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to compare and evaluate the efficacy and safety of Ganilever PFS and Orgalutran® in infertility women for assisted reproductive technologies
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ganilever (ganirelix acetate) | Experimental | Prefilled syringe / 0.25mg/0.5mL |
|
| Orgalutran (ganirelix acetate) | Active Comparator | Prefilled syringe / 0.25mg/0.5mL |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ganirelix acetate | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of oocytes retrieved | about 10 days after randomization |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of subjects with LH (luteinizing hormone) rise > 10 mIU/mL | about 8~9 days after randomization (visit 4) | |
| Oocyte quality | Day of oocyte retrieval (about 10 days after randomization) | |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHA Bundang Medical Center, CHA University | Gyeonggi-do | South Korea | ||||
| CHA Gangnam Medical Center |
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| ID | Term |
|---|---|
| C061018 | ganirelix |
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| Total administration dosage (IU) of Follitrope® PFS |
| During 8~9 days after randomization (until administration hCG) |
| Total administration duration (day) of Follitrope® PFS | During 8~9 days after randomization (until administration hCG) |
| Total administration dosage (mL) of Ganilever PFS or Orgalutran® | From 4~5 days after randomization to 8~9 days after randomization |
| Total administration duration (day) of Ganilever PFS or Orgalutran® | From 4~5 days after randomization to 8~9 days after randomization |
| Fertilization rate (%) | Day of oocyte retrieval (about 10 days after randomization) |
| Implantation rate (%) | About 4~5 weeks after Embryo transfer |
| Chemical pregnancy (%) | About 2 weeks after oocyte retrieval |
| Clinical pregnancy (%) | About 4~5 weeks after Embryo transfer |
| Ongoing pregnancy (%) | About 10~11 weeks after oocyte retrieval |
| Seoul |
| South Korea |