administered as single daily subcutaneous injections in the abdomen. The starting dose of GONAL-F was 150 IU and fixed for the first five stimulation days, after which it could be adjusted by 75 IU based on the individual response. The maximum allowed daily dose was 450 IU. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days. |
|
| Secondary | Number of Oocytes Retrieved | The number of oocytes retrieved was recorded at the oocyte retrieval visit. | The FAS was defined as all randomized and exposed participants. Participants were analyzed according to randomized treatment. | Posted | | Mean | Standard Deviation | oocytes retrieved | | On the day of oocyte retrieval (36 h [±2h] after triggering of final follicular maturation) | | | | ID | Title | Description |
|---|
| OG000 | FE 000049 (Follitropin Delta) | FE 999049 was administered as single daily subcutaneous injections in the abdomen. Participants randomized to FE 999049 had their individual dose determined on the basis of their AMH level at screening and their body weight at randomization. The daily FE 999049 dose was fixed throughout the stimulation period and minimum and maximum allowed daily dose was 6 and 12 μg, respectively. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days. | | OG001 | GONAL-F (Follitropin Alfa) | GONAL-F was administered as single daily subcutaneous injections in the abdomen. The starting dose of GONAL-F was 150 IU and fixed for the first five stimulation days, after which it could be adjusted by 75 IU based on the individual response. The maximum allowed daily dose was 450 IU. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days. |
|
| 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 FAS was defined as all randomized and exposed participants. Participants analyzed for this endpoint represent participants with oocytes retrieved and participants with cycle cancellation due to poor ovarian response. | Posted | | Number | | percentage of participants | | On the day of oocyte retrieval | | | | ID | Title | Description |
|---|
| OG000 | FE 000049 (Follitropin Delta) | FE 999049 was administered as single daily subcutaneous injections in the abdomen. Participants randomized to FE 999049 had their individual dose determined on the basis of their AMH level at screening and their body weight at randomization. The daily FE 999049 dose was fixed throughout the stimulation period and minimum and maximum allowed daily dose was 6 and 12 μg, respectively. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days. | | OG001 | GONAL-F (Follitropin Alfa) | GONAL-F was administered as single daily subcutaneous injections in the abdomen. The starting dose of GONAL-F was 150 IU and fixed for the first five stimulation days, after which it could be adjusted by 75 IU based on the individual response. The maximum allowed daily dose was 450 IU. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days |
|
| Secondary | Percentage of Metaphase II (MII) Oocytes | The percentage of MII oocytes to oocytes retrieved for participants where all oocytes were inseminated using intracytoplasmic sperm injection (ICSI) are presented. | The FAS was defined as all randomized and exposed participants. Participants analyzed for this endpoint represent participants with all oocytes inseminated using ICSI. | Posted | | Mean | Standard Deviation | percentage of oocytes | | Prior to insemination | | | | ID | Title | Description |
|---|
| OG000 | FE 000049 (Follitropin Delta) | FE 999049 was administered as single daily subcutaneous injections in the abdomen. Participants randomized to FE 999049 had their individual dose determined on the basis of their AMH level at screening and their body weight at randomization. The daily FE 999049 dose was fixed throughout the stimulation period and minimum and maximum allowed daily dose was 6 and 12 μg, respectively. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days. | | OG001 | GONAL-F (Follitropin Alfa) | GONAL-F was administered as single daily subcutaneous injections in the abdomen. The starting dose of GONAL-F was 150 IU and fixed for the first five stimulation days, after which it could be adjusted by 75 IU based on the individual response. The maximum allowed daily dose was 450 IU. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days. |
|
| Secondary | Fertilization Rate | The fertilization rate was defined as the number of oocytes with 2 pronuclei divided by the number of oocytes retrieved. | Participants with oocytes retrieved. | Posted | | Mean | Standard Deviation | percentage of fertilized oocytes | | On Day 1 after oocyte retrieval | | | | ID | Title | Description |
|---|
| OG000 | FE 000049 (Follitropin Delta) | FE 999049 was administered as single daily subcutaneous injections in the abdomen. Participants randomized to FE 999049 had their individual dose determined on the basis of their AMH level at screening and their body weight at randomization. The daily FE 999049 dose was fixed throughout the stimulation period and minimum and maximum allowed daily dose was 6 and 12 μg, respectively. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days. | | OG001 | GONAL-F (Follitropin Alfa) | GONAL-F was administered as single daily subcutaneous injections in the abdomen. The starting dose of GONAL-F was 150 IU and fixed for the first five stimulation days, after which it could be adjusted by 75 IU based on the individual response. The maximum allowed daily dose was 450 IU. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days. |
| |
| Secondary | Number and Quality of Embryos | Number of embryos (total and good-quality) on Day 3 are presented. A good-quality embryo was defined as an embryo with ≥6 blastomeres and ≤20% fragmentation, without signs of multinucleation. | The FAS was defined as all randomized and exposed participants. Participants were analyzed according to randomized treatment. | Posted | | Mean | Standard Deviation | embryos | | On Day 3 after oocyte retrieval | | | | ID | Title | Description |
|---|
| OG000 | FE 000049 (Follitropin Delta) | FE 999049 was administered as single daily subcutaneous injections in the abdomen. Participants randomized to FE 999049 had their individual dose determined on the basis of their AMH level at screening and their body weight at randomization. The daily FE 999049 dose was fixed throughout the stimulation period and minimum and maximum allowed daily dose was 6 and 12 μg, respectively. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days. | | OG001 | GONAL-F (Follitropin Alfa) | GONAL-F was administered as single daily subcutaneous injections in the abdomen. The starting dose of GONAL-F was 150 IU and fixed for the first five stimulation days, after which it could be adjusted by 75 IU based on the individual response. The maximum allowed daily dose was 450 IU. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days. |
|
| Secondary | Circulating Concentrations of Luteinizing Hormone (LH) | Blood samples for analysis of circulating concentrations of LH were drawn. The median and inter-quartile range (IQR) of LH levels on stimulation Day 6 are presented. | The FAS was defined as all randomized and exposed participants. Participants were analyzed according to randomized treatment. | Posted | | Median | Inter-Quartile Range | IU/L | | On stimulation Day 6 | | | | ID | Title | Description |
|---|
| OG000 | FE 000049 (Follitropin Delta) | FE 999049 was administered as single daily subcutaneous injections in the abdomen. Participants randomized to FE 999049 had their individual dose determined on the basis of their AMH level at screening and their body weight at randomization. The daily FE 999049 dose was fixed throughout the stimulation period and minimum and maximum allowed daily dose was 6 and 12 μg, respectively. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days. | | OG001 | GONAL-F (Follitropin Alfa) | GONAL-F was administered as single daily subcutaneous injections in the abdomen. The starting dose of GONAL-F was 150 IU and fixed for the first five stimulation days, after which it could be adjusted by 75 IU based on the individual response. The maximum allowed daily dose was 450 IU. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days. |
