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

Kasr El Aini Hospital328 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

328

Conditions

PPOS GnRH Antagonist

Interventions

Dydrogesterone Oral TabletDRUG

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

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 39 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

clinical pregnancy

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

Time frame: 7 weeks of gestational age

Secondary Outcomes

Incidence of moderate/severe OHSS

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

Number of metaphase 2 oocytes

Time frame: within 1 day of ovum pick up

number of 2 PN embryos

Time frame: 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.

Time frame: 2-3 weeks after embryo transfer