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

Last updated: July 9, 2024
Sponsor: Northwest Women's and Children's Hospital, Xi'an, Shaanxi
Overall Status: Active - Recruiting

Phase

N/A

Condition

Infertility

Treatment

Biosimilar cetrorelix acetate

Reference cetrorelix acetate

Generic cetrorelix acetate

Clinical Study ID

NCT06023602
2023-038
  • Ages 20-42
  • Female
  • Accepts Healthy Volunteers

Study 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 Criteria

Inclusion

Inclusion Criteria:

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

  1. All subjects should sign the informed consent form

  2. Infertile women <43 years old

  3. With flexible GnRH antagonist

Exclusion

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, recurrentspontaneous miscarriage, endometrial pathology, uterine malformations, etc

  3. Endocrine diseases (such as hyperthyroidism, hyperprolactinemia, etc.) or othersystemic 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 Design

Total Participants: 1338
Treatment Group(s): 3
Primary Treatment: Biosimilar cetrorelix acetate
Phase:
Study Start date:
February 27, 2024
Estimated Completion Date:
December 01, 2025

Connect with a study center

  • He Cai

    Xi'an, None Selected
    China

    Active - Recruiting

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