INvestigational Study Into Transplantation of the Uterus

• Conditions: Mayer-Rokitansky-Kuster Syndrome; Asherson's Syndrome; Cervical Cancer; Postpartum Hemorrhage

• Registration Number: NCT04244409
• Lead Sponsor: Womb Transplant UK

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2019-02-18
• Status Verified: 2020-01
• Study First Submitted: 2020-01-23
• Study First Submitted QC: 2020-01-23
• Last Update Submitted: 2020-01-23
• Study First Posted: 2020-01-28
• Last Update Posted: 2020-01-28
• Primary Completion: 2022-02-18
• Study Completion: 2024-02-18

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 10

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Live birth rate	5 years

Secondary Outcome Measures

Name	Time	Method
Pregnancy rate	5 years
Transplant success rate	3 years

Trial Locations

Locations (1)

Hammersmith Hospital, Imperial College NHS Trust; 🇬🇧 London, United Kingdom