NCT06023602

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

Effectiveness of Generic Cetrorelix Acetate Versus Reference Cetrorelix Acetate for Ovarian Stimulation Using a GnRH Antagonist Protocol in Women Undergoing IVF: A Multicenter Non-inferiority, Randomised Controlled Trial

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,338 (estimated)
• Sponsor: Northwest Women's and Children's Hospital, Xi'an, Shaanxi · Academic / Other
• Sex: Female
• Age: 20 Years – 42 Years
• Healthy volunteers: Accepted

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.

Conditions

• Infertility

Interventions

Type	Name	Description
DRUG	Generic cetrorelix acetate	Generic cetrorelix acetate (0.25 mg SC)
DRUG	Reference cetrorelix acetate	reference cetrorelix acetate (0.25 mg SC)

Timeline

• Start date: 2024-02-27
• Primary completion: 2025-12-01
• Completion: 2025-12-01
• First posted: 2023-09-05
• Last updated: 2025-09-19

Locations

1 site across 1 country: China