|
| Secondary | Circulating Concentrations of LH | Blood samples for analysis of circulating concentrations of LH were drawn. The median and IQR of LH levels at end-of-stimulation are presented. | The FAS was defined as all randomized and exposed participants. Participants were analyzed according to randomized treatment. | Posted | | Median | Inter-Quartile Range | IU/L | | End-of-stimulation (up to 20 stimulation days) | | | | ID | Title | Description |
|---|
| OG000 | FE 000049 (Follitropin Delta) | FE 999049 was administered as single daily subcutaneous injections in the abdomen. Participants randomized to FE 999049 had their individual dose determined on the basis of their AMH level at screening and their body weight at randomization. The daily FE 999049 dose was fixed throughout the stimulation period and minimum and maximum allowed daily dose was 6 and 12 μg, respectively. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days. | | OG001 | GONAL-F (Follitropin Alfa) | GONAL-F was administered as single daily subcutaneous injections in the abdomen. The starting dose of GONAL-F was 150 IU and fixed for the first five stimulation days, after which it could be adjusted by 75 IU based on the individual response. The maximum allowed daily dose was 450 IU. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days. |
|
| 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 6 are presented. | The FAS was defined as all randomized and exposed participants. Participants were analyzed according to randomized treatment. | Posted | | Median | Inter-Quartile Range | pmol/L | | On stimulation Day 6 | | | | ID | Title | Description |
|---|
| OG000 | FE 000049 (Follitropin Delta) | FE 999049 was administered as single daily subcutaneous injections in the abdomen. Participants randomized to FE 999049 had their individual dose determined on the basis of their AMH level at screening and their body weight at randomization. The daily FE 999049 dose was fixed throughout the stimulation period and minimum and maximum allowed daily dose was 6 and 12 μg, respectively. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days. | | OG001 | GONAL-F (Follitropin Alfa) | GONAL-F was administered as single daily subcutaneous injections in the abdomen. The starting dose of GONAL-F was 150 IU and fixed for the first five stimulation days, after which it could be adjusted by 75 IU based on the individual response. The maximum allowed daily dose was 450 IU. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days |
|
| Secondary | Circulating Concentrations of Estradiol | Blood samples for analysis of circulating concentrations of estradiol were drawn. The median and IQR of estradiol levels at end-of-stimulation are presented. | The FAS was defined as all randomized and exposed participants. Participants were analyzed according to randomized treatment. | Posted | | Median | Inter-Quartile Range | pmol/L | | End-of-stimulation (up to 20 stimulation days) | | | | ID | Title | Description |
|---|
| OG000 | FE 000049 (Follitropin Delta) | FE 999049 was administered as single daily subcutaneous injections in the abdomen. Participants randomized to FE 999049 had their individual dose determined on the basis of their AMH level at screening and their body weight at randomization. The daily FE 999049 dose was fixed throughout the stimulation period and minimum and maximum allowed daily dose was 6 and 12 μg, respectively. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days. | | OG001 | GONAL-F (Follitropin Alfa) | GONAL-F was administered as single daily subcutaneous injections in the abdomen. The starting dose of GONAL-F was 150 IU and fixed for the first five stimulation days, after which it could be adjusted by 75 IU based on the individual response. The maximum allowed daily dose was 450 IU. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days |
|
| 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 6 are presented. | The FAS was defined as all randomized and exposed participants. Participants were analyzed according to randomized treatment. | Posted | | Median | Inter-Quartile Range | nmol/L | | On stimulation Day 6 | | | | ID | Title | Description |
|---|
| OG000 | FE 000049 (Follitropin Delta) | FE 999049 was administered as single daily subcutaneous injections in the abdomen. Participants randomized to FE 999049 had their individual dose determined on the basis of their AMH level at screening and their body weight at randomization. The daily FE 999049 dose was fixed throughout the stimulation period and minimum and maximum allowed daily dose was 6 and 12 μg, respectively. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days. | | OG001 | GONAL-F (Follitropin Alfa) | GONAL-F was administered as single daily subcutaneous injections in the abdomen. The starting dose of GONAL-F was 150 IU and fixed for the first five stimulation days, after which it could be adjusted by 75 IU based on the individual response. The maximum allowed daily dose was 450 IU. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days |
|
| Secondary | Circulating Concentrations of Progesterone | Blood samples for analysis of circulating concentrations of progesterone were drawn. The median and IQR of progesterone levels at end-of-stimulation are presented. | The FAS was defined as all randomized and exposed participants. Participants were analyzed according to randomized treatment. | Posted | | Median | Inter-Quartile Range | nmol/L | | End-of-stimulation (up to 20 stimulation days) | | | | ID | Title | Description |
|---|
| OG000 | FE 000049 (Follitropin Delta) | FE 999049 was administered as single daily subcutaneous injections in the abdomen. Participants randomized to FE 999049 had their individual dose determined on the basis of their AMH level at screening and their body weight at randomization. The daily FE 999049 dose was fixed throughout the stimulation period and minimum and maximum allowed daily dose was 6 and 12 μg, respectively. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days. | | OG001 | GONAL-F (Follitropin Alfa) | GONAL-F was administered as single daily subcutaneous injections in the abdomen. The starting dose of GONAL-F was 150 IU and fixed for the first five stimulation days, after which it could be adjusted by 75 IU based on the individual response. The maximum allowed daily dose was 450 IU. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days |
|
| Secondary | Circulating Concentrations of Inhibin A | Blood samples for analysis of circulating concentrations of inhibin A. The median and IQR of inhibin A levels on stimulation Day 6 are presented. | The FAS was defined as all randomized and exposed participants. Participants were analyzed according to randomized treatment. | Posted | | Median | Inter-Quartile Range | ng/L | | On stimulation Day 6 | | | | ID | Title | Description |
|---|
| OG000 | FE 000049 (Follitropin Delta) | FE 999049 was administered as single daily subcutaneous injections in the abdomen. Participants randomized to FE 999049 had their individual dose determined on the basis of their AMH level at screening and their body weight at randomization. The daily FE 999049 dose was fixed throughout the stimulation period and minimum and maximum allowed daily dose was 6 and 12 μg, respectively. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days. | | OG001 | GONAL-F (Follitropin Alfa) | GONAL-F was administered as single daily subcutaneous injections in the abdomen. The starting dose of GONAL-F was 150 IU and fixed for the first five stimulation days, after which it could be adjusted by 75 IU based on the individual response. The maximum allowed daily dose was 450 IU. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days |
|
