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

Infertility Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06023602
• Other study ID #: 2023-038
• Status: Not yet recruiting
• Phase: N/A
• Start date: December 1, 2023
• Est. completion date: December 1, 2025

Study information

• Verified date: November 2023
• Source: Northwest Women's and Children's Hospital, Xi'an, Shaanxi
• Contact: HE CAI, Doctor
• Phone: +8613581613908
• Email: caihe[@]bjmu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1338
• Est. completion date: December 1, 2025
• Est. primary completion date: December 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 42 Years

Eligibility

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

Related Conditions & MeSH terms

• Infertility

Intervention

Drug:
• Generic cetrorelix acetate
Generic cetrorelix acetate (0.25 mg SC)
• Reference cetrorelix acetate
reference cetrorelix acetate (0.25 mg SC)

Locations

Country	Name	City	State
China	He Cai	Xi'an	None Selected

Sponsors (1)

Lead Sponsor	Collaborator
Northwest Women's and Children's Hospital, Xi'an, Shaanxi

Country where clinical trial is conducted

China, 

References & Publications (2)

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): — View Citation

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):180 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cumulative live birth rate	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)	Through study completion, an average of 18 months