Skip to main content
OpenTrials
Completed

NCT Number: NCT06868576

PPOS Protocol Versus GnRH Anatagonist for Expected Normal Responder Patients Undergoing ART : 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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–39 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Ciro University Kasr Alainy OBGYN Hospital

Cairo, Alquahira, 11835, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Cetrorelix (Cetrotide)

Drug

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

Primary outcomes

  1. clinical pregnancy

    Time frame: 7 weeks of gestational age

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

Secondary outcomes

  1. Incidence of moderate/severe OHSS

    Time frame: before triggering injection and within 9 days after triggering injection

  2. Number of metaphase 2 oocytes

    Time frame: within 1 day of ovum pick up

  3. number of 2 PN embryos

    Time frame: within 1 day of ovum pick up

  4. Biochemical pregnancy

    Time frame: 2-3 weeks after embryo transfer

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

Sponsors and collaborators

Lead sponsor

Kasr El Aini Hospital

Other

Registry information

Official study title

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

Acronym: PPOS vs GnRH

Important dates

Study start
2023
Primary completion
2024
Study completion
2025
First posted
Mar 11, 2025
Registry last updated
Mar 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.