INvestigational Study Into Transplantation of the Uterus (INSITU)

January 23, 2020 updated by: Ben Jones, Womb Transplant UK
Observational study on cohort of 10 women undergoing uterine transplantation using deceased donors

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Anticipated)

10

Contacts and Locations

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

Study Locations

  • United Kingdom
      • London, United Kingdom, W12 0HS
        • Recruiting
        • Hammersmith Hospital, Imperial College NHS Trust
        • Contact:

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

24 years to 38 years (Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Women with absolute uterine factor infertility

Description

Inclusion Criteria:

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

  3. AUFI

    1. Normal length vagina
    2. No renal pathology
  4. BMI <30kg/m2
  5. ASA grade I
  6. Meet psychological criteria
  7. Meet HFEA criteria for IVF
  8. Eligible for NHS treatment
  9. 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

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Live birth rate
Time Frame: 5 years
5 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Pregnancy rate
Time Frame: 5 years
5 years
Transplant success rate
Time Frame: 3 years
3 years

Collaborators and Investigators

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

Sponsor

Womb Transplant UK

Collaborators

Oxford University Hospitals NHS Trust
Imperial College Healthcare NHS 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 (Actual)

February 18, 2019

Primary Completion (Anticipated)

February 18, 2022

Study Completion (Anticipated)

February 18, 2024

Study Registration Dates

First Submitted

January 23, 2020

First Submitted That Met QC Criteria

January 23, 2020

First Posted (Actual)

January 28, 2020

Study Record Updates

Last Update Posted (Actual)

January 28, 2020

Last Update Submitted That Met QC Criteria

January 23, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • WombTransplantUK

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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