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Human Clinical Trial of Uterine Transplantation in the United Kingdom

Primary Purpose

Infertility

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Oocyte retrieval and freezing
Deceased Donor Allograft Excision
Uterine Transplantation
Immunosuppressive Agents
In-vitro fertilisation
Caesarean Section
Sponsored by
Womb Transplant UK
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Infertility focused on measuring Infertility, Transplant, IVF, Hysterectomy, Absolute uterine infertility

Eligibility Criteria

18 Years - 36 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Uterine transplant

    Arm Description

    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

    Outcomes

    Primary Outcome Measures

    Transplant success
    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

    Pregnancy rate
    Efficacy as measured by the number of patients successful of conception by IVF
    Live birth rate
    Efficacy as measured by the number of live births following successful conception

    Full Information

    First Posted
    February 12, 2015
    Last Updated
    November 7, 2016
    Sponsor
    Womb Transplant UK
    Collaborators
    Imperial College London
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02388802
    Brief Title
    Human Clinical Trial of Uterine Transplantation in the United Kingdom
    Official Title
    The First Human Clinical Trial of Uterine Transplantation in the United Kingdom
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2016
    Overall Recruitment Status
    Unknown status
    Study Start Date
    January 2017 (undefined)
    Primary Completion Date
    January 2020 (Anticipated)
    Study Completion Date
    January 2020 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Womb Transplant UK
    Collaborators
    Imperial College London

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Infertility
    Keywords
    Infertility, Transplant, IVF, Hysterectomy, Absolute uterine infertility

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    10 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Uterine transplant
    Arm Type
    Experimental
    Arm Description
    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
    Intervention Type
    Procedure
    Intervention Name(s)
    Oocyte retrieval and freezing
    Intervention Description
    10 Patients will undergo oocyte retrieval and freezing
    Intervention Type
    Procedure
    Intervention Name(s)
    Deceased Donor Allograft Excision
    Other Intervention Name(s)
    Cadaveric Donor Allograft Excision
    Intervention Description
    Appropriately matched uterine transplant allografts will be excised from deceased donors
    Intervention Type
    Procedure
    Intervention Name(s)
    Uterine Transplantation
    Other Intervention Name(s)
    Womb Transplant
    Intervention Description
    Following egg freezing the patients will undergo uterine transplant from deceased donors
    Intervention Type
    Drug
    Intervention Name(s)
    Immunosuppressive Agents
    Other Intervention Name(s)
    Immunosuppressives
    Intervention Description
    Patients will be appropriately immunosuppressed, whilst being closely monitored clinically, radiologically and immunologically.
    Intervention Type
    Procedure
    Intervention Name(s)
    In-vitro fertilisation
    Other Intervention Name(s)
    IVF
    Intervention Description
    12 months after successful transplantation,the patients will undergo IVF
    Intervention Type
    Procedure
    Intervention Name(s)
    Caesarean Section
    Intervention Description
    Following successful conception and antenatal period, the babies will be born by Caesarean Section
    Primary Outcome Measure Information:
    Title
    Transplant success
    Description
    Efficacy as measured by successful graft transplantation with no clinical, immunological or radiological signs of graft rejection within the first 12 months post-operatively.
    Time Frame
    12 months
    Secondary Outcome Measure Information:
    Title
    Pregnancy rate
    Description
    Efficacy as measured by the number of patients successful of conception by IVF
    Time Frame
    24 months
    Title
    Live birth rate
    Description
    Efficacy as measured by the number of live births following successful conception
    Time Frame
    36 months

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    36 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Benjamin P Jones, MBChB BSc
    Phone
    +447740358900
    Email
    benjamin.jones@nhs.net
    First Name & Middle Initial & Last Name or Official Title & Degree
    Srdjan Saso, MRCS PhD BSc
    Phone
    +447890795182
    Email
    srdjan.saso01@imperial.ac.uk
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Richard Smith, FRCOG, MD
    Organizational Affiliation
    Imperial NHS Healthcare Trust
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Human Clinical Trial of Uterine Transplantation in the United Kingdom

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