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

Kasr El Aini Hospital

Status and phase: Completed; Phase 3

Conditions: GnRH Antagonist; PPOS; Assisted Reproductive Techniques

Treatments: Drug: Dydrogesterone Oral Tablet; Drug: Cetrorelix (Cetrotide)

Study type: Interventional

Funder types: Other

Identifiers

NCT06868576

MD-10-2023

Details and patient eligibility

About

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.

Full 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.

Enrollment: 328 patients

Sex: Female

Ages: 18 to 39 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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328 participants in 2 patient groups

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

Experimental group

Treatment:

Drug: Dydrogesterone Oral Tablet

patients that will receive the conventional GnRH antagonist.

Active Comparator group

Treatment:

Drug: Cetrorelix (Cetrotide)