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
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 20
Maximum Age: 42
Healthy Volunteers: t
View:

• Infertile couples plan to undergo IVF / ICSI pregnancy treatment into screening procedures and clinical study

‣ All subjects should sign the informed consent form

⁃ Infertile women \<43 years old

⁃ With flexible GnRH antagonist

Locations
Other Locations
China
He Cai
RECRUITING
Xi'an
Contact Information
Primary
HE CAI, Doctor
caihe@bjmu.edu.cn
+8613581613908
Backup
Juanzi Shi, Doctor
shijuanziart@126.com
+18602991568
Time Frame
Start Date: 2024-02-27
Estimated Completion Date: 2025-12-01
Participants
Target number of participants: 1338
Treatments
Experimental: Generic cetrorelix acetate
Active_comparator: Reference cetrorelix acetate
Related Therapeutic Areas
Sponsors
Leads: Northwest Women's and Children's Hospital, Xi'an, Shaanxi

This content was sourced from clinicaltrials.gov