Trial | NCT02388802  Report issue

Title

Human Clinical Trial of Uterine Transplantation in the United Kingdom
The First Human Clinical Trial of Uterine Transplantation in the United Kingdom

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Unknown status

  • Intervention/Treatment

    prednisone tacrolimus mycophenolate ...

  • Study Participants

    10
Ten patients will undergo uterine transplantation.
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 Started
Jan 31
2017
Primary Completion
Jan 31
2020
Anticipated
Study Completion
Jan 31
2020
Anticipated
Last Update
Nov 08
2016
Estimate

Procedure Oocyte retrieval and freezing

10 Patients will undergo oocyte retrieval and freezing

Procedure Deceased Donor Allograft Excision

Appropriately matched uterine transplant allografts will be excised from deceased donors

  • Other names: Cadaveric Donor Allograft Excision

Procedure Uterine Transplantation

Following egg freezing the patients will undergo uterine transplant from deceased donors

  • Other names: Womb Transplant

Drug Immunosuppressive Agents

Patients will be appropriately immunosuppressed, whilst being closely monitored clinically, radiologically and immunologically.

  • Other names: Immunosuppressives

Procedure In-vitro fertilisation

12 months after successful transplantation,the patients will undergo IVF

  • Other names: IVF

Procedure Caesarean Section

Following successful conception and antenatal period, the babies will be born by Caesarean Section

Uterine transplant Experimental

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

Criteria 

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
No Results Posted