NCT06637189

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.

• Status: Not Yet Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 144 (estimated)
• Sponsor: Ginefiv · Academic / Other
• Sex: Female
• Age: 18 Years – 43 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Stimulation in the Ovary
• Embryo
• Oocyte
• Oocyte Retrieval
• Fertilization in Vitro
• Blastocyst
• PGT-A

Interventions

Type	Name	Description
DRUG	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).
DRUG	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 viscosity of cervical mucus, which hinders sperm progression in the uterus. It also transforms a proliferative endometrium into a secretory endometrium, provided that the woman has adequate endogenous estrogen levels.

Timeline

• Start date: 2024-10-15
• Primary completion: 2025-06-15
• Completion: 2025-12-31
• First posted: 2024-10-15
• Last updated: 2024-10-15