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.

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE4

Total Enrollment

144 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-10-15

Study Completion Date

2025-12-31

Brief Summary

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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.

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Detailed Description

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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

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This is a prospective, randomized non-inferiority study. There will be two groups of patients:

Patients in Group A (PPOS protocol - study group) will start controlled ovarian stimulation with the administration of FSHr gonadotropin at doses between 225 IU-300 IU/day (depending on patient characteristics) + 10 mg medroxyprogesterone/day (IMP).

Patients in Group B (Short protocol with GnRH antagonists - control group) will start controlled ovarian stimulation with the administration of FSHr gonadotropin at doses between 225 IU-300 IU/day (depending on patient characteristics) and will add treatment with a GnRH antagonist at a dose of 0.25 mg/day from the 6th day of stimulation or when a follicle with a size equal to or greater than 14 mm is present.

Once the two stimulations typical of the DuoStim strategy are completed, the results obtained in both groups will be compared.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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PPOS - study group

Patients belonging to this arm will initiate controlled ovarian stimulation by administering FSHr gonadotropin at doses between 225 IU-300 IU/day (according to patient characteristics) + 10mg medroxyprogesterone/day (IMP) from day 2-3 of their menstrual cycle.

Both groups will continue with the usual regimen of administration of all medications related to Ovarian Stimulation

Group Type EXPERIMENTAL

Medroxyprogesterone Acetate 10 MG

Intervention Type DRUG

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.

GnRH antagonists - control group

Patients belonging to this arm will initiate controlled ovarian stimulation by administering FSHr gonadotropin at doses between 225 IU-300 IU/day (according to patient characteristics) from day 2-3 of their menstrual cycle, and treatment with the GnRH antagonist at a dose of 0.25 mg/day from the 6th day of stimulation or when a follicle with a size equal to or greater than 14mm is present. Both groups will continue with the usual regimen of administration of all medications related to Ovarian Stimulation

Group Type ACTIVE_COMPARATOR

Ganirelix

Intervention Type DRUG

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).

Interventions

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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).

Intervention Type 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.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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.