Feasibility Study of Uterine Transplantation from Living Donors in Terms of Efficacy and Safety in Patients with Mayer-Rokitansky-Küster-Hauser Syndrome (MRKH)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Hopital Foch
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Pregnancy
研究概览
简要总结
In France, one in 4500 women is affected by the MayerRokitantskyKüsterHauser (MRKH) syndrome which is characterized by the absence of uterus at birth. Currently, the only solutions for these patients are:
- Gestational surrogacy, prohibited in France
- Adoption
- Resignation
Uterine transplantation could become a good alternative.
This study is conducted in 10 patients with MRKH type I syndrome, who will be transplanted from a living donor uterus
详细描述
The aim of the study is to obtain a pregnancy after uterine transplantation from a living donor. Also, this study will assess (anatomically and functionally) the issue of the transplants of a uterus taken from a living donor and the safety of the living donor (functionally and psychologically)
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
- 是
入选标准
- •Graft recipient is a patient with Mayer-Rokitansky-Küster-Hauser Type I Uterine Vaginal Agenesis (without renal, cardiac and bone malformations):
- •Being aged between 18 and 38 years old
- •In stable couple, with a pregnancy project, favorable psychological evaluation
- •No history of cancer and transfusion
- •The living donor is a woman related to the Graft recipient with
- •Absence of comorbidity (neurological, nephro-urological pathology, infectious, psychiatric or psychological pathology)
- •Absence of uterine surgery, abdomino-pelvic major pathology history
排除标准
- •Graft recipient:
- •Extreme oligo-astheno-spermia and azoospermia in the husband
- •History of abdominopelvic surgery excluding uncomplicated appendectomy; vaginal residue not allowing anastomosis
- •Living donor :
- •Known thromboembolic risk factor
- •No Compatibility with the recipient (group, rhesus, HLA)
结局指标
主要结局
Pregnancy
时间窗: 3 years
Obtaining of a pregnancy after uterine transplantation from a living donor
次要结局
- Psychological assessment of the donor and the recipient(7 years)
- Graft Rejection assessment(5 years)
- Safety assessment of the donor, the recipient and the fœtus(7 years)