| 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 at end-of-stimulation are presented. | The FAS was defined as all randomized and exposed participants. Participants were analyzed according to randomized treatment. | Posted | | Median | Inter-Quartile Range | ng/L | | End-of-stimulation (up to 20 stimulation days) | | | | ID | Title | Description |
|---|
| OG000 | FE 000049 (Follitropin Delta) | FE 999049 was administered as single daily subcutaneous injections in the abdomen. Participants randomized to FE 999049 had their individual dose determined on the basis of their AMH level at screening and their body weight at randomization. The daily FE 999049 dose was fixed throughout the stimulation period and minimum and maximum allowed daily dose was 6 and 12 μg, respectively. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days. | | OG001 | GONAL-F (Follitropin Alfa) | GONAL-F was administered as single daily subcutaneous injections in the abdomen. The starting dose of GONAL-F was 150 IU and fixed for the first five stimulation days, after which it could be adjusted by 75 IU based on the individual response. The maximum allowed daily dose was 450 IU. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days |
|
| 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 6 are presented. | The FAS was defined as all randomized and exposed participants. Participants were analyzed according to randomized treatment. | Posted | | Median | Inter-Quartile Range | ng/L | | On stimulation Day 6 | | | | ID | Title | Description |
|---|
| OG000 | FE 000049 (Follitropin Delta) | FE 999049 was administered as single daily subcutaneous injections in the abdomen. Participants randomized to FE 999049 had their individual dose determined on the basis of their AMH level at screening and their body weight at randomization. The daily FE 999049 dose was fixed throughout the stimulation period and minimum and maximum allowed daily dose was 6 and 12 μg, respectively. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days. | | OG001 | GONAL-F (Follitropin Alfa) | GONAL-F was administered as single daily subcutaneous injections in the abdomen. The starting dose of GONAL-F was 150 IU and fixed for the first five stimulation days, after which it could be adjusted by 75 IU based on the individual response. The maximum allowed daily dose was 450 IU. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days |
|
| 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 at end-of-stimulation are presented. | The FAS was defined as all randomized and exposed participants. Participants were analyzed according to randomized treatment. | Posted | | Median | Inter-Quartile Range | ng/L | | End-of-stimulation (up to 20 stimulation days) | | | | ID | Title | Description |
|---|
| OG000 | FE 000049 (Follitropin Delta) | FE 999049 was administered as single daily subcutaneous injections in the abdomen. Participants randomized to FE 999049 had their individual dose determined on the basis of their AMH level at screening and their body weight at randomization. The daily FE 999049 dose was fixed throughout the stimulation period and minimum and maximum allowed daily dose was 6 and 12 μg, respectively. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days. | | OG001 | GONAL-F (Follitropin Alfa) | GONAL-F was administered as single daily subcutaneous injections in the abdomen. The starting dose of GONAL-F was 150 IU and fixed for the first five stimulation days, after which it could be adjusted by 75 IU based on the individual response. The maximum allowed daily dose was 450 IU. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days |
|
| 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 6 are presented. | The FAS was defined as all randomized and exposed participants. Participants were analyzed according to randomized treatment. | Posted | | Median | Inter-Quartile Range | IU/L | | On stimulation Day 6 | | | | ID | Title | Description |
|---|
| OG000 | FE 000049 (Follitropin Delta) | FE 999049 was administered as single daily subcutaneous injections in the abdomen. Participants randomized to FE 999049 had their individual dose determined on the basis of their AMH level at screening and their body weight at randomization. The daily FE 999049 dose was fixed throughout the stimulation period and minimum and maximum allowed daily dose was 6 and 12 μg, respectively. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days. | | OG001 | GONAL-F (Follitropin Alfa) | GONAL-F was administered as single daily subcutaneous injections in the abdomen. The starting dose of GONAL-F was 150 IU and fixed for the first five stimulation days, after which it could be adjusted by 75 IU based on the individual response. The maximum allowed daily dose was 450 IU. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days |
|
| Secondary | Circulating Concentrations of FSH | Blood samples for analysis of circulating concentrations of FSH were drawn. The median and IQR of FSH levels at end-of-stimulation are presented. | The FAS was defined as all randomized and exposed participants. Participants were analyzed according to randomized treatment. | Posted | | Median | Inter-Quartile Range | IU/L | | End-of-stimulation (up to 20 stimulation days) | | | | ID | Title | Description |
|---|
| OG000 | FE 000049 (Follitropin Delta) | FE 999049 was administered as single daily subcutaneous injections in the abdomen. Participants randomized to FE 999049 had their individual dose determined on the basis of their AMH level at screening and their body weight at randomization. The daily FE 999049 dose was fixed throughout the stimulation period and minimum and maximum allowed daily dose was 6 and 12 μg, respectively. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days. | | OG001 | GONAL-F (Follitropin Alfa) | GONAL-F was administered as single daily subcutaneous injections in the abdomen. The starting dose of GONAL-F was 150 IU and fixed for the first five stimulation days, after which it could be adjusted by 75 IU based on the individual response. The maximum allowed daily dose was 450 IU. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days |
|
| Secondary | Circulating Concentrations of FSH | Blood samples for analysis of circulating concentrations of FSH were drawn. The median and IQR of FSH levels at oocyte retrieval are presented. | The FAS was defined as all randomized and exposed participants. Participants were analyzed according to randomized treatment. | Posted | | Median | Inter-Quartile Range | IU/L | | At oocyte retrieval | | | | ID | Title | Description |
|---|
| OG000 | FE 000049 (Follitropin Delta) | FE 999049 was administered as single daily subcutaneous injections in the abdomen. Participants randomized to FE 999049 had their individual dose determined on the basis of their AMH level at screening and their body weight at randomization. The daily FE 999049 dose was fixed throughout the stimulation period and minimum and maximum allowed daily dose was 6 and 12 μg, respectively. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days. | | OG001 | GONAL-F (Follitropin Alfa) | GONAL-F was administered as single daily subcutaneous injections in the abdomen. The starting dose of GONAL-F was 150 IU and fixed for the first five stimulation days, after which it could be adjusted by 75 IU based on the individual response. The maximum allowed daily dose was 450 IU. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days |
|
| Secondary | Total Gonadotropin Dose | Calculated by start dates, end dates and daily dose of IMP. | The FAS was defined as all randomized and exposed participants. Participants were analyzed according to randomized treatment. | Posted | | Mean | Standard Deviation | microgram of dose | | Up to 20 stimulation days | | | | ID | Title | Description |
|---|
