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. (PPDUO)

Ginefiv

Status and phase: Not yet enrolling; Phase 4

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

Treatments: Drug: Ganirelix; Drug: Medroxyprogesterone Acetate 10 MG

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06637189

2023-508769-33 (EudraCT Number)

2306-GFMAD-129-CB

Details and patient eligibility

About

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.

Full 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.

Enrollment: 144 estimated patients

Sex: Female

Ages: 18 to 43 years old

Volunteers: Accepts Healthy Volunteers

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.

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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144 participants in 2 patient groups

PPOS - study group

Experimental group

Description:

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

Treatment:

Drug: Medroxyprogesterone Acetate 10 MG

GnRH antagonists - control group

Active Comparator group

Description:

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

Treatment:

Drug: Ganirelix