He Cai
Xi'an, None Selected, China
Location status: Recruiting
Recruiting
NCT Number: NCT06023602
Effectiveness of Generic Versus Reference Cetrorelix Acetate for Ovarian Stimulation Using a Gonadotropin-releasing Hormone（GnRH）Antagonist Protocol in Women Undergoing IVF
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.
Recruiting
Interested in participating?
Request InfoKey information
Conditions
Age range
20 year–42 year
Sex eligibility
Female
Study type
Interventional
Phase
Not applicable
Primary location
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Generic cetrorelix acetate
DrugGeneric cetrorelix acetate (0.25 mg SC)
Reference cetrorelix acetate
Drugreference cetrorelix acetate (0.25 mg SC)
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)
Study contacts
Contact information is provided by the study sponsor or research team.
HE CAI, Doctor
CONTACT
Juanzi Shi, Doctor
CONTACT
Sponsors and collaborators
Lead sponsor
Northwest Women's and Children's Hospital, Xi'an, Shaanxi
Other
Registry information
Official study 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
Important dates
- Study start
- 2024
- Primary completion
- 2025
- Study completion
- 2025
- First posted
- Sep 5, 2023
- Registry last updated
- Sep 19, 2025
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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