Safety and Efficacy of Corifollitropin Alfa N02 Injection in Elderly Women Undergoing Assisted Reproductive Technology (ART)

Inclusion criteria

• 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.

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);

• 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 <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.