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NCT06023602·Not applicable·INTERVENTIONAL

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

CetrorelixOtherRecruiting

Status

Recruiting

Phase

Not applicable

Enrollment

1,338

Locations

1

Results

Not posted

Publications

2

Study summary

What the protocol is testing.

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.

Interventions

Treatment arms and agents.

DRUG

Generic cetrorelix acetate

Generic cetrorelix acetate (0.25 mg SC)

DRUG

Reference cetrorelix acetate

reference cetrorelix acetate (0.25 mg SC)

Timeline

From registration to results.

  1. First posted

    Sep 5, 2023

  2. Study start

    Feb 27, 2024

  3. Primary completion

    Dec 1, 2025

  4. Study completion

    Dec 1, 2025

  5. Results posted

    Not reported

  6. Registry updated

    Sep 19, 2025

Outcomes

What the study measures.

Primary outcomes

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)

Secondary outcomes

Not reported in the indexed record.

Eligibility

Who can take part.

Minimum age
20 Years
Maximum age
42 Years
Sex
FEMALE
Healthy volunteers
Yes

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 locations

1 registered sites.

China. Showing up to 24 locations stored in the fast local snapshot.

He Cai

Xi'an, None Selected, China

Publications

Results and literature.

PMID 21774931 ↗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 35595197 ↗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.

Primary links

Continue at the source.

ClinicalTrials.gov ↗Search PubMed ↗Search FDA ↗Search EMA ↗

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Put the record in context.

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TrialsCetrorelix trial dashboard →DatabaseCetrorelix database entry →ResearchCetrorelix research guide →