NCT03252795招募中不适用
Uterus Transplantation From a Multi-organ Donor: A Prospective Trial
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Survival of the uterus 1 year after transplantation
研究概览
简要总结
Uterus transplantation: screening, in vitro fertilization [IVF] treatment to be able to freeze embryos, uterus transplantation, pregnancy and afterwards removal of the uterus.
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 38 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female with Maier-Rokitansky-Kuster-Hauser syndrome
- •Mucosal neovagina of at least 7 cm
- •In a stable relationship for at least 1 year
- •Child wish
- •Good renal function (and presence of both kidneys)
- •Psychologically stable and compliant
- •At least 8 frozen embryos after IVF/intracytoplasmic sperm injection [ICSI]
- •Living in Belgium and a good health insurance
- •Willing and able to provide informed consent
排除标准
- •Major pelvic surgery
- •Major chronic illnesses
- •Other risk factors or malignancies
- •BMI > 30
结局指标
主要结局
Survival of the uterus 1 year after transplantation
时间窗: 1 year after uterus transplantation
Survival of the uterus 1 year after transplantation
Ongoing pregnancy rate
时间窗: 4 weeks after embryo transfer
Ongoing pregnancy rate
Complications after uterus transplantation
时间窗: As long as the uterus remains in situ (the uterus will be removed within one year after delivery)
Complications after uterus transplantation
Take home baby rate
时间窗: 9 months after embryo transfer
Take home baby rate
次要结局
未报告次要终点
研究者
研究点 (2)
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