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临床试验/NCT03284073
NCT03284073Unknown不适用

First Clinical Live-Donor Uterus Transplantation Trial In Egypt

Amro M. Hetta, M.Sc.2 个研究点 分布在 1 个国家目标入组 11 人开始时间: 2021年9月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
11
试验地点
2
主要终点
Surviving transplants (8-12 months)

研究概览

简要总结

More than a decade ago, uterus transplantation (UTx) as a highly experimental procedure was the treatment which had been developed for women suffering from absolute uterine factor infertility (AUFI) [uterus absence (congenital and surgical), or an abnormality (anatomic and functional)].

In Egypt, People's religions, current ethical and legal backgrounds make the option of live-donor uterus transplantation appealing rather than alternative pathways to parenthood. Thus, its clinical application for the first time in Egypt should be initiated after an extensive review and analysis of literature for UTx technology development in the world, and for further possible contributions to future prospects by Egypt proposed UTx project team which will participate in our study.

详细描述

More than a decade ago, uterus transplantation (UTx) as a highly experimental procedure was the treatment which had been developed for women suffering from absolute uterine factor infertility (AUFI) [uterus absence (congenital and surgical), or an abnormality (anatomic and functional)].

In Egypt, People's religions, current ethical and legal backgrounds make the option of live-donor uterus transplantation appealing rather than alternative pathways to parenthood. Thus, its clinical application for the first time in Egypt should be initiated after an extensive review and analysis of literature for UTx technology development in the world, and for further possible contributions to future prospects by Egypt proposed UTx project team which will participate in our study.

The study protocol includes live-donor UTx (mother, relative, friend) into women with AUFI. The recipient will be treated by standard immunosuppression and transfer of embryos (acquired by IVF before surgery) will be attempted after 8-12 months have passed from transplantation. Two official approvals must be obtained before starting recruitment process; from both (Higher Committee of Human Organ Transplantation of Egyptian Ministry of Health and Population, and Al-Azhar University Council).

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 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Less than 45 years old
  • Good general health

排除标准

  • Older than 45 years old
  • Poor ovarian reserve
  • Systematic or psychiatric disease

结局指标

主要结局

Surviving transplants (8-12 months)

时间窗: Up to 3 years after transplantation

Follow up

次要结局

  • Spontaneous menstruation commencement(Up to 3 months after transplantation)
  • Pregnancy rate(Up to 3 years after transplantation)
  • Live birth rate(Up to 4 years after transplantation)

研究者

发起方
Amro M. Hetta, M.Sc.
申办方类型
Other Gov
责任方
Sponsor Investigator
主要研究者

Amro M. Hetta, M.Sc.

Principal Investigator

Talkha Central Hospital

研究点 (2)

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