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INSITU: INvestigational Study Into Transplantation of the Uterus

Sponsor
Womb Transplant UK (Other)
Overall Status
Recruiting
CT.gov ID
NCT04244409
Collaborator
Oxford University Hospitals NHS Trust (Other), Imperial College Healthcare NHS Trust (Other)
10
Enrollment
1
Location
60
Anticipated Duration (Months)
0.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Observational study on cohort of 10 women undergoing uterine transplantation using deceased donors

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    10 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    INvestigational Study Into Transplantation of the Uterus
    Actual Study Start Date :
    Feb 18, 2019
    Anticipated Primary Completion Date :
    Feb 18, 2022
    Anticipated Study Completion Date :
    Feb 18, 2024

    Outcome Measures

    Primary Outcome Measures

    1. Live birth rate [5 years]

    Secondary Outcome Measures

    1. Pregnancy rate [5 years]

    2. Transplant success rate [3 years]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    24 Years to 38 Years
    Sexes Eligible for Study:
    Female
    Inclusion Criteria:

    1. Female

    2. Age - 24-38 (or 40 if eggs frozen <38)

    3. AUFI

    4. Normal length vagina

    5. No renal pathology

    6. BMI <30kg/m2

    7. ASA grade I

    8. Meet psychological criteria

    9. Meet HFEA criteria for IVF

    10. Eligible for NHS treatment

    11. Speak fluent English

    Exclusion Criteria:

    1. Unsuccessful oocyte retrieval (<10 good quality embryos)

    2. Previous multiple/significant surgeries

    3. Severe endometriosis

    4. Cancer patients <5 years in remission

    5. Previous living childbirth, adopted child or child born through surrogacy

    6. HIV or Hepatitis B / C positive

    7. Skin or intestinal neovagina

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Hammersmith Hospital, Imperial College NHS Trust London United Kingdom W12 0HS

    Sponsors and Collaborators

    • Womb Transplant UK
    • Oxford University Hospitals NHS Trust
    • Imperial College Healthcare NHS Trust

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Ben Jones, Principal Investigator, Imperial College Healthcare NHS Trust
    ClinicalTrials.gov Identifier:
    NCT04244409
    Other Study ID Numbers:
    • WombTransplantUK
    First Posted:
    Jan 28, 2020
    Last Update Posted:
    Jan 28, 2020
    Last Verified:
    Jan 1, 2020
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Ben Jones, Principal Investigator, Imperial College Healthcare NHS Trust
    Gynaecology
    Immunosuppression
    In-vitro Fertilisation
    Infertility
    MRKH
    Pregnancy
    Transplantation
    Uterus
    Additional relevant MeSH terms:
    Postpartum Hemorrhage
    Syndrome
    Hemorrhage

    Study Results

    No Results Posted as of Jan 28, 2020