Difference Between Progestin Primed Ovarian Stimulation Protocol and Antagonist Protocol

Not yet recruiting

• Conditions: Infertility Assisted Reproductive Technology

• Registration Number: NCT06738602
• Lead Sponsor: Assiut University

Brief Summary

compare the effectiveness and safety of the progestin primed ovarian stimulation (PPOS) protocol versus the antagonist protocol in hyper-responder patients scheduled for a freeze-all policy

Detailed Description

Infertility treatments have evolved significantly over the past few decades, with various protocols being developed to optimize ovarian stimulation in assisted reproductive technology (ART). Among these protocols, the progestin-primed ovarian stimulation (PPOS) and the antagonist protocols have gained prominence, especially in hyper-responders who are scheduled for a freeze-all policy. Hyper-responders are patients who produce an excessive number of eggs in response to ovarian stimulation, which increases the risk of ovarian hyperstimulation syndrome (OHSS), a potentially severe complication .

The PPOS protocol involves the administration of progestins to suppress the premature luteinizing hormone (LH) surge during ovarian stimulation, thereby providing a controlled environment for follicle development. This method has been found to be effective in reducing the risk of OHSS and improving clinical outcomes . On the other hand, the antagonist protocol employs gonadotropin-releasing hormone (GnRH) antagonists to prevent the LH surge, offering a more immediate suppression compared to progestins .

A freeze-all policy, where all viable embryos are frozen for future use rather than being transferred immediately, is often recommended for hyper-responders to further minimize the risk of OHSS . This approach allows for the transfer of embryos in a more physiologically normal uterine environment, potentially improving implantation rates and pregnancy outcomes .

This study aims to compare the effectiveness and safety of the PPOS protocol versus the antagonist protocol in hyper-responder patients scheduled for a freeze-all policy. By examining outcomes such as the number of retrieved oocytes, incidence of OHSS, and pregnancy rates, this research seeks to provide insights into the optimal ovarian stimulation strategy for this specific patient population.

Study Timeline

• Status Verified: 2024-12
• Study First Submitted: 2024-12-10
• Study First Submitted QC: 2024-12-13
• Last Update Submitted: 2024-12-13
• Study First Posted: 2024-12-17
• Last Update Posted: 2024-12-17
• Study Start: 2024-12-30
• Primary Completion: 2026-12-30
• Study Completion: 2027-12-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 270

Inclusion Criteria

• All hyper responder patients according to Olivera equation for overian response peridiction index

Exclusion Criteria

• All normal and poor responder patients according to Olivera equation for overian response peridiction index.
• Sever male factor infertility

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
• Clinical pregnancy rate: The presence of a gestational sac with fetal heartbeat on ultrasound at 7 weeks of gestation. • Live birth rate: The delivery of a live-born infant beyond 24 weeks of gestation	1 year	the measure unit is the presence of pulsation in 7-week gestational sac or delivery if fetus beyond 24 weeks as if fetus below 24 w gestation , it's considered abortion