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

Официальное название

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

Обзор

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.

Вмешательства

• Препарат Generic cetrorelix acetate
  Generic cetrorelix acetate (0.25 mg SC)
• Препарат Reference cetrorelix acetate
  reference cetrorelix acetate (0.25 mg SC)

Первичные конечные точки

• Cumulative live birth rate [Срок оценки: Through study completion, an average of 18 months]

Критерии участия

Критерии включения

• Infertile couples plan to undergo IVF / ICSI pregnancy treatment into screening procedures and clinical study

• All subjects should sign the informed consent form
• Infertile women <43 years old
• With flexible GnRH antagonist

Критерии исключения

• Subjects could not enter the study if they meet any one of the following criteria

• Preimplantation Genetic Testing (PGT)
• Untreated hydrosalpinges, moderate or severe endometriosis, recurrent spontaneous miscarriage, endometrial pathology, uterine malformations, etc
• Endocrine diseases (such as hyperthyroidism, hyperprolactinemia, etc.) or other systemic disease and other systemic diseases (such as hypertension, diabetes, etc.)．
• Other factors were considered inappropriate by the investigator to participate, or assisted reproductive technology/pregnancy contraindications

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• He Cai — Сиань

Публикации

• 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. PMID 21774931
• 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. PMID 35595197

Идентификаторы

NCT: NCT06023602 · 2023-038

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