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

Progestin-Primed Ovarian Stimulation Versus Gonadotrophin-Releasing Hormone Antagonist for Patients Undergoing Assisted Reproductive Technology: a Randomized Clinical Trial

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.

Study Overview

• Status: Completed
• Conditions: GnRH Antagonist; PPOS; Assisted Reproductive Techniques
• Intervention / Treatment: Drug: Dydrogesterone Oral Tablet; Drug: Cetrorelix (Cetrotide)

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 Type: Interventional
• Enrollment (Actual): 328
• Phase: Phase 3

Contacts and Locations

Study Locations

• Egypt
  • Alquahira
    • Cairo, Alquahira, Egypt, 11835
      • Ciro University Kasr Alainy OBGYN Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: patients that will undergo progestin primed ovarian stimulation (PPOS) protocol using dydrogesterone	Drug: 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
Active Comparator: patients that will receive the conventional GnRH antagonist.	Drug: Cetrorelix (Cetrotide); This will be the conventional antagonist in ovarian stimulation given from day 6 of the menstrual cycle until the triggering day

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
clinical pregnancy	The presence of fetal pulsations by ultrasound at 7 weeks of gestational age	7 weeks of gestational age

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Quantitative Beta chorinioic gonadotrophin (B-HCG) hormone levels in blood 2 to 3 weeks after embryo transfer.	2-3 weeks after embryo transfer

Collaborators and Investigators

• Sponsor: Kasr El Aini Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 3, 2023
• Primary Completion (Actual): October 31, 2024
• Study Completion (Actual): February 28, 2025

Study Registration Dates

• First Submitted: February 18, 2025
• First Submitted That Met QC Criteria: March 7, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 7, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Reproductive Control Agents; Hormone Antagonists; Fertility Agents, Female; Fertility Agents; Progestins; Dydrogesterone; Cetrorelix
• Other Study ID Numbers: MD-10-2023

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