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This study is a multi-center, randomized, double-blind, positive drug-controlled, non-inferiority Phase III clinical trial. The study will enroll approximately 316 infertile female subjects undergoing controlled ovarian hyperstimulation (COH) for in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI) treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental group | Experimental |
| |
| Control group | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SHR7280;Ganirelix Acetate Injection simulant | Drug | SHR7280 200mg Q12h and Ganirelix Acetate Injection simulant 0.5mL qd; |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of oocyte retrieved per COH cycle | number of oocytes obtained after one COH cycle; | On oocyte retrieval 1 day |
| Inhibition rate of premature LH surge | premature LH surge is defined as: LH ≥ 10 IU/L and progesterone P ≥ 1 ng/mL (3.18 nmol/L); | the hCG injection 1 day |
| Measure | Description | Time Frame |
|---|---|---|
| 2PN rate | number of 2 pronuclei(2PN) oocytes/ number of oocytes retrieved or number of MII oocytes×100%; | 16-18 hours (h) after fertilization |
| High quality embryo rate | number of high-quality embryos/ cleavage number×100%; |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University Third Hospital | Beijing | Beijing Municipality | 100191 | China |
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| SHR7280 simulant; Ganirelix Acetate Injection | Drug | SHR7280 simulant 200mg Q12h and Ganirelix Acetate Injection 0.5mL:0.25mg qd; |
|
| 3 days after fertilization |
| Chemical pregnancy rate | number of pregnancy cycles/ number of transplantation cycles×100%; | on chemical pregnancy test 1 day |
| Clinical pregnancy rate | number of clinical pregnancy cycles/ number of transplantation cycles×100%; | on clinical pregnancy test 1 day |
| Persistent pregnancy rate | number of clinical pregnancy cycles/ number of transplantation cycles×100%; | on persistent pregnancy test 1 day |
| Adverse drug events | Day 1 to persistent pregnancy test day/ or End-of-trial visit 1 day |