| Primary | Ongoing Pregnancy Rate | Defined as the percentage of participants with the presence of at least 1 intrauterine pregnancy with a detectable fetal heartbeat at 10-11 weeks of gestation. | The modified intent-to-treat (mITT) analysis set comprised all randomized participants who received at least 1 dose of investigational medicinal product. | Posted | | Number | | percentage of participants | | 8-9 weeks after blastocyst transfer in the fresh cycle | | | | ID | Title | Description |
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| OG000 | Menotropin | Menotropins for injection, provided as a vial with powder (75 IU activity and 75 IU LH activity) and a vial with diluent. | | OG001 | Recombinant FSH | Follitropin alpha for injection, a human FSH preparation of recombinant DNA origin, provided as pen and cartridges filled with either 300 or 450 IU of FSH activity. |
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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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| Null hypothesis was defined as the difference between ongoing pregnancy rate of participants randomized and treated with menotropin and recombinant FSH, as ≤-12%. | | | | | Absolute difference | 4.7 | | | 2-Sided | 95 | -2.7 | 12.1 | | | | | Non-Inferiority | The study had at least 80% power, to demonstrate the non-inferiority of menotropin to recombinant FSH at 1-sided significance level of 0.025 with a -12% non-inferiority margin. | |
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| Secondary | Positive β-human Chorionic Gonadotropin (hCG) Rate | Defined as the percentage of participants with 2 positive β-hCG tests within 2 days in serum. | The mITT analysis set comprised all randomized participants who received at least 1 dose of investigational medicinal product. | Posted | | Number | | percentage of participants | | First test approximately 10-14 days after blastocyst transfer in the fresh cycle, with a second test approximately 2 days later if first test was positive | | | | ID | Title | Description |
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| OG000 | Menotropin | Menotropins for injection, provided as a vial with powder (75 IU FSH activity and 75 IU LH activity) and a vial with diluent. | | OG001 | Recombinant FSH | Follitropin alpha for injection, a human FSH preparation of recombinant DNA origin, provided as pen and cartridges filled with either 300 or 450 IU of FSH activity. |
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| Secondary | Clinical Pregnancy Rate | Defined as percentage of participants with transvaginal ultrasound (TVUS) showing at least 1 intrauterine gestational sac with fetal heart beat at 6-7 weeks of gestation. | The mITT analysis set comprised all randomized participants who received at least 1 dose of investigational medicinal product. | Posted | | Number | | percentage of participants | | 4-5 weeks after blastocyst transfer in the fresh cycle | | | | ID | Title | Description |
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| OG000 | Menotropin | Menotropins for injection, provided as a vial with powder (75 IU FSH activity and 75 IU LH activity) and a vial with diluent. | | OG001 | Recombinant FSH | Follitropin alpha for injection, a human FSH preparation of recombinant DNA origin, provided as pen and cartridges filled with either 300 or 450 IU of FSH activity. |
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| Secondary | Early Pregnancy Loss | Defined as participants with 2 positive β-hCG tests but no ongoing pregnancy at 10-11 weeks of gestation in the fresh cycle. Percentage of participants with early pregnancy loss is presented. | The mITT analysis set comprised all randomized participants who received at least 1 dose of investigational medicinal product. | Posted | | Number | | percentage of participants | | At 10-11 weeks of gestation in the fresh cycle | | | | ID | Title | Description |
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| OG000 | Menotropin | Menotropins for injection, provided as a vial with powder (75 IU FSH activity and 75 IU LH activity) and a vial with diluent. | | OG001 | Recombinant FSH | Follitropin alpha for injection, a human FSH preparation of recombinant DNA origin, provided as pen and cartridges filled with either 300 or 450 IU of FSH activity. |
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| Secondary | Follicular Development as Assessed by TVUS | Defined as average follicle size and average size of 3 largest follicles. | The mITT analysis set comprised all randomized participants who received at least 1 dose of investigational medicinal product. | Posted | | Mean | Standard Deviation | mm | | On stimulation Day 6 and last day of stimulation (a maximum of 20 stimulation days) | | | | ID | Title | Description |
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| OG000 | Menotropin, Stimulation Day 6 | Menotropins for injection at stimulation Day 6. Menotropins for injection, provided as a vial with powder (75 IU FSH activity and 75 IU LH activity) and a vial with diluent. | | OG001 | Recombinant FSH, Stimulation Day 6 | Recombinant FSH at stimulation Day 6. Follitropin alpha for injection, a human FSH preparation of recombinant DNA origin, provided as pen and cartridges filled with either 300 or 450 IU of FSH activity. | | OG002 | Menotropin, Last Stimulation Day | Menotropin at last stimulation day. Menotropins for injection, provided as a vial with powder (75 IU FSH activity and 75 IU LH activity) and a vial with diluent. | | OG003 |
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| Secondary | Follicular Development as Assessed by TVUS | Defined as percentage of participants with follicles having a diameter of ≤9 mm, 10-11 mm, 12-14 mm, 15-16 mm, and ≥17 mm. | The mITT analysis set comprised all randomized participants who received at least 1 dose of investigational medicinal product. | Posted | | Number | | percentage of participants | | On stimulation Day 6 and last day of stimulation (a maximum of 20 stimulation days) | | | | ID | Title | Description |
