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NCT04244409 Clinical Trial

INvestigational Study Into Transplantation of the Uterus

Cervical Cancer Clinical Trial

— INSITU  

Official title:
INvestigational Study Into Transplantation of the Uterus

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04244409
Other study ID # WombTransplantUK
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date February 18, 2019
Est. completion date February 18, 2024

Study information
Verified date January 2020
Source Womb Transplant UK
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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

Recruitment information / eligibility
Status Recruiting
Enrollment 10
Est. completion date February 18, 2024
Est. primary completion date February 18, 2022
Accepts healthy volunteers
Gender Female
Age group 24 Years to 38 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Locations
Country Name City State
United Kingdom Hammersmith Hospital, Imperial College NHS Trust London

Sponsors (3)
Lead Sponsor Collaborator
Womb Transplant UK Imperial College Healthcare NHS Trust, Oxford University Hospitals NHS Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary Live birth rate 5 years
Secondary Pregnancy rate 5 years
Secondary Transplant success rate 3 years
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