PPOS Protocol Versus GnRH Anatagonist for Expected Normal Responder Patients Undergoing ART : a Randomized Clinical Trial

NCT ID: NCT06868576

Last Updated: 2025-03-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 328 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-03
• Study Completion Date: 2025-02-28

Brief Summary

The aim of this study is to compare the efficacy and safety of Progestin-Primed Ovarian Stimulation (PPOS) protocol versus the fixed GnRH antagonist protocol in expected normal responder patients undergoing intracytoplasmic sperm injection (ICSI) with frozen-thawed embryo transfer (FET). By evaluating key clinical outcomes, including ovarian response, embryological parameters, and pregnancy rates, this study seeks to determine the relative advantages and limitations of each protocol.

Detailed Description

In this prospective, non-inferiority trial, we will compare the efficacy and safety of the GnRH antagonist and PPOS protocols in 328 infertile women undergoing ICSI in Kasr Al-Ainy IVF department, Cairo University, Egypt. Before the trial, investigators were required to provide all information related to the clinical trial, including the possible benefits and risks, other therapeutic choices and the right to withdraw, via a written consent. After being provided with sufficient time to decide whether to participate and the opportunity to ask questions, all participants were required to provide written informed consent before study inclusion.

Conditions

PPOS; GnRH Antagonist; Assisted Reproductive Techniques

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

patients that will undergo progestin primed ovarian stimulation (PPOS) protocol using dydrogesterone

Group Type: EXPERIMENTAL

Dydrogesterone Oral Tablet

Intervention Type: DRUG

Dydrogesterone 20mg tablets daily in PPOS protocol in ovarian stimulation starting from day 2 or 3 of the menstrual cycle until the triggering day

patients that will receive the conventional GnRH antagonist.

Group Type: ACTIVE_COMPARATOR

Cetrorelix (Cetrotide)

Intervention Type: DRUG

This will be the conventional antagonist in ovarian stimulation given from day 6 of the menstrual cycle until the triggering day

Interventions

Dydrogesterone Oral Tablet

Dydrogesterone 20mg tablets daily in PPOS protocol in ovarian stimulation starting from day 2 or 3 of the menstrual cycle until the triggering day

Intervention Type: DRUG

Cetrorelix (Cetrotide)

This will be the conventional antagonist in ovarian stimulation given from day 6 of the menstrual cycle until the triggering day

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• • Women who had history of infertility for ≥1 year.

• Women whose age <40 years old by the end of the study.
• Anti-Mullerian hormone > 1.2 ng/ml.
• Antral follicle count ≥ 5.

Exclusion Criteria

• • Age ≥ 40 years old.

• Women who are diagnosed as polycystic ovarian syndrome.
• Women with endometriosis stage 3 or 4.
• Documented previous IVF/ICSI cycles with no oocytes retrieved.
• Women with contraindications to controlled ovarian stimulation.
• Patients who refuse to share in the study.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 39 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Kasr El Aini Hospital

OTHER

Sponsor Role: lead

Responsible Party

Ahmed Hassan Badawy Gadallah

Dr

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Ciro University Kasr Alainy OBGYN Hospital

Cairo, Alquahira, Egypt

Countries

Egypt

Other Identifiers

MD-10-2023

Identifier Type: -

Identifier Source: org_study_id