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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

1338 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-02-27

Study Completion Date

2025-12-01

Brief Summary

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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.

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Detailed Description

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Conditions

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Infertility

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Generic cetrorelix acetate

Group Type EXPERIMENTAL

Generic cetrorelix acetate

Intervention Type DRUG

Generic cetrorelix acetate (0.25 mg SC)

Reference cetrorelix acetate

Group Type ACTIVE_COMPARATOR

Reference cetrorelix acetate

Intervention Type DRUG

reference cetrorelix acetate (0.25 mg SC)

Interventions

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Generic cetrorelix acetate

Generic cetrorelix acetate (0.25 mg SC)

Intervention Type DRUG

Reference cetrorelix acetate

reference cetrorelix acetate (0.25 mg SC)

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

20 Years

Maximum Eligible Age

42 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes