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临床试验/NCT04131244
NCT04131244已完成不适用

In Vitro Follicle Activation of Dormant Follicles in Patient With Premature Ovarian Failure Under 36 Years Old

Hacettepe University2 个研究点 分布在 2 个国家目标入组 10 人开始时间: 2017年12月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
10
试验地点
2
主要终点
Live birth

研究概览

简要总结

This is a clinical trial that the investigators aim to validate In-vitro Activation (IVA) treatment protocol, which was previously defined by Kazuhiro Kawamura (MD) and Aaron Hsueh (PhD), in Turkish patient with Premature Ovarian Insufficiency (POI) under age 36.

详细描述

The objectives of the study is as following;

  • Validation of the previously defined In-Vitro Activation Protocol approach in Turkish patients under 36 years old with Premature Ovarian Insufficiency (POI).
  • Giving an opportunity to young POI patient in Turkey for having genetically own baby.
  • Primary outcome measure would be live birth.
  • For activation of primordial follicles, phosphatase and tensin homolog (PTEN) inhibitor and protein kinase B (AKT) stimulator will be used.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 36 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Patient with POI
  • Short amenorrhea period (1 - 2 years)

排除标准

  • Having been treated with chemotherapy and/or radiotherapy;
  • Having been diagnosed with advanced stage of endometriosis (endometriomas)
  • Having been diagnosed with the chronic diseases such as diabetes, cardiac failure, kidney insufficiency, morbid obesity etc..
  • Presence of chromosomal abnormality (Turner, Fragile-X etc.)
  • Previous multiple laparotomies
  • Menopause >10 years
  • Accompanied azoospermia

结局指标

主要结局

Live birth

时间窗: 2 years

The primary outcome is live birth, defined as the delivery of a live-born infant at 24 weeks of gestation

次要结局

  • Follicle growth rate(1 year)
  • M-II oocyte rate(1 year)
  • Day 2-3 good quality embryo rate(1 year)
  • Clinical pregnancy rate(2 years)

研究者

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

Sezcan Mumusoglu

Assistant Professor

Hacettepe University

研究点 (2)

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