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

This trial does not accept healthy volunteers

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 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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • NA,Observational study

    Other intervention

    Data will be collected without interfering with routine clinical care.

Treatment groups

200 Participants
are divided into 1 treatment group
Group A: Corifollitropin alfa N02 Injection1 intervention

Trial outcomes

Primary outcomes

1

Incidence of treatment-emergent adverse events (TEAEs)

Time frame
From signing the ICF to the birth of the newborn

Secondary outcomes

1

Incidence of early-onset ovarian hyperstimulation syndrome (OHSS)

Time frame
Up to 9 days after triggering of final follicular maturation
2

Incidence of moderate to severe OHSS

Time frame
Up to 10-11 weeks after transfer
3

fetal/newborn birth defects

Time frame
Up to 15 months
4

1-year cumulative clinical pregnancy rate per initiated stimulation cycles

Time frame
4 to 6 weeks after last frozen embryo transfer

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

This trial is not recruiting at the moment. You can still explore other options: