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

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.

Study Overview

• Status: Recruiting
• Conditions: Infertility
• Intervention / Treatment: Drug: Reference cetrorelix acetate; Drug: Generic cetrorelix acetate

• Study Type: Interventional
• Enrollment (Estimated): 1338
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: HE CAI, Doctor; Phone Number: +8613581613908; Email: caihe@bjmu.edu.cn
• Study Contact Backup: Name: Juanzi Shi, Doctor; Phone Number: +18602991568; Email: shijuanziart@126.com

Study Locations

• China
  • None Selected
    • Xi'an, None Selected, China
      • Recruiting
      • He Cai
      • Contact: He Cai; Email: caihe@bjmu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

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

  1. All subjects should sign the informed consent form
  2. Infertile women <43 years old
  3. With flexible GnRH antagonist

Exclusion Criteria:

• Subjects could not enter the study if they meet any one of the following criteria

  1. Preimplantation Genetic Testing (PGT)
  2. Untreated hydrosalpinges, moderate or severe endometriosis, recurrent spontaneous miscarriage, endometrial pathology, uterine malformations, etc
  3. Endocrine diseases (such as hyperthyroidism, hyperprolactinemia, etc.) or other systemic disease and other systemic diseases (such as hypertension, diabetes, etc.)．
  4. Other factors were considered inappropriate by the investigator to participate, or assisted reproductive technology/pregnancy contraindications

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Reference cetrorelix acetate	Drug: Reference cetrorelix acetate; reference cetrorelix acetate (0.25 mg SC)
Experimental: Generic cetrorelix acetate	Drug: Generic cetrorelix acetate; Generic cetrorelix acetate (0.25 mg SC)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

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

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): February 27, 2024
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: August 18, 2023
• First Submitted That Met QC Criteria: August 30, 2023
• First Posted (Actual): September 5, 2023

Study Record Updates

• Last Update Posted (Estimated): September 19, 2025
• Last Update Submitted That Met QC Criteria: September 17, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Infertility; Physiological Effects of Drugs; Hormones, Hormone Substitutes, and Hormone Antagonists; Reproductive Control Agents; Hormone Antagonists; Fertility Agents, Female; Fertility Agents; Cetrorelix
• Other Study ID Numbers: 2023-038

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No