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

Phase 3

Completed

• Conditions: PPOS; GnRH Antagonist; Assisted Reproductive Techniques
• Interventions: Drug: Dydrogesterone Oral Tablet; Drug: Cetrorelix (Cetrotide)

• Registration Number: NCT06868576
• Lead Sponsor: Kasr El Aini Hospital

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.

Study Timeline

• Study Start: 2023-01-03
• Primary Completion: 2024-10-31
• Study First Submitted: 2025-02-18
• Study Completion: 2025-02-28
• Status Verified: 2025-03
• Study First Submitted QC: 2025-03-07
• Last Update Submitted: 2025-03-07
• Study First Posted: 2025-03-11
• Last Update Posted: 2025-03-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 328

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
patients that will undergo progestin primed ovarian stimulation (PPOS) protocol using dydrogesterone	Dydrogesterone Oral Tablet	-
patients that will receive the conventional GnRH antagonist.	Cetrorelix (Cetrotide)	-

Primary Outcome Measures

Name	Time	Method
clinical pregnancy	7 weeks of gestational age	The presence of fetal pulsations by ultrasound at 7 weeks of gestational age

Secondary Outcome Measures

Name	Time	Method
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	Quantitative Beta chorinioic gonadotrophin (B-HCG) hormone levels in blood 2 to 3 weeks after embryo transfer.

Trial Locations

Locations (1)

Ciro University Kasr Alainy OBGYN Hospital; 🇪🇬 Cairo, Alquahira, Egypt