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

ConditionInfertility
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age36-40
SponsorChangchun GeneScience Pharmaceutical Co., Ltd.

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

Qualifiers

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 design

Treatments tested in this trial

  • NA,Observational study

Treatment groups

200 Participants
are divided into 1 treatment group