NCT07553728尚未招募不适用
A Multi-center, Single-arm, Observational Study to Assess the Safety and Efficacy of Corifollitropin Alfa N02 Injection in Elderly Women Undergoing Assisted Reproductive Technology (ART)
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Incidence of treatment-emergent adverse events (TEAEs)
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 36 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Able to communicate well with investigators, understand and comply with trial requirements, participate voluntarily, and provide signed informed consent after full understanding.
- •Married women aged 36 to 40 years (exclusive of boundary values).
- •Normal ovarian function: AMH ≥ 1.1 μg/L and basal FSH < 10 IU/L.
- •Scheduled to undergo controlled ovarian stimulation (COS) and IVF/ICSI using a fixed antagonist protocol combined with Corifollitropin alpha N02 injection.
排除标准
- •≥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);
- •Total number of AFC in both ovaries >20 on Day 2-3 of menstruation; ③ Previous cycle cancellation (including canceled embryo transfer) due to high ovarian response or high OHSS risk; ④ History of OHSS; ⑤ Other conditions judged by the investigator to confer high OHSS risk after comprehensive evaluation.
- •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 <
- •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.
研究组 & 干预措施
Corifollitropin alfa N02 Injection
Observe and record the safety and efficacy data of women receiving controlled ovarian stimulation therapy using Corifollitropin alfa N02 Injection
干预措施: NA，Observational study (Other)
结局指标
主要结局
Incidence of treatment-emergent adverse events (TEAEs)
时间窗: From signing the ICF to the birth of the newborn
次要结局
- Incidence of moderate to severe OHSS(Up to 10-11 weeks after transfer)
- 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)
- Incidence of early-onset ovarian hyperstimulation syndrome (OHSS)(Up to 9 days after triggering of final follicular maturation)
- 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)
研究者
研究点 (1)
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