Difference Between Progestin Primed Ovarian Stimulation Protocol and Antagonist Protocol

NCT ID: NCT06738602

Last Updated: 2024-12-17

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 270 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-12-30
• Study Completion Date: 2027-12-30

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.

Conditions

Infertility Assisted Reproductive Technology

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Progestin Primed Ovarian Stimulation Protocol group

No interventions assigned to this group

Antagonist Protocol group

No interventions assigned to this group

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Khaled Mostafa Ahmed

Comparison between progestin primed ovarian stimulation protocol and antagonist protocol in hyper-responder patients schaduled for freeze all policy

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Khaled Mostafa Principal Investigator, M.Sc

Role: CONTACT

khaledmostafa8200893@gmail.com

01004770872

Other Identifiers

Induction protocols in IVF

Identifier Type: -

Identifier Source: org_study_id