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| Name | Class |
|---|---|
| Sixth Affiliated Hospital, Sun Yat-sen University | OTHER |
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To investigate the efficacy and safety of a single injection of GenSci094 to induce multi-follicular development for controlled ovarian stimulation using daily recombinant FSH (recFSH) as a reference. The primary hypothesis is that a single injection of GenSci094 is non-inferior to daily treatment with recFSH in initiating multi-follicular growth.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GenSci094 | Experimental | Participants received a single subcutaneous (SC) injection of 150 µg or 100µg GenSci094 on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections from Stimulation Days 1 to 7 with placebo-recFSH; followed by daily SC injections with 150 IU or225IU recFSH up to the day of hCG. Daily SC injections of Ganirelix were administered from Stimulation Day 5 to the day of hCG; at which time a single dose of hCG was given when 3 follicles >= 17 mm. On the day of oocyte pick up (OPU) daily doses of progesterone were started and continued for up to 6 weeks or menses. |
|
| recFSH | Active Comparator | Participants received a single SC injection of placebo GenSci094 on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections with 150 IU or 225IU recFSH from Stimulation Days 1 to 7; followed by daily SC injections with 200 IU recFSH up to the day of hCG. Daily SC injections of Ganirelix were given from Stimulation Day 5 to the day of hCG; at which time a single dose of hCG was administered when 3 follicles >= 17 mm. On the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GenSci094 | Drug | On the morning of day 2 or 3 of the menstrual cycle (Stimulation Day 1), a single SC injection of 150 μg or 100μg (0.5 mL) GenSci094 was administered in the abdominal wall. |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Number of Oocytes Retrieved | Approximately Day 10-14 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With an Ongoing Pregnancy (Ongoing Pregnancy Rate) | Assessed at least 10 weeks after embryo transfer | |
| Percentage of Fertilized Oocytes (Fertilization Rate) | Up to 18 hours after start of fertilization |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| xiaoyan liang, doctor | The Sixth Affiliated Hospital, Sun Yat-sen University Guangdong Gastrointestinal Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Sixth Affiliated Hospital, Sun Yat-sen University Guangdong Gastrointestinal Hospital | Guangzhou | Guangdong | 510610 | China |
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| Placebo RecFSH / follitropin alfa | Drug | powder-injection, but without the active ingedient, SC injection . Daily SC injections were started on Stimulation Day 1 and continued up to and including Stimulation Day 7. |
|
| Biological: RecFSH / Follitropin alfa (Days 1 to 7) | Biological | Daily SC injections with 150IU or 225IU recFSH were started on Stimulation Day 1 and continued up to and including Stimulation Day 7. |
|
| Placebo GenSci094 | Drug | Pre-filled syringe containing an identical solution when compared to GenSci094. On the morning of day 2 or 3 of the menstrual cycle (Stimulation Day 1), a single SC injection was administered in the abdominal wall. |
|
| RecFSH / Follitropin alfa (Days 8 to hCG) | Biological | From Stimulation Day 8 onwards a daily SC dose 75IU～300 IU recFSH was administered up to and including the Day of hCG. |
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| Ganirelix | Drug | On Stimulation Day 5 a daily SC injection of 0.25 mg was started, which continued up to and including the day of hCG |
|
| hCG | Biological | When 3 follicles >= 17 mm were observed by USS, a single dose of 10,000 IU/USP hCG was administered; or, for those at risk for Ovarian Hyperstimulation Syndrome (OHSS), a lower dose of 5,000 IU/USP |
|
| Progesterone | Drug | On the day of OPU, luteal phase support was started by administering micronized progesterone of at least 400 mg/day vaginally, and 40mg/d oral, which continued for at least 6 weeks, or up to menses. |
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| Number of Embryos Obtained on Day 3 Categorized by Quality | Post fertilization Day 3 |
| Percentage of Gestational Sacs (Implantation Rate) | Up to 6 weeks after embryo transfer |
| Percentage of Participants With a Biochemical Pregnancy Per Embryo Transfer | Two weeks after embryo transfe |
| Percentage of Participants With a early miscarriage（early miscarriage rate）Per Clinical Pregnancy | Up to 12 weeks after embryo transfer |
| ID | Term |
|---|---|
| D007246 | Infertility |
| ID | Term |
|---|---|
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| C571801 | follitropin alfa |
| C061018 | ganirelix |
| D011374 | Progesterone |
| ID | Term |
|---|---|
| D011282 | Pregnenediones |
| D011283 | Pregnenes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D003339 | Corpus Luteum Hormones |
| D042341 | Gonadal Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D045167 | Progesterone Congeners |
| D012739 | Gonadal Steroid Hormones |
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