Clinical trial NCT06023602: Effectiveness of Generic Versus Reference Cetrorelix Acetate for Ovarian Stimulation Using a Gonadotropin-releasing Hormone（GnRH）Antagonist Protocol in Women Undergoing IVF
Official 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Infertility
Lead sponsor: Northwest Women's and Children's Hospital, Xi'an, Shaanxi
Sponsor class: OTHER
First posted: 2023-09-05
Enrollment: 1338
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 42
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


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

Primary outcomes:
measure: Cumulative live birth rate
timeFrame: Through study completion, an average of 18 months
Secondary outcomes:
Other outcomes:
Locations:
city: Xi'an
country: China
facility: He Cai
state: None Selected
Study officials:
References:
citation: Dovey S, McIntyre K, Jacobson D, Catov J, Wakim A. Is a premature rise in luteinizing hormone in the absence of increased progesterone levels detrimental to pregnancy outcome in GnRH antagonist in vitro fertilization cycles. Fertil Steril. 2011 Sep;96(3):585-9. doi: 10.1016/j.fertnstert.2011.06.042. Epub 2011 Jul 20.
citation: Liu X, Wen W, Wang T, Tian L, Li N, Sun T, Wang T, Zhou H, Zhang N, Qu P, Mol BW, Li W, Shi J. Increased versus standard gonadotrophin dosing in predicted poor responders of IVF: an open-label randomized controlled trial. Hum Reprod. 2022 Jul 30;37(8):1806-1815. doi: 10.1093/humrep/deac113.