- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04244409
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
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
-
-
-
London, United Kingdom, W12 0HS
- Recruiting
- Hammersmith Hospital, Imperial College NHS Trust
-
Contact:
- Benjamin Jones, MRCOG
- Phone Number: 02033131000
- Email: benjamin.jones@nhs.net
-
-
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:
- Female
- Age - 24-38 (or 40 if eggs frozen <38)
AUFI
- Normal length vagina
- No renal pathology
- BMI <30kg/m2
- ASA grade I
- Meet psychological criteria
- Meet HFEA criteria for IVF
- Eligible for NHS treatment
- Speak fluent English
Exclusion Criteria:
- Unsuccessful oocyte retrieval (<10 good quality embryos)
- Previous multiple/significant surgeries
- Severe endometriosis
- Cancer patients <5 years in remission
- Previous living childbirth, adopted child or child born through surrogacy
- HIV or Hepatitis B / C positive
- 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
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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