Clinical Trial

Effectiveness of Generic Versus Reference Cetrorelix Acetate for Ovarian Stimulation Using a Gonadotropin-releasing Hormone（GnRH）Antagonist Protocol in Women Undergoing IVF

Recruiting
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Record status
This record was last updated September 19, 2025 (before its estimated December 1, 2025 completion). Its status may not reflect the trial's current state.
Summary
The goal of this clinical trial is to compare the clinical outcomes using different cetrorelix acetate in the context of a GnRH antagonist protocol for ovarian stimulation in women undergoing IVF or intracytoplasmic sperm injection(ICSI) treatment.The main question it aims to answer is whether the generic cetrorelix acetate is non-inferior to the reference product in the GnRH antagonist based protocol for women undergoing IVF. Ovarian stimulation was achieved by several types of follicle-stimulating hormone(FSH) or by FSH combined with luteinizing hormone activity. Daily dose of generic cetrorelix acetate (0.25 mg SC) or original cetrorelix acetate (0.25 mg SC) will be administered when the lead follicle was 14 mm. When more than two follicles reached 17 mm, oocyte maturation was triggered with 250 mcg of recombinant human chorionic gonadotropin.
Protocol Amendment History 5 amendments
This ClinicalTrials.gov record has been amended 5 times since 2023-08-30; most recent amendment 2025-09-17.
Status change: Not Yet Recruiting → Recruiting 2024-07-09
Trial Details
NCT Number NCT06023602
Lead Sponsor Northwest Women's and Children's Hospital, Xi'an, Shaanxi
Conditions Infertility
Enrollment 1,338 participants
Start Date 2024-02-27
Primary Completion 2025-12-01 (estimated)
Study Completion 2025-12-01 (estimated)
Updated on ClinicalTrials.gov 2025-09-19