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| OG000 | Menotropin, Stimulation Day 6 | Menotropins for injection at stimulation Day 6. Menotropins for injection, provided as a vial with powder (75 IU FSH activity and 75 IU LH activity) and a vial with diluent. | | OG001 | Recombinant FSH, Stimulation Day 6 | Recombinant FSH at stimulation Day 6. Follitropin alpha for injection, a human FSH preparation of recombinant DNA origin, provided as pen and cartridges filled with either 300 or 450 IU of FSH activity. | | OG002 | Menotropin, Last Stimulation Day | Menotropin at last stimulation day. Menotropins for injection, provided as a vial with powder (75 IU FSH activity and 75 IU LH activity) and a vial with diluent. | |
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| Secondary | Number of Oocytes Retrieved | | The mITT analysis set comprised all randomized participants who received at least 1 dose of investigational medicinal product. The number of participants analyzed represent the participants with oocytes retrieved. | Posted | | Mean | Standard Deviation | oocytes | | At oocyte retrieval visit (approximately 36 hours after hCG administration) | | | | ID | Title | Description |
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| OG000 | Menotropin | Menotropins for injection, provided as a vial with powder (75 IU FSH activity and 75 IU LH activity) and a vial with diluent. | | OG001 | Recombinant FSH | Follitropin alpha for injection, human FSH preparation of recombinant DNA origin, provided as pen and cartridges filled with either 300 or 450 IU of FSH activity. |
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| Secondary | Number of Metaphase II Oocytes | | The mITT analysis set comprised all randomized participants who received at least 1 dose of investigational medicinal product. The number of participants analyzed represent the participants with oocytes retrieved. | Posted | | Mean | Standard Deviation | metaphase II oocytes | | At oocyte retrieval visit (approximately 36 hours after hCG administration) | | | | ID | Title | Description |
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| OG000 | Menotropin | Menotropins for injection, provided as a vial with powder (75 IU FSH activity and 75 IU LH activity) and a vial with diluent. | | OG001 | Recombinant FSH | Follitropin alpha for injection, human FSH preparation of recombinant DNA origin, provided as pen and cartridges filled with either 300 or 450 IU of FSH activity. |
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| Secondary | Fertilization Rate | Defined as 100 times the ratio of number of fertilized 2 pronuclei oocytes to the number of oocytes retrieved, for each participant. | The mITT analysis set comprised all randomized participants who received at least 1 dose of investigational medicinal product. | Posted | | Mean | Standard Deviation | percentage of each participant | | On day 1 post-insemination | | | | ID | Title | Description |
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| OG000 | Menotropin | Menotropins for injection, provided as a vial with powder (75 IU FSH activity and 75 IU LH activity) and a vial with diluent. | | OG001 | Recombinant FSH | Follitropin alpha for injection, a human FSH preparation of recombinant DNA origin, provided as pen and cartridges filled with either 300 or 450 IU of FSH activity. |
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| Secondary | Quality of Embryos | Assessed by blastomere uniformity, cell size, the degree of fragmentation, and visual signs of multinucleation. | The mITT analysis set comprised all randomized participants who received at least 1 dose of investigational medicinal product. | Posted | | Number | | percentage of embryos | | 3 days after oocyte retrieval | Total number of embryos | Total number of embryos | | ID | Title | Description |
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| OG000 | Menotropin | Menotropins for injection, provided as a vial with powder (75 IU FSH activity and 75 IU LH activity) and a vial with diluent. | | OG001 | Recombinant FSH | Follitropin alpha for injection, a human FSH preparation of recombinant DNA origin, provided as pen and cartridges filled with either 300 or 450 IU of FSH activity. |
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| Secondary | Quality of Embryos | Assessed by cleavage stage. | The mITT analysis set comprised all randomized participants who received at least 1 dose of investigational medicinal product. | Posted | | Mean | Standard Deviation | blastomeres | | 3 days after oocyte retrieval | Total number of blastomere | Total number of blastomere | | ID | Title | Description |
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| OG000 | Menotropin | Menotropins for injection, provided as a vial with powder (75 IU FSH activity and 75 IU LH activity) and a vial with diluent. | | OG001 | Recombinant FSH | Follitropin alpha for injection, a human FSH preparation of recombinant DNA origin, provided as pen and cartridges filled with either 300 or 450 IU of FSH activity. |
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| Secondary | Quality of Blastocysts | Assessed by blastocyst expansion and hatching status, blastocyst inner cell mass grading, and trophectoderm grading. The scoring was based on the classification system by Gardner and Schoolcraft, with additional categories for inner cell mass (degenerative or no inner cell mass) and trophectoderm (degenerative or very large cell). | The mITT analysis set comprised all randomized participants who received at least 1 dose of investigational medicinal product. | Posted | | Number | | percentage of embryos | | 5 days after oocyte retrieval | Embryos reaching blastocyst stage | Embryos reaching blastocyst stage | | ID | Title | Description |
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| OG000 | Menotropin | Menotropins for injection, provided as a vial with powder (75 IU FSH activity and 75 IU LH activity) and a vial with diluent. | | OG001 | Recombinant FSH | Follitropin alpha for injection, a human FSH preparation of recombinant DNA origin, provided as pen and cartridges filled with either 300 or 450 IU of FSH activity. |
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