Comparing generic and reference cetrorelix acetate for ovarian stimulation in IVF
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
This study is testing if a generic version of cetrorelix acetate works just as well as the brand-name version for women undergoing IVF treatment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 1338 (estimated) |
| Ages | 20 Years to 42 Years |
| Sex | Female |
| Sponsor | Northwest Women's and Children's Hospital, Xi'an, Shaanxi Academic / other |
| Locations | 1 site (Xi'an, None Selected) |
| Trial ID | NCT06023602 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of generic cetrorelix acetate compared to the reference product in women undergoing in vitro fertilization (IVF) using a gonadotropin-releasing hormone (GnRH) antagonist protocol. Participants will receive either the generic or reference cetrorelix acetate during ovarian stimulation, with the primary focus on determining if the generic version is non-inferior in terms of clinical outcomes. The study will involve administering a daily dose of 0.25 mg of cetrorelix acetate once the lead follicle reaches 14 mm, followed by triggering oocyte maturation when multiple follicles reach 17 mm. The trial is designed to provide insights into the viability of using a generic medication in assisted reproductive technology.
Who should consider this trial
Good fit: Ideal candidates for this study are infertile women under 43 years old who are planning to undergo IVF or intracytoplasmic sperm injection (ICSI).
Not a fit: Patients with untreated hydrosalpinges, severe endometriosis, or other significant reproductive health issues may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a cost-effective alternative to the reference cetrorelix acetate for women undergoing IVF, potentially improving access to fertility treatments.
How similar studies have performed: Other studies have shown promising results with the use of generic medications in fertility treatments, suggesting that this approach may be viable.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Xi'an, None Selected
- He Cai — Xi'an, None Selected, China (Recruiting)
Study contacts
- Study coordinator: HE CAI, Doctor
- Email: caihe@bjmu.edu.cn
- Phone: +8613581613908
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.