The First Human Clinical Trial of Uterine Transplantation in the United Kingdom
试验速览
- 阶段
- 不适用
- 入组人数
- 10
- 主要终点
- Transplant success
研究概览
简要总结
Ten patients will undergo uterine transplantation.
详细描述
Ten patients that will be appropriately selected using a variety of physical and psychological assessments. The selected patients will undergo egg retrieval and subsequent freezing of embryos to enable IVF treatment following transplantation. Following uterine transplantation, using deceased donor allografts, the patients will be closely monitored for 12 months clinically, radiologically and immunologically until embryo transfer. Following successful embryo transfer the patients will continue to be monitored antenatally until they are delivered by Caesarean section.
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
- 否
入选标准
- •Between 18-36 years of age
- •Absolute Uterine factor infertility
排除标准
- •Poor ovarian reserve - Unsuccessful oocyte retrieval
- •No intercurrent significant medical or psychiatric co-morbidities
- •Previous oncology patients <5 years in remission
- •Outside of age range
- •Normal BMI
研究组 & 干预措施
Uterine transplant
10 patients will be appropriately selected to undergo oocyte retrieval and freezing. Subsequently deceased donor allograft excision will take place prior to uterine transplantation. Immunosuppressive agents will be used to optimise graft success until successful In-vitro fertilisation and subsequent delivery by Caesarean Section
干预措施: Oocyte retrieval and freezing (Procedure)
Uterine transplant
10 patients will be appropriately selected to undergo oocyte retrieval and freezing. Subsequently deceased donor allograft excision will take place prior to uterine transplantation. Immunosuppressive agents will be used to optimise graft success until successful In-vitro fertilisation and subsequent delivery by Caesarean Section
干预措施: Deceased Donor Allograft Excision (Procedure)
Uterine transplant
10 patients will be appropriately selected to undergo oocyte retrieval and freezing. Subsequently deceased donor allograft excision will take place prior to uterine transplantation. Immunosuppressive agents will be used to optimise graft success until successful In-vitro fertilisation and subsequent delivery by Caesarean Section
干预措施: Uterine Transplantation (Procedure)
Uterine transplant
10 patients will be appropriately selected to undergo oocyte retrieval and freezing. Subsequently deceased donor allograft excision will take place prior to uterine transplantation. Immunosuppressive agents will be used to optimise graft success until successful In-vitro fertilisation and subsequent delivery by Caesarean Section
干预措施: Immunosuppressive Agents (Drug)
Uterine transplant
10 patients will be appropriately selected to undergo oocyte retrieval and freezing. Subsequently deceased donor allograft excision will take place prior to uterine transplantation. Immunosuppressive agents will be used to optimise graft success until successful In-vitro fertilisation and subsequent delivery by Caesarean Section
干预措施: In-vitro fertilisation (Procedure)
Uterine transplant
10 patients will be appropriately selected to undergo oocyte retrieval and freezing. Subsequently deceased donor allograft excision will take place prior to uterine transplantation. Immunosuppressive agents will be used to optimise graft success until successful In-vitro fertilisation and subsequent delivery by Caesarean Section
干预措施: Caesarean Section (Procedure)
结局指标
主要结局
Transplant success
时间窗: 12 months
Efficacy as measured by successful graft transplantation with no clinical, immunological or radiological signs of graft rejection within the first 12 months post-operatively.
次要结局
- Pregnancy rate(24 months)
- Live birth rate(36 months)