Human Clinical Trial of Uterine Transplantation in the United Kingdom

Not Applicable

• Conditions: Infertility
• Interventions: Procedure: Oocyte retrieval and freezing; Procedure: Deceased Donor Allograft Excision; Procedure: Uterine Transplantation; Drug: Immunosuppressive Agents; Procedure: In-vitro fertilisation; Procedure: Caesarean Section

• Registration Number: NCT02388802
• Lead Sponsor: Womb Transplant UK

Brief Summary

Ten patients will undergo uterine transplantation.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2015-02-12
• Study First Submitted QC: 2015-03-09
• Study First Posted: 2015-03-17
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-07
• Last Update Posted: 2016-11-08
• Study Start: 2017-01
• Primary Completion: 2020-01
• Study Completion: 2020-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 10

Inclusion Criteria

• Female
• Between 18-36 years of age
• Absolute Uterine factor infertility

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Uterine transplant	Deceased Donor Allograft Excision	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
Uterine transplant	Uterine Transplantation	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
Uterine transplant	Immunosuppressive Agents	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
Uterine transplant	In-vitro fertilisation	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
Uterine transplant	Oocyte retrieval and freezing	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
Uterine transplant	Caesarean Section	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

Primary Outcome Measures

Name	Time	Method
Transplant success	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.

Secondary Outcome Measures

Name	Time	Method
Pregnancy rate	24 months	Efficacy as measured by the number of patients successful of conception by IVF
Live birth rate	36 months	Efficacy as measured by the number of live births following successful conception