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

Northwest Women's and Children's Hospital, Xi'an, Shaanxi

Status: Enrolling

Conditions: Infertility

Treatments: Drug: Reference cetrorelix acetate; Drug: Generic cetrorelix acetate

Study type: Interventional

Funder types: Other

Identifiers

NCT06023602

2023-038

Details and patient eligibility

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.

Enrollment: 1,338 estimated patients

Sex: Female

Ages: 20 to 42 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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1,338 participants in 2 patient groups

Generic cetrorelix acetate

Experimental group

Treatment:

Drug: Generic cetrorelix acetate

Reference cetrorelix acetate

Active Comparator group

Treatment:

Drug: Reference cetrorelix acetate