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临床试验/NCT06950476
NCT06950476已完成不适用

Assisted Reproductive Technology Cycle Outcomes When Only 1 to 3 Oocytes Are Retrieved: a Retrospective Analysis of 3,671 Cycles in Poor Responders From a Large Volume Single Center

Istituto Clinico Humanitas0 个研究点目标入组 3,761 人开始时间: 2010年1月1日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
3,761
主要终点
Clinical Pregnancy Rate (CPR)

研究概览

简要总结

This is a monocentric retrospective observational study. The study focuses on the women who underwent Assisted Reproductive Technology (ART) cycles with poor ovarian response (POR), defined as <4 oocytes retrieved.

The objectives of the study are as follows:

  • Evaluate clinical pregnancy rate (CPR) and cumulative live birth rate (CLBR) in women with poor ovarian response.
  • Evaluate abortion rate in women with poor ovarian response.
  • Evaluate the influence of patient characteristics (age, Anti-Müllerian hormone [AMH] levels, Antral Follicle Count [AFC], Follicle Stimulating Hormone [FSH], Body Mass Index [BMI]) on women with poor ovarian response.

To address the study objectives, data will be collected using a specific internal web-based database. All oocyte retrieval procedures performed at the Humanitas Fertility Center from January 2010 to December 2023 will be included in the evaluation. Outcomes will be expressed in terms of CLBR, CPR and Abortion Rate.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Retrospective

入排标准

性别
All
接受健康志愿者

入选标准

  • The study database will include all women who underwent IVF treatment between 2010 and 2023 and were classified as poor ovarian responders, defined as those who retrieved fewer than 4 oocytes following controlled ovarian stimulation.

排除标准

  • The study database will exclude women who underwent IVF treatment and retrieved more than 3 oocytes following controlled ovarian stimulation.

结局指标

主要结局

Clinical Pregnancy Rate (CPR)

时间窗: January 2010 - December 2023

This study aims to evaluate the ART outcomes in women classified as poor ovarian responders (POR), focusing on clinical pregnancy rate. The CPR is defined as the number of clinical pregnancies expressed per 100 initiated cycles.

Cumulative Live Birth Rate (CLBR)

时间窗: January 2010 - December 2023

This study aims to evaluate the ART outcomes in women classified as poor ovarian responders (POR), focusing on cumulative live birth rates The CLBR is defined as the likelihood of achieving at least one live birth over a series of treatment cycles, including both fresh and frozen embryo transfers, originating from a single ovarian stimulation.

Abortion Rate

时间窗: January 2010 - December 2023

This study aims to evaluate the ART outcomes in women classified as poor ovarian responders (POR), focusing on abortion rates. Abortion rate is defined as the presence of an empty gestational sac or a gestational sac containing an embryo or fetus without fetal cardiac activity, occurring within the first 12 6/7 weeks of gestation.

次要结局

未报告次要终点

研究者

发起方
Istituto Clinico Humanitas
申办方类型
Other
责任方
Sponsor

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