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

Launched by NORTHWEST WOMEN'S AND CHILDREN'S HOSPITAL, XI'AN, SHAANXI · Aug 30, 2023

Keywords

ClinConnect Summary

This clinical trial is studying the effectiveness of a generic version of a medication called cetrorelix acetate compared to the original version. Both medications are used to help women undergoing in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI) prepare their ovaries for egg retrieval. The main goal is to see if the generic medication works just as well as the original one for stimulating the ovaries when using a specific treatment protocol.

To participate in this trial, women must be under 43 years old and planning to undergo IVF or ICSI, and they need to sign a consent form agreeing to be part of the study. However, women with certain medical conditions, such as significant endometriosis or other serious health issues, cannot join. If eligible, participants can expect to receive daily injections of either the generic or original medication and will be monitored closely during the process. This trial is currently looking for participants, and it aims to provide important information about the safety and effectiveness of the generic medication for fertility treatments.

Gender

FEMALE

Eligibility 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