| OG000 | FE 000049 (Follitropin Delta) | FE 999049 was administered as single daily subcutaneous injections in the abdomen. Participants randomized to FE 999049 had their individual dose determined on the basis of their AMH level at screening and their body weight at randomization. The daily FE 999049 dose was fixed throughout the stimulation period and minimum and maximum allowed daily dose was 6 and 12 μg, respectively. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days. | | OG001 | GONAL-F (Follitropin Alfa) | GONAL-F was administered as single daily subcutaneous injections in the abdomen. The starting dose of GONAL-F was 150 IU and fixed for the first five stimulation days, after which it could be adjusted by 75 IU based on the individual response. The maximum allowed daily dose was 450 IU. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days. |
| |
| Secondary | Proportion of Subjects With Investigator-requested Gonadotropin Dose Adjustments | Investigator-requested decreases and increases of the gonadotropin dose were captured during the stimulation period. | The FAS was defined as all randomized and exposed participants. Participants were analyzed according to randomized treatment. | Posted | | Number | | percentage of participants | | Up to 20 stimulation days | | | | ID | Title | Description |
|---|
| OG000 | FE 000049 (Follitropin Delta) | FE 999049 was administered as single daily subcutaneous injections in the abdomen. Participants randomized to FE 999049 had their individual dose determined on the basis of their AMH level at screening and their body weight at randomization. The daily FE 999049 dose was fixed throughout the stimulation period and minimum and maximum allowed daily dose was 6 and 12 μg, respectively. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days. | | OG001 | GONAL-F (Follitropin Alfa) | GONAL-F was administered as single daily subcutaneous injections in the abdomen. The starting dose of GONAL-F was 150 IU and fixed for the first five stimulation days, after which it could be adjusted by 75 IU based on the individual response. The maximum allowed daily dose was 450 IU. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days. |
|
| Secondary | Number of Stimulation Days | Calculated by start dates and end dates. | The FAS was defined as all randomized and exposed participants. Participants were analyzed according to randomized treatment. | Posted | | Mean | Standard Deviation | days | | Up to 20 stimulation days | | | | ID | Title | Description |
|---|
| OG000 | FE 000049 (Follitropin Delta) | FE 999049 was administered as single daily subcutaneous injections in the abdomen. Participants randomized to FE 999049 had their individual dose determined on the basis of their AMH level at screening and their body weight at randomization. The daily FE 999049 dose was fixed throughout the stimulation period and minimum and maximum allowed daily dose was 6 and 12 μg, respectively. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days. | | OG001 | GONAL-F (Follitropin Alfa) | GONAL-F was administered as single daily subcutaneous injections in the abdomen. The starting dose of GONAL-F was 150 IU and fixed for the first five stimulation days, after which it could be adjusted by 75 IU based on the individual response. The maximum allowed daily dose was 450 IU. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days. |
| |
| Secondary | Number of Participants With Adverse Events | Any adverse event occurring after start of IMP and before the end-of-trial visit, or a pre-treatment adverse event 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. | The safety analysis set was defined as all randomized and exposed participants. Participants were analyzed according to actual treatment received. | Posted | | Number | | percentage of participants | | From screening up to end-of-trial (up to approximately 5.5 months) | | | | ID | Title | Description |
|---|
| OG000 | FE 000049 (Follitropin Delta) | FE 999049 was administered as single daily subcutaneous injections in the abdomen. Participants randomized to FE 999049 had their individual dose determined on the basis of their AMH level at screening and their body weight at randomization. The daily FE 999049 dose was fixed throughout the stimulation period and minimum and maximum allowed daily dose was 6 and 12 μg, respectively. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days. | | OG001 | GONAL-F (Follitropin Alfa) | GONAL-F was administered as single daily subcutaneous injections in the abdomen. The starting dose of GONAL-F was 150 IU and fixed for the first five stimulation days, after which it could be adjusted by 75 IU based on the individual response. The maximum allowed daily dose was 450 IU. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days. |
|
| Secondary | Intensity of Adverse Events | The intensity of adverse event 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). | The safety analysis set was defined as all randomized and exposed participants. Participants were analyzed according to actual treatment received. | Posted | | Number | | percentage of participants | | From screening up to end-of-trial (up to approximately 5.5 months) | | | | ID | Title | Description |
|---|
| OG000 | FE 000049 (Follitropin Delta) | FE 999049 was administered as single daily subcutaneous injections in the abdomen. Participants randomized to FE 999049 had their individual dose determined on the basis of their AMH level at screening and their body weight at randomization. The daily FE 999049 dose was fixed throughout the stimulation period and minimum and maximum allowed daily dose was 6 and 12 μg, respectively. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days. | | OG001 | GONAL-F (Follitropin Alfa) | GONAL-F was administered as single daily subcutaneous injections in the abdomen. The starting dose of GONAL-F was 150 IU and fixed for the first five stimulation days, after which it could be adjusted by 75 IU based on the individual response. The maximum allowed daily dose was 450 IU. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days. |
|
| Secondary | Changes From Baseline in Clinical Chemistry Parameters: 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. | The safety analysis set was defined as all randomized and exposed participants. Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure. | Posted | | Mean | Standard Deviation | IU/L | | From screening up to end-of-trial (up to approximately 5.5 months) | | | | ID | Title | Description |
|---|
| OG000 | FE 000049 (Follitropin Delta) | FE 999049 was administered as single daily subcutaneous injections in the abdomen. Participants randomized to FE 999049 had their individual dose determined on the basis of their AMH level at screening and their body weight at randomization. The daily FE 999049 dose was fixed throughout the stimulation period and minimum and maximum allowed daily dose was 6 and 12 μg, respectively. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days. | | OG001 | GONAL-F (Follitropin Alfa) | GONAL-F was administered as single daily subcutaneous injections in the abdomen. The starting dose of GONAL-F was 150 IU and fixed for the first five stimulation days, after which it could be adjusted by 75 IU based on the individual response. The maximum allowed daily dose was 450 IU. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days. |
|
| Secondary | Change From Baseline in Clinical Chemistry Parameters: 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. | The safety analysis set was defined as all randomized and exposed participants. Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure. | Posted | | Mean | Standard Deviation | mmol/L | | From screening up to end-of-trial (approximately 5.5 months) | | | | ID | Title | Description |
|---|
