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

NCT06868576 | Completed Phase 3

• 1 other identifier: MD-10-2023
• Study Type: interventional
• Target: 328
• Locations: 1 country
• Sites: 1

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.

Conditions

PPOS; GnRH Antagonist; Assisted Reproductive Techniques

Outcome Measures

Primary Outcomes (1)

• clinical pregnancy

  The presence of fetal pulsations by ultrasound at 7 weeks of gestational age

  7 weeks of gestational age

Secondary Outcomes (4)

• Incidence of moderate/severe OHSS

  before triggering injection and within 9 days after triggering injection

• Number of metaphase 2 oocytes

  within 1 day of ovum pick up

• number of 2 PN embryos

  within 1 day of ovum pick up

• Biochemical pregnancy

  2-3 weeks after embryo transfer

Study Arms (2)

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

EXPERIMENTAL

Drug: Dydrogesterone Oral Tablet

patients that will receive the conventional GnRH antagonist.

ACTIVE COMPARATOR

Drug: Cetrorelix (Cetrotide)

Interventions

Dydrogesterone Oral Tablet 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 undergo progestin primed ovarian stimulation (PPOS) protocol using dydrogesterone

Cetrorelix (Cetrotide) DRUG

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

patients that will receive the conventional GnRH antagonist.

Eligibility Criteria

• Age: 18 Years - 39 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kasr El Aini Hospital: lead

Study Sites (1)

Ciro University Kasr Alainy OBGYN Hospital

Cairo, Alquahira, 11835, Egypt

Location

MeSH Terms

Interventions

Dydrogesterone; cetrorelix

Intervention Hierarchy (Ancestors)

Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Model Details: Three hundred twenty-eight women will be divided into 2 groups (A and B), each group will consist of 164 patients: \*Group A (Study group): Includes 164 patients that will undergo progestin primed ovarian stimulation (PPOS) protocol using dydrogesterone. \*Group B (control group): Includes 164 patients that will receive the conventional GnRH antagonist.

Study Record Dates

• First Submitted: February 18, 2025
• First Posted: March 11, 2025
• Study Start: January 3, 2023
• Primary Completion: October 31, 2024
• Study Completion: February 28, 2025
• Last Updated: March 11, 2025

Record last verified: 2025-03

Locations

EG (1)