Actively Recruiting
Effectiveness of Generic Versus Reference Cetrorelix Acetate for Ovarian Stimulation Using a Gonadotropin-releasing Hormone（GnRH）Antagonist Protocol in Women Undergoing IVF
Led by Northwest Women's and Children's Hospital, Xi'an, Shaanxi · Updated on 2025-09-19
1338
Participants Needed
1
Research Sites
91 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Effectiveness of Generic Versus Reference Cetrorelix Acetate for Ovarian Stimulation Using a Gonadotropin-releasing Hormone（GnRH）Antagonist Protocol in Women Undergoing IVF
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Infertile couples planning to undergo IVF or ICSI pregnancy treatment
- Signed informed consent form
- Female participants younger than 43 years old
- Planned use of flexible GnRH antagonist protocol
You will not qualify if you...
- Use of Preimplantation Genetic Testing (PGT)
- Untreated hydrosalpinges, moderate or severe endometriosis, recurrent miscarriage, endometrial pathology, or uterine malformations
- Presence of endocrine diseases such as hyperthyroidism or hyperprolactinemia
- Presence of systemic diseases such as hypertension or diabetes
- Other factors or contraindications deemed inappropriate by the investigator for assisted reproductive technology or pregnancy
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
He Cai
Xi'an, None Selected, China
Actively Recruiting
Research Team
H
HE CAI, Doctor
CONTACT
J
Juanzi Shi, Doctor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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