| OG000 | FE 000049 (Follitropin Delta) | FE 999049 was administered as single daily subcutaneous injections in the abdomen. Participants randomized to FE 999049 had their individual dose determined on the basis of their AMH level at screening and their body weight at randomization. The daily FE 999049 dose was fixed throughout the stimulation period and minimum and maximum allowed daily dose was 6 and 12 μg, respectively. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days. | | OG001 | GONAL-F (Follitropin Alfa) | GONAL-F was administered as single daily subcutaneous injections in the abdomen. The starting dose of GONAL-F was 150 IU and fixed for the first five stimulation days, after which it could be adjusted by 75 IU based on the individual response. The maximum allowed daily dose was 450 IU. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days |
|
| Secondary | Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein | Blood samples were collected for the analysis of clinical chemistry parameters including: Albumin and Protein. | The safety analysis set was defined as all randomized and exposed participants. Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure. | Posted | | Mean | Standard Deviation | g/L | | From screening up to end-of-trial (approximately 5.5 months) | | | | ID | Title | Description |
|---|
| OG000 | FE 000049 (Follitropin Delta) | FE 999049 was administered as single daily subcutaneous injections in the abdomen. Participants randomized to FE 999049 had their individual dose determined on the basis of their AMH level at screening and their body weight at randomization. The daily FE 999049 dose was fixed throughout the stimulation period and minimum and maximum allowed daily dose was 6 and 12 μg, respectively. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days. | | OG001 | GONAL-F (Follitropin Alfa) | GONAL-F was administered as single daily subcutaneous injections in the abdomen. The starting dose of GONAL-F was 150 IU and fixed for the first five stimulation days, after which it could be adjusted by 75 IU based on the individual response. The maximum allowed daily dose was 450 IU. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days |
|
| Secondary | Change From Baseline in Clinical Chemistry Parameter: Lactate Dehydrogenase | Blood samples were collected for the analysis of clinical chemistry parameter including: Lactate dehydrogenase. | The safety analysis set was defined as all randomized and exposed participants. Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure. | Posted | | Mean | Standard Deviation | U/L | | From screening up to end-of-trial (approximately 5.5 months) | | | | ID | Title | Description |
|---|
| OG000 | FE 000049 (Follitropin Delta) | FE 999049 was administered as single daily subcutaneous injections in the abdomen. Participants randomized to FE 999049 had their individual dose determined on the basis of their AMH level at screening and their body weight at randomization. The daily FE 999049 dose was fixed throughout the stimulation period and minimum and maximum allowed daily dose was 6 and 12 μg, respectively. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days. | | OG001 | GONAL-F (Follitropin Alfa) | GONAL-F was administered as single daily subcutaneous injections in the abdomen. The starting dose of GONAL-F was 150 IU and fixed for the first five stimulation days, after which it could be adjusted by 75 IU based on the individual response. The maximum allowed daily dose was 450 IU. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days |
|
| Secondary | Change From Baseline in Clinical Chemistry Parameter: Direct Bilirubin, Bilirubin, Creatinine, Urate | Blood samples were collected for the analysis of clinical chemistry parameter including: Direct bilirubin, Bilirubin, Creatinine, Urate. | The safety analysis set was defined as all randomized and exposed participants. Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure. | Posted | | Mean | Standard Deviation | umol/L | | From screening up to end-of-trial (approximately 5.5 months) | | | | ID | Title | Description |
|---|
| OG000 | FE 000049 (Follitropin Delta) | FE 999049 was administered as single daily subcutaneous injections in the abdomen. Participants randomized to FE 999049 had their individual dose determined on the basis of their AMH level at screening and their body weight at randomization. The daily FE 999049 dose was fixed throughout the stimulation period and minimum and maximum allowed daily dose was 6 and 12 μg, respectively. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days. | | OG001 | GONAL-F (Follitropin Alfa) | GONAL-F was administered as single daily subcutaneous injections in the abdomen. The starting dose of GONAL-F was 150 IU and fixed for the first five stimulation days, after which it could be adjusted by 75 IU based on the individual response. The maximum allowed daily dose was 450 IU. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days |
|
| Secondary | Proportion of Subjects With Markedly Abnormal Changes of Clinical Chemistry: Alanine Aminotransferase, Aspartate Aminotransferase, Bicarbonate, Calcium, Phosphate | The table represents the percentage of participants in each group with normal baseline values and markedly abnormal end-of-stimulation or end-of-trial values for alanine aminotransferase, aspartate aminotransferase, bicarbonate, calcium, phosphate. | The safety analysis set was defined as all randomized and exposed participants. Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure. | Posted | | Number | | percentage of participants | | End-of-stimulation visit and end-of-trial visit | | | | ID | Title | Description |
|---|
| OG000 | FE 000049 (Follitropin Delta) | FE 999049 was administered as single daily subcutaneous injections in the abdomen. Participants randomized to FE 999049 had their individual dose determined on the basis of their AMH level at screening and their body weight at randomization. The daily FE 999049 dose was fixed throughout the stimulation period and minimum and maximum allowed daily dose was 6 and 12 μg, respectively. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days. | | OG001 | GONAL-F (Follitropin Alfa) | GONAL-F was administered as single daily subcutaneous injections in the abdomen. The starting dose of GONAL-F was 150 IU and fixed for the first five stimulation days, after which it could be adjusted by 75 IU based on the individual response. The maximum allowed daily dose was 450 IU. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days. |
|
| Secondary | Change From Baseline in Haematology Parameter: Erythrocytes | Blood samples were collected for the analysis of haematology parameter including: Erythrocytes. | The safety analysis set was defined as all randomized and exposed participants. Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure. | Posted | | Mean | Standard Deviation | 10^12 cells/L | | From screening up to end-of-trial (approximately 5.5 months) | | | | ID | Title | Description |
|---|
| OG000 | FE 000049 (Follitropin Delta) | FE 999049 was administered as single daily subcutaneous injections in the abdomen. Participants randomized to FE 999049 had their individual dose determined on the basis of their AMH level at screening and their body weight at randomization. The daily FE 999049 dose was fixed throughout the stimulation period and minimum and maximum allowed daily dose was 6 and 12 μg, respectively. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days. | | OG001 | GONAL-F (Follitropin Alfa) | GONAL-F was administered as single daily subcutaneous injections in the abdomen. The starting dose of GONAL-F was 150 IU and fixed for the first five stimulation days, after which it could be adjusted by 75 IU based on the individual response. The maximum allowed daily dose was 450 IU. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days. |
|
| Secondary | Change From Baseline in Haematology Parameters: Leukocytes and Platelets | Blood samples were collected for the analysis of haematology parameters including: Leukocytes and Platelets. | The safety analysis set was defined as all randomized and exposed participants. Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure. | Posted | | Mean | Standard Deviation | 10^9 cells/L | | From screening up to end-of-trial (approximately 5.5 months) | | | | ID | Title | Description |
|---|
| OG000 | FE 000049 (Follitropin Delta) | FE 999049 was administered as single daily subcutaneous injections in the abdomen. Participants randomized to FE 999049 had their individual dose determined on the basis of their AMH level at screening and their body weight at randomization. The daily FE 999049 dose was fixed throughout the stimulation period and minimum and maximum allowed daily dose was 6 and 12 μg, respectively. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days. | | OG001 | GONAL-F (Follitropin Alfa) | GONAL-F was administered as single daily subcutaneous injections in the abdomen. The starting dose of GONAL-F was 150 IU and fixed for the first five stimulation days, after which it could be adjusted by 75 IU based on the individual response. The maximum allowed daily dose was 450 IU. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days |
|
| Secondary | Change From Baseline in Haematology Parameter: Haemoglobin | Blood samples were collected for the analysis of haematology parameter including: Haemoglobin. | The safety analysis set was defined as all randomized and exposed participants. Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure. | Posted | | Mean | Standard Deviation | g/L | | From screening up to end-of-trial (approximately 5.5 months) | | | | ID | Title | Description |
|---|
| OG000 | FE 000049 (Follitropin Delta) | FE 999049 was administered as single daily subcutaneous injections in the abdomen. Participants randomized to FE 999049 had their individual dose determined on the basis of their AMH level at screening and their body weight at randomization. The daily FE 999049 dose was fixed throughout the stimulation period and minimum and maximum allowed daily dose was 6 and 12 μg, respectively. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days. | | OG001 | GONAL-F (Follitropin Alfa) | GONAL-F was administered as single daily subcutaneous injections in the abdomen. The starting dose of GONAL-F was 150 IU and fixed for the first five stimulation days, after which it could be adjusted by 75 IU based on the individual response. The maximum allowed daily dose was 450 IU. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days |
|
| Secondary | Change From Baseline in Haematology Parameter: Haematocrit | Blood samples were collected for the analysis of haematology parameter including: Haematocrit. | The safety analysis set was defined as all randomized and exposed participants. Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure. | Posted | | Mean | Standard Deviation | Ratio | | From screening up to end-of-trial (approximately 5.5 months) | | | | ID | Title | Description |
|---|
| OG000 | FE 000049 (Follitropin Delta) | FE 999049 was administered as single daily subcutaneous injections in the abdomen. Participants randomized to FE 999049 had their individual dose determined on the basis of their AMH level at screening and their body weight at randomization. The daily FE 999049 dose was fixed throughout the stimulation period and minimum and maximum allowed daily dose was 6 and 12 μg, respectively. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days. | | OG001 | GONAL-F (Follitropin Alfa) | GONAL-F was administered as single daily subcutaneous injections in the abdomen. The starting dose of GONAL-F was 150 IU and fixed for the first five stimulation days, after which it could be adjusted by 75 IU based on the individual response. The maximum allowed daily dose was 450 IU. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days |
|
| Secondary | Change From Baseline in Haematology Parameter: Erythrocyte Mean Corpuscular Volume | Blood samples were collected for the analysis of haematology parameter including: Erythrocyte mean corpuscular volume. | The safety analysis set was defined as all randomized and exposed participants. Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure. | Posted | | Mean | Standard Deviation | Femtoliters | | From screening up to end-of-trial (approximately 5.5 months) | | | | ID | Title | Description |
|---|
| OG000 | FE 000049 (Follitropin Delta) | FE 999049 was administered as single daily subcutaneous injections in the abdomen. Participants randomized to FE 999049 had their individual dose determined on the basis of their AMH level at screening and their body weight at randomization. The daily FE 999049 dose was fixed throughout the stimulation period and minimum and maximum allowed daily dose was 6 and 12 μg, respectively. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days. | | OG001 | GONAL-F (Follitropin Alfa) | GONAL-F was administered as single daily subcutaneous injections in the abdomen. The starting dose of GONAL-F was 150 IU and fixed for the first five stimulation days, after which it could be adjusted by 75 IU based on the individual response. The maximum allowed daily dose was 450 IU. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days |
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| Secondary | Change From Baseline in Haematology Parameter: Erythrocyte Mean Corpuscular Haemoglobin | Blood samples were collected for the analysis of haematology parameter including: Erythrocyte mean corpuscular haemoglobin. | The safety analysis set was defined as all randomized and exposed participants. Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure. | Posted | | Mean | Standard Deviation | picogram | | From screening up to end-of-trial (approximately 5.5 months) | | | | ID | Title | Description |
|---|
| OG000 | FE 000049 (Follitropin Delta) | FE 999049 was administered as single daily subcutaneous injections in the abdomen. Participants randomized to FE 999049 had their individual dose determined on the basis of their AMH level at screening and their body weight at randomization. The daily FE 999049 dose was fixed throughout the stimulation period and minimum and maximum allowed daily dose was 6 and 12 μg, respectively. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days. | | OG001 | GONAL-F (Follitropin Alfa) | GONAL-F was administered as single daily subcutaneous injections in the abdomen. The starting dose of GONAL-F was 150 IU and fixed for the first five stimulation days, after which it could be adjusted by 75 IU based on the individual response. The maximum allowed daily dose was 450 IU. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days |
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| Secondary | Change From Baseline in Haematology Parameter: Erythrocyte Mean Corpuscular Haemoglobin Concentration | Blood samples were collected for the analysis of haematology parameter including: Erythrocyte mean corpuscular haemoglobin concentration. | The safety analysis set was defined as all randomized and exposed participants. Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure. | Posted | | Mean | Standard Deviation | mmol/L | | From screening up to end-of-trial (approximately 5.5 months) | | | | ID | Title | Description |
|---|
| OG000 | FE 000049 (Follitropin Delta) | FE 999049 was administered as single daily subcutaneous injections in the abdomen. Participants randomized to FE 999049 had their individual dose determined on the basis of their AMH level at screening and their body weight at randomization. The daily FE 999049 dose was fixed throughout the stimulation period and minimum and maximum allowed daily dose was 6 and 12 μg, respectively. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days. | | OG001 | GONAL-F (Follitropin Alfa) | GONAL-F was administered as single daily subcutaneous injections in the abdomen. The starting dose of GONAL-F was 150 IU and fixed for the first five stimulation days, after which it could be adjusted by 75 IU based on the individual response. The maximum allowed daily dose was 450 IU. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days |
