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

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ClinicalTrials.gov Identifier: NCT06023602
Recruitment Status : Not yet recruiting
First Posted : September 5, 2023
Last Update Posted : November 15, 2023
Sponsor:
Information provided by (Responsible Party):
He Cai, Northwest Women's and Children's Hospital, Xi'an, Shaanxi

Study Description
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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.

Condition or disease Intervention/treatment Phase
Infertility Drug: Generic cetrorelix acetate Drug: Reference cetrorelix acetate Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1338 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Estimated Study Start Date : December 1, 2023
Estimated Primary Completion Date : December 1, 2024
Estimated Study Completion Date : December 1, 2025

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Generic cetrorelix acetate Drug: Generic cetrorelix acetate
Generic cetrorelix acetate (0.25 mg SC)
Active Comparator: Reference cetrorelix acetate Drug: Reference cetrorelix acetate
reference cetrorelix acetate (0.25 mg SC)


Outcome Measures
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Primary Outcome Measures :
  1. Cumulative live birth rate [ Time Frame: Through study completion, an average of 18 months ]
    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)


Eligibility Criteria
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Ages Eligible for Study:   20 Years to 42 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06023602


Contacts
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Contact: HE CAI, Doctor +8613581613908 caihe@bjmu.edu.cn
Contact: Juanzi Shi, Doctor +18602991568 shijuanziart@126.com

Locations
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China, None Selected
He Cai
Xi'an, None Selected, China
Contact: He Cai       caihe@bjmu.edu.cn   
Sponsors and Collaborators
Northwest Women's and Children's Hospital, Xi'an, Shaanxi
More Information
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Publications of Results:

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Responsible Party: He Cai, Principal Investigator, Northwest Women's and Children's Hospital, Xi'an, Shaanxi
ClinicalTrials.gov Identifier: NCT06023602    
Other Study ID Numbers: 2023-038
First Posted: September 5, 2023    Key Record Dates
Last Update Posted: November 15, 2023
Last Verified: November 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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Infertility
Genital Diseases
Urogenital Diseases
Cetrorelix
Fertility Agents, Female
 Fertility Agents
Reproductive Control Agents
Physiological Effects of Drugs
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists