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

Sponsor

Northwest Women's and Children's Hospital, Xi'an, Shaanxi (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06023602

Collaborator

(none)

1,338

Enrollment

Location

Arms

Anticipated Duration (Months)

55.7

Patients Per Site Per Month

Study Details

Study Description

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 biosimilar 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 biosimilar 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: Biosimilar cetrorelix acetate Drug: Reference cetrorelix acetate	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

1338 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Effectiveness of Biosimilar 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

Anticipated Study Start Date :

Nov 1, 2023

Anticipated Primary Completion Date :

Nov 1, 2024

Anticipated Study Completion Date :

Nov 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Biosimilar cetrorelix acetate	Drug: Biosimilar cetrorelix acetate biosimilar cetrorelix acetate (0.25 mg SC)
Active Comparator: Reference cetrorelix acetate	Drug: Reference cetrorelix acetate reference cetrorelix acetate (0.25 mg SC)

Arm

Intervention/Treatment

Experimental: Biosimilar cetrorelix acetate

Drug: Biosimilar cetrorelix acetate

biosimilar cetrorelix acetate (0.25 mg SC)

Active Comparator: Reference cetrorelix acetate

Drug: Reference cetrorelix acetate

reference cetrorelix acetate (0.25 mg SC)

Outcome Measures

Primary Outcome Measures

Cumulative live birth rate [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

Criteria

Ages Eligible for Study:

20 Years to 42 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

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

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

Exclusion Criteria:

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

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	He Cai	Xi'an	None Selected	China

Sponsors and Collaborators

Northwest Women's and Children's Hospital, Xi'an, Shaanxi

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

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:

Sep 5, 2023

Last Update Posted:

Sep 11, 2023

Last Verified:

Sep 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Infertility

Cetrorelix

Study Results

No Results Posted as of Sep 11, 2023