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| Secondary | Change From Baseline in Haematology Parameters: 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. | The safety analysis set was defined as all randomized and exposed participants. Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure. | Posted | | Mean | Standard Deviation | percentage | | From screening up to end-of-trial (approximately 5.5 months) | | | | ID | Title | Description |
|---|
| OG000 | FE 000049 (Follitropin Delta) | FE 999049 was administered as single daily subcutaneous injections in the abdomen. Participants randomized to FE 999049 had their individual dose determined on the basis of their AMH level at screening and their body weight at randomization. The daily FE 999049 dose was fixed throughout the stimulation period and minimum and maximum allowed daily dose was 6 and 12 μg, respectively. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days. | | OG001 | GONAL-F (Follitropin Alfa) | GONAL-F was administered as single daily subcutaneous injections in the abdomen. The starting dose of GONAL-F was 150 IU and fixed for the first five stimulation days, after which it could be adjusted by 75 IU based on the individual response. The maximum allowed daily dose was 450 IU. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days |
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| Secondary | Proportion of Subjects With Markedly Abnormal Changes of Haematology Parameters: Leukocytes, Lymphocytes/Leukocytes | The table represents the percentage of participants in each group with normal baseline values and markedly abnormal end-of-stimulation and end-of-trial values for leukocytes and lymphocytes/leukocytes. | The safety analysis set was defined as all randomized and exposed participants. Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure. | Posted | | Number | | percentage of participants | | End-of-stimulation visit and end-of-trial visit | | | | ID | Title | Description |
|---|
| OG000 | FE 000049 (Follitropin Delta) | FE 999049 was administered as single daily subcutaneous injections in the abdomen. Participants randomized to FE 999049 had their individual dose determined on the basis of their AMH level at screening and their body weight at randomization. The daily FE 999049 dose was fixed throughout the stimulation period and minimum and maximum allowed daily dose was 6 and 12 μg, respectively. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days. | | OG001 | GONAL-F (Follitropin Alfa) | GONAL-F was administered as single daily subcutaneous injections in the abdomen. The starting dose of GONAL-F was 150 IU and fixed for the first five stimulation days, after which it could be adjusted by 75 IU based on the individual response. The maximum allowed daily dose was 450 IU. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days |
|
| Secondary | Number of Immune-related Adverse Events | Standardised Medical Dictionary for Regulatory Activities (MedDRA) Queries (SMQs). | The safety analysis set was defined as all randomized and exposed participants. Participants were analyzed according to actual treatment received. | Posted | | Number | | events | | From screening up to end-of-trial (approximately 5.5 months) | | | | ID | Title | Description |
|---|
| OG000 | FE 000049 (Follitropin Delta) | FE 999049 was administered as single daily subcutaneous injections in the abdomen. Participants randomized to FE 999049 had their individual dose determined on the basis of their AMH level at screening and their body weight at randomization. The daily FE 999049 dose was fixed throughout the stimulation period and minimum and maximum allowed daily dose was 6 and 12 μg, respectively. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days. | | OG001 | GONAL-F (Follitropin Alfa) | GONAL-F was administered as single daily subcutaneous injections in the abdomen. The starting dose of GONAL-F was 150 IU and fixed for the first five stimulation days, after which it could be adjusted by 75 IU based on the individual response. The maximum allowed daily dose was 450 IU. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days. |
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| Secondary | Frequency of Injection Site Reactions | 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 was defined as all randomized and exposed participants. Participants were analyzed according to actual treatment received. | Posted | | Number | | percentage of participants | | End-of-stimulation (up to 20 stimulation days) | | | | ID | Title | Description |
|---|
| OG000 | FE 000049 (Follitropin Delta) | FE 999049 was administered as single daily subcutaneous injections in the abdomen. Participants randomized to FE 999049 had their individual dose determined on the basis of their AMH level at screening and their body weight at randomization. The daily FE 999049 dose was fixed throughout the stimulation period and minimum and maximum allowed daily dose was 6 and 12 μg, respectively. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days. | | OG001 | GONAL-F (Follitropin Alfa) | GONAL-F was administered as single daily subcutaneous injections in the abdomen. The starting dose of GONAL-F was 150 IU and fixed for the first five stimulation days, after which it could be adjusted by 75 IU based on the individual response. The maximum allowed daily dose was 450 IU. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days. |
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| Secondary | Intensity of Injection Site Reactions | Assessed by the participant during the stimulation period as mild, moderate or severe. Participants are tabulated according to the highest severity of their reported injection site reactions. | The safety analysis set was defined as all randomized and exposed participants. Participants were analyzed according to actual treatment received. | Posted | | Number | | percentage of participants | | End-of-stimulation (up to 20 stimulation days) | | | | ID | Title | Description |
|---|
| OG000 | FE 000049 (Follitropin Delta) | FE 999049 was administered as single daily subcutaneous injections in the abdomen. Participants randomized to FE 999049 had their individual dose determined on the basis of their AMH level at screening and their body weight at randomization. The daily FE 999049 dose was fixed throughout the stimulation period and minimum and maximum allowed daily dose was 6 and 12 μg, respectively. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days. | | OG001 | GONAL-F (Follitropin Alfa) | GONAL-F was administered as single daily subcutaneous injections in the abdomen. The starting dose of GONAL-F was 150 IU and fixed for the first five stimulation days, after which it could be adjusted by 75 IU based on the individual response. The maximum allowed daily dose was 450 IU. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days. |
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| Secondary | Proportion of Subjects With Treatment-induced Anti-FSH Antibodies, Overall as Well as With Neutralizing Capacity | Measured by presence of anti-FSH antibodies. | The safety analysis set was defined as 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 000049 (Follitropin Delta) | FE 999049 was administered as single daily subcutaneous injections in the abdomen. Participants randomized to FE 999049 had their individual dose determined on the basis of their AMH level at screening and their body weight at randomization. The daily FE 999049 dose was fixed throughout the stimulation period and minimum and maximum allowed daily dose was 6 and 12 μg, respectively. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days. | | OG001 | GONAL-F (Follitropin Alfa) | GONAL-F was administered as single daily subcutaneous injections in the abdomen. The starting dose of GONAL-F was 150 IU and fixed for the first five stimulation days, after which it could be adjusted by 75 IU based on the individual response. The maximum allowed daily dose was 450 IU. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days. |
