Safety and Efficacy of Corifollitropin Alfa N02 Injection in Elderly Women Undergoing Assisted Re… (NCT07553728) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Safety and Efficacy of Corifollitropin Alfa N02 Injection in Elderly Women Undergoing Assisted Reproductive Technology (ART)
China200 participantsStarted 2026-05-01
Plain-language summary
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.
Who can participate
Age range36 Years – 40 Years
SexFEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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)
✕. 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:
✕. Poor ovarian function, defined by any of the following:
✕. Presence of any reproductive, endocrine, or immune disorders that may affect pregnancy, as assessed by the investigator.
✕. Abnormal uterine bleeding.
✕
What they're measuring
1
Incidence of treatment-emergent adverse events (TEAEs)
Timeframe: From signing the ICF to the birth of the newborn
. 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.