跳至主要内容
临床试验/NCT06738602
NCT06738602尚未招募不适用

Comparison Between Progestin Primed Ovarian Stimulation Protocol and Antagonist Protocol in Hyper-responder Patients Schaduled for Freeze All Policy

Assiut University0 个研究点目标入组 270 人开始时间: 2024年12月30日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
270
主要终点
• 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

研究概览

简要总结

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

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
20 Years 至 40 Years(Adult)
性别
Female
接受健康志愿者

入选标准

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

排除标准

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

结局指标

主要结局

• 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

时间窗: 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

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Khaled Mostafa Ahmed

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

Assiut University

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