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| Secondary | Intensity of Immune-related Adverse Events | The intensity of immune-related adverse event 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). | The safety analysis set was defined as all randomized and exposed participants. Participants were analyzed according to actual treatment received. | Posted | | Number | | events | | From screening up to end-of-trial (approximately 5.5 months) | | | | ID | Title | Description |
|---|
| OG000 | FE 000049 (Follitropin Delta) | FE 999049 was administered as single daily subcutaneous injections in the abdomen. Participants randomized to FE 999049 had their individual dose determined on the basis of their AMH level at screening and their body weight at randomization. The daily FE 999049 dose was fixed throughout the stimulation period and minimum and maximum allowed daily dose was 6 and 12 μg, respectively. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days. | | OG001 | GONAL-F (Follitropin Alfa) | GONAL-F was administered as single daily subcutaneous injections in the abdomen. The starting dose of GONAL-F was 150 IU and fixed for the first five stimulation days, after which it could be adjusted by 75 IU based on the individual response. The maximum allowed daily dose was 450 IU. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days. |
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| 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. | The FAS was defined as all randomized and exposed participants. Participants were analyzed according to randomized treatment. | Posted | | Number | | percentage of participants | | Up to 20 stimulation days | | | | ID | Title | Description |
|---|
| OG000 | FE 000049 (Follitropin Delta) | FE 999049 was administered as single daily subcutaneous injections in the abdomen. Participants randomized to FE 999049 had their individual dose determined on the basis of their AMH level at screening and their body weight at randomization. The daily FE 999049 dose was fixed throughout the stimulation period and minimum and maximum allowed daily dose was 6 and 12 μg, respectively. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days. | | OG001 | GONAL-F (Follitropin Alfa) | GONAL-F was administered as single daily subcutaneous injections in the abdomen. The starting dose of GONAL-F was 150 IU and fixed for the first five stimulation days, after which it could be adjusted by 75 IU based on the individual response. The maximum allowed daily dose was 450 IU. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days. |
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| Secondary | Proportion of Subjects With Late OHSS | Late OHSS was defined as OHSS with onset >9 days after triggering of final follicular maturation. The proportion of participants with late OHSS, and late OHSS of moderate or severe grade are presented. All OHSS cases were graded as mild, moderate, or severe. | The safety analysis set was defined as all randomized and exposed participants. Participants were analyzed according to actual treatment received. | Posted | | Number | | percentage of participants | | After 9 days post triggering of final follicular maturation | | | | ID | Title | Description |
|---|
| OG000 | FE 000049 (Follitropin Delta) | FE 999049 was administered as single daily subcutaneous injections in the abdomen. Participants randomized to FE 999049 had their individual dose determined on the basis of their AMH level at screening and their body weight at randomization. The daily FE 999049 dose was fixed throughout the stimulation period and minimum and maximum allowed daily dose was 6 and 12 μg, respectively. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days. | | OG001 | GONAL-F (Follitropin Alfa) | GONAL-F was administered as single daily subcutaneous injections in the abdomen. The starting dose of GONAL-F was 150 IU and fixed for the first five stimulation days, after which it could be adjusted by 75 IU based on the individual response. The maximum allowed daily dose was 450 IU. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days. |
|
| Secondary | Proportion of Participants With Multi-fetal Gestation | Defined as pregnancy with more than one fetus. Among participants with ongoing pregnancy, percentage of participants with twin pregnancies are presented. | The FAS was defined as all randomized and exposed participants. Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure. | Posted | | Number | | percentage of participants | | End-of-trial | | | | ID | Title | Description |
|---|
| OG000 | FE 000049 (Follitropin Delta) | FE 999049 was administered as single daily subcutaneous injections in the abdomen. Participants randomized to FE 999049 had their individual dose determined on the basis of their AMH level at screening and their body weight at randomization. The daily FE 999049 dose was fixed throughout the stimulation period and minimum and maximum allowed daily dose was 6 and 12 μg, respectively. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days. | | OG001 | GONAL-F (Follitropin Alfa) | GONAL-F was administered as single daily subcutaneous injections in the abdomen. The starting dose of GONAL-F was 150 IU and fixed for the first five stimulation days, after which it could be adjusted by 75 IU based on the individual response. The maximum allowed daily dose was 450 IU. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days |
|
| Secondary | Proportion of Participants With Early Pregnancy Losses | Grouped according to occurrence of biochemical pregnancy, spontaneous abortion, vanishing twin or ectopic pregnancy (with and without medical/surgical intervention). Frequency of early pregnancy losses are presented. | The safety analysis set was defined as all randomized and exposed participants. Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure. | Posted | | Number | | percentage of participants | | End-of-trial | | | | ID | Title | Description |
|---|
| OG000 | FE 000049 (Follitropin Delta) | FE 999049 was administered as single daily subcutaneous injections in the abdomen. Participants randomized to FE 999049 had their individual dose determined on the basis of their AMH level at screening and their body weight at randomization. The daily FE 999049 dose was fixed throughout the stimulation period and minimum and maximum allowed daily dose was 6 and 12 μg, respectively. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days. | | OG001 | GONAL-F (Follitropin Alfa) | GONAL-F was administered as single daily subcutaneous injections in the abdomen. The starting dose of GONAL-F was 150 IU and fixed for the first five stimulation days, after which it could be adjusted by 75 IU based on the individual response. The maximum allowed daily dose was 450 IU. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days. |
|
| 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 was defined as all randomized and exposed participants. Participants were analyzed according to actual treatment received. | Posted | | Number | | percentage of participants | | End-of-stimulation (up to 20 stimulation days) | | | | ID | Title | Description |
|---|
| OG000 | FE 000049 (Follitropin Delta) | FE 999049 was administered as single daily subcutaneous injections in the abdomen. Participants randomized to FE 999049 had their individual dose determined on the basis of their AMH level at screening and their body weight at randomization. The daily FE 999049 dose was fixed throughout the stimulation period and minimum and maximum allowed daily dose was 6 and 12 μg, respectively. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days. | | OG001 | GONAL-F (Follitropin Alfa) | GONAL-F was administered as single daily subcutaneous injections in the abdomen. The starting dose of GONAL-F was 150 IU and fixed for the first five stimulation days, after which it could be adjusted by 75 IU based on the individual response. The maximum allowed daily dose was 450 IU. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days. |
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