About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
≥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.
Diagnosed with polycystic ovary syndrome (PCOS);
Trial population
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.
Trial design
Cohort
Prospective
Treatments tested in this trial
NA,Observational study
Other interventionData will be collected without interfering with routine clinical care.
Treatment groups
Trial outcomes
Primary outcomes
Incidence of treatment-emergent adverse events (TEAEs)
Secondary outcomes
Incidence of early-onset ovarian hyperstimulation syndrome (OHSS)
Incidence of moderate to severe OHSS
fetal/newborn birth defects
1-year cumulative clinical pregnancy rate per initiated stimulation cycles
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
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