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

Sponsor
Changchun GeneScience Pharmaceutical Co., Ltd.
Study ID
NCT07553728
Status
Not Yet Recruiting

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Conditions

  • Infertility

Eligibility Criteria

Sex
FEMALE
Age
36 Years - 40 Years
Healthy Volunteers
Not accepted

Interventions

  • NA，Observational study — OTHER
    Data will be collected without interfering with routine clinical care.

Study Details

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.

Key Dates

First listed
Apr 28, 2026
Start date
May 1, 2026
Status verified
Mar 2026
Primary completion
Aug 4, 2029
Completion
Dec 16, 2029

Study Design

Enrollment
200 participants (estimated)

Arms

  • Arm: Corifollitropin alfa N02 Injection
    Observe and record the safety and efficacy data of women receiving controlled ovarian stimulation therapy using Corifollitropin alfa N02 Injection

Primary Outcome Measure

Incidence of treatment-emergent adverse events (TEAEs) [ Time Frame: From signing the ICF to the birth of the newborn ]

Central Contacts

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