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This is a multi-centre, single-arm, observational trial to assess the safety and efficacy of corifollitropin alfa N02 Injection in elderly Chinese women undergoing ART, and then to explore the compliance and satisfaction during COS treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Corifollitropin alfa N02 Injection | Observe and record the safety and efficacy data of women receiving controlled ovarian stimulation therapy using Corifollitropin alfa N02 Injection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NA,Observational study | Other | Data will be collected without interfering with routine clinical care. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of treatment-emergent adverse events (TEAEs) | From signing the ICF to the birth of the newborn |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of early-onset ovarian hyperstimulation syndrome (OHSS) | Up to 9 days after triggering of final follicular maturation | |
| Incidence of moderate to severe OHSS | Up to 10-11 weeks after transfer |
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Inclusion Criteria:
Exclusion Criteria:
≥3 previous cycles of controlled ovarian stimulation (COS)
Recurrent pregnancy loss: ≥3 previous pregnancy losses (including spontaneous abortion, biochemical pregnancy, and missed abortion).
Repeated implantation failure: ≥3 embryo transfer cycles (fresh or frozen) or failure to achieve clinical pregnancy after transfer of ≥4 high-quality embryos in total.
High risk of ovarian hyperstimulation syndrome (OHSS), defined by any of the following:
Diagnosed with polycystic ovary syndrome (PCOS);
Poor ovarian function, defined by any of the following:
① Previous poor ovarian response (≤3 oocytes retrieved following conventional full-dose gonadotropin stimulation);
② Total AFC in both ovaries <5.
Presence of any reproductive, endocrine, or immune disorders that may affect pregnancy, as assessed by the investigator.
Abnormal uterine bleeding.
Presence of systemic diseases (e.g., cardiovascular, digestive, neurological, hematological disorders) deemed unsuitable for study participation by the investigator, or severe diseases incompatible with pregnancy.
Hypersensitivity or history of allergy to active ingredients or excipients of gonadotropins (Gn), GnRH antagonists, or progesterone preparations, or with documented contraindications to these medications.
History of alcoholism, heavy smoking, drug addiction, or substance abuse.
Scheduled to undergo preimplantation genetic testing (PGT).
Currently participating in another clinical trials and receiving investigational products.
Any other conditions deemed by the investigator to render the subject unsuitable for trial participation based on safety considerations.
This study evaluated the safety and efficacy of Corifollitropin alfa N02 injection in at least 200 Chinese women aged 36-40 undergoing assisted reproductive technology (ART).
Married women aged 35-39 years scheduled for controlled ovarian stimulation (COS) and IVF/ICSI assisted reproduction using a fixed antagonist protocol with Corifollitropin alfa N02 Injection.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mengsheng Zhang | Contact | +86 18190952182 | zhangmengsheng@genscigroup.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University Third Hospital | Beijing | Beijing Municipality | 100191 | China |
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| ID | Term |
|---|---|
| D007246 | Infertility |
| ID | Term |
|---|---|
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
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| fetal/newborn birth defects | Up to 15 months |
| 1-year cumulative clinical pregnancy rate per initiated stimulation cycles | 4 to 6 weeks after last frozen embryo transfer |
| 1-year cumulative ongoing pregnancy rate per initiated stimulation cycles | 9 to 11 weeks after last frozen embryo transfer |
| 1-year cumulative live birth rate per initiated stimulation cycles | more than 40 weeks after last frozen embryo transfer |
| β-hCG/hCG positive rate per initiated stimulation cycles with fresh embryo transfer | 4 weeks after fresh embryo transfer |
| Clinical pregnancy rate per initiated stimulation cycles with fresh embryo transfer | 4 to 6 weeks after fresh embryo transfer |
| Ongoing pregnancy rate per initiated stimulation cycles with fresh embryo transfer | 9 to 11 weeks after fresh embryo transfer |
| Live birth rate per initiated stimulation cycles with fresh embryo transfer | more than 40 weeks after fresh embryo transfer |
| β-hCG/hCG positive rate per initiated stimulation cycles with first embryo transfer cycle | 4 weeks after first embryo transfer |
| Clinical pregnancy rate per initiated stimulation cycles with first embryo transfer cycle | 4 to 6 weeks after first embryo transfer |
| Ongoing pregnancy rate per initiated stimulation cycles with first embryo transfer cycle | 9 to 11 weeks after first embryo transfer |
| Live birth rate per initiated stimulation cycles with first embryo transfer cycle | more than 40 weeks after first embryo transfer |
| Pregnancy loss rate | Up to 38 weeks after transfer |
| Number of oocytes retrieved | Up to 22 days |
| Estrogen (E₂) and progesterone (P) levels during controlled ovarian stimulation (COS) | Up to 22 days |
| Follicular development status | Up to 22 days |
| Metaphase II (MII) oocyte rate [evaluated only in intracytoplasmic sperm injection (ICSI) cycles] | Up to 22 days |
| Fertilization rate Implantation rate | Day 3 after oocyte retrieval |
| Implantation rate | Up to 28 days |
| High-quality embryo rate | Day 3 after oocyte retrieval |
| Usable blastocyst formation rate | Day 5 after oocyte retrieval |