Comparing generic and reference cetrorelix acetate for ovarian stimulation in IVF

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• He Cai
  Xi'an, None Selected, China Recruiting

Study contacts

• Study coordinator: HE CAI, Doctor
• Email: caihe@bjmu.edu.cn
• Phone: +8613581613908

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.