Human Clinical Trial of Uterine Transplantation in the United Kingdom

November 7, 2016 updated by: Womb Transplant UK

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

Ten patients will undergo uterine transplantation.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 36 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Transplant success
Time Frame: 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.
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pregnancy rate
Time Frame: 24 months
Efficacy as measured by the number of patients successful of conception by IVF
24 months
Live birth rate
Time Frame: 36 months
Efficacy as measured by the number of live births following successful conception
36 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Womb Transplant UK

Collaborators

Imperial College London

Investigators

  • Principal Investigator: Richard Smith, FRCOG, MD, Imperial NHS Healthcare Trust

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2017

Primary Completion (Anticipated)

January 1, 2020

Study Completion (Anticipated)

January 1, 2020

Study Registration Dates

First Submitted

February 12, 2015

First Submitted That Met QC Criteria

March 9, 2015

First Posted (Estimate)

March 17, 2015

Study Record Updates

Last Update Posted (Estimate)

November 8, 2016

Last Update Submitted That Met QC Criteria

November 7, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1 (Other Identifier: Mobile Health and Wellness Program)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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