| Primary | Number of Oocytes Retrieved (Per Protocol Population) | As soon as ovulation criteria were reached, HCG was given to trigger ovulation and 34-36 hours later, oocytes were retrieved. If criteria for ovulation triggering could not be reached by FSH stimulation on day 16, treatment was to be stopped. The equivalence in the number of retrieved oocytes was tested using a pre-determined clinical equivalence margin of +/- 2.9 oocytes | | Posted | | Mean | Standard Deviation | Number of retrieved oocytes | | 34-36 hours after hCG administration and after maximum 16 days of r-hFSH treatment | | | | ID | Title | Description |
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| OG000 | AFOLIA-150 (Follitropin Alfa) | Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days | | OG001 | Gonal-f® (Follitropin Alfa) | Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days |
| | | Title | Denominators | Categories |
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| | | Title | Measurements |
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| - OG00010.8± 5.11
- OG00110.6± 6.06
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| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
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| This study was powered to test equivalence using a two one-sided test (TOST) of the number of oocytes retrieved. | Shuirmann's TOST | | 0.0003 | This study was powered to test equivalence using a two one-sided test (TOST) with a power of 90%, an alpha error of 2.5% and a pre-determined clinical equivalence margin of +/-2.9 oocytes for the relevant population. | | | | | 2-Sided | | | | | | | Yes | Non-Inferiority or Equivalence | This study was powered to test equivalence using a two one-sided test (TOST) of the number of oocytes retrieved with a power of 90%, an alpha error of 2.5% and a pre-determined clinical equivalence margin of +/-2.9 oocytes for the relevant population. |
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| Secondary | Number and Size of Follicles ≥ 12 mm at Day 8 of Stimulation | The number and size of follicles 12 mm or over in diameter at day 8 of stimulation were evaluated as secondary end-point. | All participants were analyzed. | Posted | | Mean | Standard Deviation | Number of follicles | | Day 8 of stimulation | | | | ID | Title | Description |
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| OG000 | AFOLIA-150 (Follitropin Alfa) | Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days | | OG001 | Gonal-f® (Follitropin Alfa) | Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days |
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| Secondary | E2 Concentration at Day 8 and at Day of hCG Administration | The serum concentration of oestradiol was assessed at day 8 and the day of hCG administration. | All participants were analyzed. | Posted | | Mean | Standard Deviation | pmol/ L | | Day 8 of stimulation and at the day of hCG administration (after max. 16 days of r-FSH treatment) | | | | ID | Title | Description |
|---|
| OG000 | AFOLIA-150 (Follitropin Alfa) | Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days | | OG001 | Gonal-f® (Follitropin Alfa) | Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days |
| |
| Secondary | Total Dose of r-hFSH Administered | Total dose of r-hFSH required was assessed. | All participants were analyzed. | Posted | | Mean | Standard Deviation | IU | | Day of hCG administration (after maximum 16 days of r-hFSH treatment) | | | | ID | Title | Description |
|---|
| OG000 | AFOLIA-150 (Follitropin Alfa) | Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days | | OG001 | Gonal-f® (Follitropin Alfa) | Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days |
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| Secondary | Quality of Oocytes Retrieved | Number of patients with ovum pick-up | Intention to treat population | Posted | | Number | | Participants | | 34-36 hours after hCG administration | | | | ID | Title | Description |
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| OG000 | AFOLIA-150 (Follitropin Alfa) | Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days | | OG001 | Gonal-f® (Follitropin Alfa) | Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days |
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| Secondary | Fertilisation Rate of Oocytes | Fertilisation rate was assessed | Intention to treat population | Posted | | Mean | Standard Deviation | percentage of oocytes | | 1 day after ovum pick-up | | | | ID | Title | Description |
|---|
| OG000 | AFOLIA-150 (Follitropin Alfa) | Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days | | OG001 | Gonal-f® (Follitropin Alfa) | Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days |
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| Secondary | Embryo Quality: Mean Number of Blastomeres | Main embryo quality parameter "mean number of blastomeres" | Intention to treat population | Posted | | Mean | Standard Deviation | Number of blastomeres at day 3 | | Day 2 of OPU/fertilisation | | | | ID | Title | Description |
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| OG000 | AFOLIA-150 (Follitropin Alfa) | Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days | | OG001 | Gonal-f® (Follitropin Alfa) | Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days |
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| Secondary | Number of Participants With Cryopreserved 2PNs, Embryos/Blastocysts | | Intention to treat population | Posted | | Number | | Patients with cryopreservation | | Day 1, 2, 3 and 5 of OPU/fertilisation | | | | ID | Title | Description |
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| OG000 | AFOLIA-150 (Follitropin Alfa) | Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days | | OG001 | Gonal-f® (Follitropin Alfa) | Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days |
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| Secondary | Number of Days of r-hFSH Stimulation | Mean duration of stimulation was assessed. | All participants were analyzed. | Posted | | Mean | Standard Deviation | days | | At the day of hCG administration, up to 16 days | | | | ID | Title | Description |
|---|
| OG000 | AFOLIA-150 (Follitropin Alfa) | Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days | | OG001 | Gonal-f® (Follitropin Alfa) | Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days |
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| Secondary | Number of Patients With Cycle Cancellation | Number of patients with cycle cancellation was assessed. | Intention to treat population | Posted | | Number | | Number of patients | | Until child birth/miscarriage, up to the end of the study | | | | ID | Title | Description |
|---|
| OG000 | AFOLIA-150 (Follitropin Alfa) | Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days | | OG001 | Gonal-f® (Follitropin Alfa) | Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days |
| |
| Secondary | Number of Patients With Good Response | Good response was defined as "patients with an oocyte retrieval of four or more oocytes" | Intention to treat population. | Posted | | Number | | Participants | | Until child birth/miscarriage, up to the end of the study | | | | ID | Title | Description |
|---|
| OG000 | AFOLIA-150 (Follitropin Alfa) | Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days | | OG001 | Gonal-f® (Follitropin Alfa) | Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days |
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| Secondary | Implantation Rate | Defined as fetal sac per embryo transferred. | Intention to treat population. | Posted | | Number | | Percentage of implantations | | Five to six weeks after oocyte retrieval | | | | ID | Title | Description |
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| OG000 | AFOLIA-150 (Follitropin Alfa) | Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days | | OG001 | Gonal-f® (Follitropin Alfa) | Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days |
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| Secondary | Clinical Pregnancy Rate | Presence of at least one intrauterine gestational sac. | Intention to treat population | Posted | | Number | | Clinical pregnancies | | Five to six weeks after oocyte retrieval | | | | ID | Title | Description |
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| OG000 | AFOLIA-150 (Follitropin Alfa) | Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days | | OG001 | Gonal-f® (Follitropin Alfa) | Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days |
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| Secondary | Ongoing Pregnancy | Ongoing pregnancy per embryo transfer. Presence of at least one viable fetus 10 weeks after embryo transfer. | Intention to treat population | Posted | | Number | | Ongoing pregnancies | | Ten weeks after embryo transfer | | | | ID | Title | Description |
|---|
| OG000 | AFOLIA-150 (Follitropin Alfa) | Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days | | OG001 | Gonal-f® (Follitropin Alfa) | Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days |
| |
| Secondary | Live Birth Rate | Patients with liveborn children | Intention to treat population | Posted | | Number | | Patients with liveborn children | | After childbirth with questionnaire | | | | ID | Title | Description |
|---|
