跳至主要内容
临床试验/NCT04314869
NCT04314869招募中不适用

Feasibility Study of Uterus Transplantation Procedure From a Live Donor Obtaining the Graft by Laparoscopy

Hospital Clinic of Barcelona2 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2020年5月23日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
10
试验地点
2
主要终点
Number of grafts obtained by laparoscopy

研究概览

简要总结

Absolut uterine factor, meaning the absence of uterus, represents a cause for sterility without the possibility of a present treatment. The uterine factor affects millions of women and may be due to congenital problems, such as the Muller anomalies (Mayer Rockitansky Syndrome) or acquired by previous hysterectomy or intrauterine adhesions (Asherman's Syndrome). The uterine transplant would represent the only possibility for patients with an absolute uterine factor to achieve both genetic and gestational maternity.

详细描述

To obtain by laparoscopy a viable uterus for transplantation from a living donor is feasible. The laparoscopic procedure increases safety and provides the benefits of minimally invasive surgery to the grafting technique already described by laparotomy. The objective of the present study is to develop a pilot program in the transplant of a living donor. We include 5 pairs of uterine donor-transplant recipients indicated for sterility by absolute uterine factor due to Mayer Rokitansky Syndrome. Patients will undergo surgery for this transplant and after 6 months of it with correct function of the graft, embryos will be transferred in order to achieve pregnancy. C-section will be performed for delivery. The attempt of two gestations (if there are sufficient cryopreserved embryos for a second gestation) and withdrawing the graft (hysterectomy) and, therefore, immunosuppression is agreed.

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 65 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Number of grafts obtained by laparoscopy

时间窗: 2 years

It is feasible to obtain the graft by laparoscopy

次要结局

  • Number of healthy newborns(5 years)

研究者

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

Francisco Carmona

Head of Gynecology Department

Hospital Clinic of Barcelona

研究点 (2)

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