Clinical trial NCT06738602: Difference Between Progestin Primed Ovarian Stimulation Protocol and Antagonist Protocol
Official title: Comparison Between Progestin Primed Ovarian Stimulation Protocol and Antagonist Protocol in Hyper-responder Patients Schaduled for Freeze All Policy
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Infertility Assisted Reproductive Technology
Keywords: progestin primed ovarian stimulation
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2024-12-17
Enrollment: 270
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: * Eligible patients will be identified and recruited from the IVF Unit at Women's Health Hospital.
* Informed consent will be obtained from all participants prior to inclusion in the study.

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.

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

Primary outcomes:
measure: • 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
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
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