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Human Clinical Trial of Uterine Transplantation in the United Kingdom

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ClinicalTrials.gov Identifier: NCT02388802
Recruitment Status : Not yet recruiting
First Posted : March 17, 2015
Last Update Posted : November 8, 2016
Sponsor:
Collaborator:
Imperial College London
Information provided by (Responsible Party):
Womb Transplant UK

Brief Summary:
Ten patients will undergo uterine transplantation.

Condition or disease Intervention/treatment Phase
Infertility Procedure: Oocyte retrieval and freezing Procedure: Deceased Donor Allograft Excision Procedure: Uterine Transplantation Drug: Immunosuppressive Agents Procedure: In-vitro fertilisation Procedure: Caesarean Section Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The First Human Clinical Trial of Uterine Transplantation in the United Kingdom
Study Start Date : January 2017
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : January 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Infertility

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 Name: Cadaveric Donor Allograft Excision

Procedure: Uterine Transplantation
Following egg freezing the patients will undergo uterine transplant from deceased donors
Other Name: Womb Transplant

Drug: Immunosuppressive Agents
Patients will be appropriately immunosuppressed, whilst being closely monitored clinically, radiologically and immunologically.
Other Name: Immunosuppressives

Procedure: In-vitro fertilisation
12 months after successful transplantation,the patients will undergo IVF
Other Name: IVF

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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Pregnancy rate [ Time Frame: 24 months ]
    Efficacy as measured by the number of patients successful of conception by IVF

  2. Live birth rate [ Time Frame: 36 months ]
    Efficacy as measured by the number of live births following successful conception



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Ages Eligible for Study:   18 Years to 36 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02388802


Contacts
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Contact: Benjamin P Jones, MBChB BSc +447740358900 benjamin.jones@nhs.net
Contact: Srdjan Saso, MRCS PhD BSc +447890795182 srdjan.saso01@imperial.ac.uk

Sponsors and Collaborators
Womb Transplant UK
Imperial College London
Investigators
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Principal Investigator: Richard Smith, FRCOG, MD Imperial NHS Healthcare Trust

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Responsible Party: Womb Transplant UK
ClinicalTrials.gov Identifier: NCT02388802     History of Changes
Other Study ID Numbers: 1
First Posted: March 17, 2015    Key Record Dates
Last Update Posted: November 8, 2016
Last Verified: November 2016

Keywords provided by Womb Transplant UK:
Infertility
Transplant
IVF
Hysterectomy
Absolute uterine infertility

Additional relevant MeSH terms:
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Infertility
Genital Diseases, Male
Genital Diseases, Female
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs