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)

October 10, 2024 updated by: Ginefiv

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

144

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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
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.
Active Comparator: 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
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Euploid Embryos
Time Frame: From date of randomization until the end of the treatment. Assessed up to 12 weeks.
Total number of euploid embryos after the two egg retrievals
From date of randomization until the end of the treatment. Assessed up to 12 weeks.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Oocytes retrieved
Time Frame: From date of randomization until the end of the treatment. Assessed up to 12 weeks.
Total number of oocytes retrieved after the two egg retrievals
From date of randomization until the end of the treatment. Assessed up to 12 weeks.
Number of Metaphase II oovcytes
Time Frame: From date of randomization until the end of the treatment. Assessed up to 12 weeks.
Total number of metaphase II oocytes retrieved after the two egg retrievals
From date of randomization until the end of the treatment. Assessed up to 12 weeks.
Number of Fertilized Oovytes
Time Frame: From date of randomization until the end of the treatment. Assessed up to 12 weeks.
Total number of fertilized oocytes after the two egg retrievals
From date of randomization until the end of the treatment. Assessed up to 12 weeks.
Number of Blastocysts
Time Frame: From date of randomization until the end of the treatment. Assessed up to 12 weeks.
Total number of blastocyst stage embryos after the two egg retrievals
From date of randomization until the end of the treatment. Assessed up to 12 weeks.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ginefiv

Collaborators

Theramex

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

October 15, 2024

Primary Completion (Estimated)

June 15, 2025

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

April 25, 2024

First Submitted That Met QC Criteria

October 9, 2024

First Posted (Actual)

October 15, 2024

Study Record Updates

Last Update Posted (Actual)

October 15, 2024

Last Update Submitted That Met QC Criteria

October 10, 2024

Last Verified

September 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2306-GFMAD-129-CB
  • 2023-508769-33 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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