| OG000 | AFOLIA-150 (Follitropin Alfa) | Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days | | OG001 | Gonal-f® (Follitropin Alfa) | Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days |
| |
| Primary | Number of Oocytes Retrieved (Intention-to-treat Population) | As soon as ovulation criteria were reached, HCG was given to trigger ovulation and 34-36 hours later, oocytes were retrieved. If criteria for ovulation triggering could not be reached by FSH stimulation on day 16, treatment was to be stopped. The equivalence in the number of retrieved oocytes was tested using a pre-determined clinical equivalence margin of +/- 2.9 oocytes | Intention-to-treat population | Posted | | Mean | Standard Deviation | Number of retrieved oocytes | | 34-36 hours after hCG administration and after maximum 16 days of r-hFSH treatment | | | | ID | Title | Description |
|---|
| OG000 | AFOLIA-150 (Follitropin Alfa) | Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days | | OG001 | Gonal-f® (Follitropin Alfa) | Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days |
| |
| Secondary | Embryo Quality: Absence of Multinucleation | Main embryo quality parameter "absence of multinucleation" observed. | Intention to treat population | Posted | | Number | | Percentage of absent multinucleation | | Day 3 | | | | ID | Title | Description |
|---|
| OG000 | AFOLIA-150 (Follitropin Alfa) | Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days | | OG001 | Gonal-f® (Follitropin Alfa) | Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days |
| |
| Secondary | Quality of Oocytes Retrieved | Number of patients with transferred blastocysts | Intention to treat population | Posted | | Number | | Participants | | At day 4 and 5 | | | | ID | Title | Description |
|---|
| OG000 | AFOLIA-150 (Follitropin Alfa) | Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days | | OG001 | Gonal-f® (Follitropin Alfa) | Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days |
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| Secondary | Quality of Oocytes Retrieved | Number of embryos per blastocysts transferred | Intention to treat population | Posted | | Mean | Standard Deviation | embryos per blastocysts transferred | | Day of embryo transfer, either 2, 3 or 5 days after oocyte retrieval | | | | ID | Title | Description |
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| OG000 | AFOLIA-150 (Follitropin Alfa) | Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days | | OG001 | Gonal-f® (Follitropin Alfa) | Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days |
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| Secondary | Clinical Pregnancy Rate (Second Treatment Cycle) | Presence of at least one intrauterine gestational sac. | Population with a second treatment cycle | Posted | | Number | | Clinical pregnancies | | Five to six weeks after oocyte retrieval | | | | ID | Title | Description |
|---|
| OG000 | AFOLIA-150 (Follitropin Alfa) | Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days | | OG001 | Gonal-f® (Follitropin Alfa) | Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days |
| |
| Secondary | Ongoing Pregnancy (Second Treatment Cycle) | Ongoing pregnancy per embryo transfer. Presence of at least one viable fetus 10 weeks after embryo transfer. | Population with a second treatment cycle | Posted | | Number | | Ongoing pregnancies | | 10 weeks after embryo transfer | | | | ID | Title | Description |
|---|
| OG000 | AFOLIA-150 (Follitropin Alfa) | Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days | | OG001 | Gonal-f® (Follitropin Alfa) | Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days |
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| Secondary | Quality of Oocytes Retrieved | The maturity of the cumulus oophorus was assessed. | Intention to treat population | Posted | | Number | | Percentage of cumulus oophori | | After oocyte retrieval, 34 to 36 hours after hCG administration | | | | ID | Title | Description |
|---|
| OG000 | AFOLIA-150 (Follitropin Alfa) | Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days | | OG001 | Gonal-f® (Follitropin Alfa) | Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days |
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| Secondary | Quality of Oocytes Retrieved | The nuclear maturity was assessed (Germinal vesicle, Metaphase I, Metaphase II). | Intention to treat population | Posted | | Number | | Percentage of cells | | After oocyte retrieval, 34 to 36 hours after hCG administration | | | | ID | Title | Description |
|---|
| OG000 | AFOLIA-150 (Follitropin Alfa) | Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days | | OG001 | Gonal-f® (Follitropin Alfa) | Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days |
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