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

NCT06023602 | Recruiting DMC

• 1 other identifier: 2023-038
• Study Type: interventional
• Target: 1,338
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Cumulative live birth rate

  For the first live birth (gestation≥ 24 weeks) in one in vitro fertilization/intracytoplasmic sperm injection egg retrieval cycle (fresh and frozen-thawed embryo transfer cycle)

  Through study completion, an average of 18 months

Study Arms (2)

Generic cetrorelix acetate

EXPERIMENTAL

Drug: Generic cetrorelix acetate

Reference cetrorelix acetate

ACTIVE COMPARATOR

Drug: Reference cetrorelix acetate

Interventions

Generic cetrorelix acetate DRUG

Generic cetrorelix acetate (0.25 mg SC)

Generic cetrorelix acetate

Reference cetrorelix acetate DRUG

reference cetrorelix acetate (0.25 mg SC)

Reference cetrorelix acetate

Eligibility Criteria

• Age: 20 Years - 42 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Subjects could not enter the study if they meet any one of the following criteria
• Preimplantation Genetic Testing (PGT)
• Untreated hydrosalpinges, moderate or severe endometriosis, recurrent spontaneous miscarriage, endometrial pathology, uterine malformations, etc
• Endocrine diseases (such as hyperthyroidism, hyperprolactinemia, etc.) or other systemic disease and other systemic diseases (such as hypertension, diabetes, etc.)．
• Other factors were considered inappropriate by the investigator to participate, or assisted reproductive technology/pregnancy contraindications

Sponsors & Collaborators

• Northwest Women's and Children's Hospital, Xi'an, Shaanxi: lead

Study Sites (1)

He Cai

Xi'an, None Selected, China

RECRUITING

Related Publications (2)

• Dovey S, McIntyre K, Jacobson D, Catov J, Wakim A. Is a premature rise in luteinizing hormone in the absence of increased progesterone levels detrimental to pregnancy outcome in GnRH antagonist in vitro fertilization cycles. Fertil Steril. 2011 Sep;96(3):585-9. doi: 10.1016/j.fertnstert.2011.06.042. Epub 2011 Jul 20.

  PMID: 21774931 BACKGROUND

• Liu X, Wen W, Wang T, Tian L, Li N, Sun T, Wang T, Zhou H, Zhang N, Qu P, Mol BW, Li W, Shi J. Increased versus standard gonadotrophin dosing in predicted poor responders of IVF: an open-label randomized controlled trial. Hum Reprod. 2022 Jul 30;37(8):1806-1815. doi: 10.1093/humrep/deac113.

  PMID: 35595197 BACKGROUND

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Central Study Contacts

HE CAI, Doctor

CONTACT

+8613581613908; caihe@bjmu.edu.cn

Juanzi Shi, Doctor

CONTACT

+18602991568; shijuanziart@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 18, 2023
• First Posted: September 5, 2023
• Study Start: February 27, 2024
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: September 19, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)