Protocol with Progestin-primed Ovarian Stimulation (PPOS) from the Beginning of Stimulation Versus Protocol with GnRH Antagonists for Ovarian Stimulation in Patients Undergoing DUOSTIM with Embryo Accumulation for PGT-A.

Обзор

The PPOS protocol (Progestin-primed Ovarian Stimulation) involves avoiding ovulation during ovarian stimulation with progesterone. It is a reliable and safe protocol that has been widely used in recent years for in vitro fertilization, as it reduces the number of injections needed during controlled ovarian stimulation and is more cost-effective for patients. The aim of this study is to compare two methods of ovarian stimulation for in vitro fertilization: the PPOS protocol (Group A) and the conventional protocol with injected antagonists (Group B). The goal is to determine whether both methods are equally effective in obtaining euploid embryos in the context of double ovarian stimulation.

Подробное описание

Hypothesis:

Hypothesis: The number of euploid embryos obtained in a DUOSTIM cycle with PPOS is not inferior to that obtained with the use of antagonists.

General and Specific Objectives

Main Objective: To study if there is a difference in the number of euploid embryos obtained in two groups of patients undergoing embryo accumulation for PGT-A through double ovarian stimulation, comparing two methods of pituitary suppression: Progesterone use from the start of stimulation and the use of GnRH antagonists.

Secondary Objectives:

Evaluate if there are differences between both groups regarding the number of MII oocytes.

Evaluate if there are differences between both groups regarding the number of cumulus-oocyte complexes (COC).

Study the differences between both groups regarding the total consumption of gonadotropins.

Evaluate if there are differences between both groups regarding the number of stimulation days.

Evaluate if there are differences in fertilization rate after microinjection. Evaluate if there are differences between both groups regarding the cancellation rate.

Evaluate if there are differences between both groups regarding the number of total embryos.

Evaluate if there are differences between both groups regarding the number of embryos subjected to trophectoderm biopsy.

Вмешательства

• Препарат Ganirelix
  Ganirelix is a GnRH antagonist, which modulates the hypothalamic-pituitary-gonadal axis by competitively binding to GnRH receptors in the pituitary gland. Consequently, there is a reversible, intense, and rapid suppression of endogenous gonadotropin release. Ganirelix is indicated for the prevention of premature luteinizing hormone (LH) surges in women undergoing controlled ovarian hyperstimulation (COH) for assisted reproductive techniques (ART).
• Препарат Medroxyprogesterone Acetate 10 MG
  Medroxyprogesterone acetate is a synthetic progestin (structurally related to progesterone) with antiestrogenic, antiandrogenic, and antigonadotropic action. It inhibits pituitary gonadotropins (FSH and LH) with consequent inhibition of follicular maturation and ovulation . Medroxyprogesterone acetate is active orally and parenterally, 15 times more potent than progesterone. In addition to inhibiting ovulation, progestins also act on the endometrium preventing implantation and increasing the vis

Первичные конечные точки

• Number of Euploid Embryos [Срок оценки: From date of randomization until the end of the treatment. Assessed up to 12 weeks.]

Вторичные конечные точки (4)

• Number of Oocytes retrieved [Срок оценки: From date of randomization until the end of the treatment. Assessed up to 12 weeks.]
• Number of Metaphase II oovcytes [Срок оценки: From date of randomization until the end of the treatment. Assessed up to 12 weeks.]
• Number of Fertilized Oovytes [Срок оценки: From date of randomization until the end of the treatment. Assessed up to 12 weeks.]
• Number of Blastocysts [Срок оценки: From date of randomization until the end of the treatment. Assessed up to 12 weeks.]

Критерии участия

Критерии включения

• Regular menstrual cycles between 21 and 35 days, inclusive.
• Indication of IVF with PGT-A.
• Both ovaries present.
• Ability to participate and complete the study.
• Give and sign the consent to participate in the study.

Критерии исключения

• Endometriosis grade III/IV
• Concurrent participation in another study

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

Открытое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Публикации

• Martinez F, Rodriguez-Purata J, Beatriz Rodriguez D, Clua E, Rodriguez I, Coroleu B. Desogestrel versus antagonist injections for LH suppression in oocyte donation cycles: a crossover study. Gynecol Endocrinol. 2019 Oct;35(10):878-883. doi: 10.1080/09513590.2019.1604661. Epub 2019 May 7. PMID 31062995
• Dong M, Sun L, Huang L, Wang F, Zhang X, Liu F. Fixed Gonadotropin-Releasing Hormone Antagonist Protocol Versus Flexible Progestin-Primed Ovarian Stimulation Protocol in Patients With Asynchronous Follicular Development During Controlled Ovulation Stimulation: A Retrospective Study. Front Endocrinol (Lausanne). 2021 Nov 18;12:690575. doi: 10.3389/fendo.2021.690575. eCollection 2021. PMID 34867773
• Xiao ZN, Peng JL, Yang J, Xu WM. Flexible GnRH Antagonist Protocol versus Progestin-primed Ovarian Stimulation (PPOS) Protocol in Patients with Polycystic Ovary Syndrome: Comparison of Clinical Outcomes and Ovarian Response. Curr Med Sci. 2019 Jun;39(3):431-436. doi: 10.1007/s11596-019-2055-x. Epub 2019 Jun 17. PMID 31209815
• Giles J, Alama P, Gamiz P, Vidal C, Badia P, Pellicer A, Bosch E. Medroxyprogesterone acetate is a useful alternative to a gonadotropin-releasing hormone antagonist in oocyte donation: a randomized, controlled trial. Fertil Steril. 2021 Aug;116(2):404-412. doi: 10.1016/j.fertnstert.2021.02.036. Epub 2021 Apr 2. PMID 33814126
• Begueria R, Garcia D, Vassena R, Rodriguez A. Medroxyprogesterone acetate versus ganirelix in oocyte donation: a randomized controlled trial. Hum Reprod. 2019 May 1;34(5):872-880. doi: 10.1093/humrep/dez034. PMID 30927417
• Wang N, Zhu Q, Ma M, Liang Z, Tao Y, Wang Y, Kuang Y. Comparison of a progestin-primed ovarian stimulation protocol with a flexible GnRH antagonist protocol in patients with polycystic ovary syndrome who are participating in an IVF programme: study protocol for a randomised controlled trial. BMJ Open. 2020 Dec 2;10(12):e038153. doi: 10.1136/bmjopen-2020-038153. PMID 33268401

Идентификаторы

NCT: NCT06637189 · 2306-GFMAD-129-CB · 2023-508769-33

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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