NCT04244409

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Feb 2019

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 18, 2019

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

January 23, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 28, 2020

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 18, 2022

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 18, 2024

Completed
Last Updated

January 28, 2020

Status Verified

January 1, 2020

Enrollment Period

3 years

First QC Date

January 23, 2020

Last Update Submit

January 23, 2020

Conditions

Mayer-Rokitansky-Kuster SyndromeAsherson's SyndromePostpartum HemorrhageCervical Cancer

Keywords

GynaecologyImmunosuppressionIn-vitro FertilisationInfertilityMRKHPregnancyTransplantationUterus

Outcome Measures

Primary Outcomes (1)

  • Live birth rate

    5 years

Secondary Outcomes (2)

  • Pregnancy rate

    5 years

  • Transplant success rate

    3 years

Eligibility Criteria

Age24 Years - 38 Years
Sexfemale
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Women with absolute uterine factor infertility

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hammersmith Hospital, Imperial College NHS Trust

London, W12 0HS, United Kingdom

RECRUITING

MeSH Terms

Conditions

Mullerian aplasiaPostpartum HemorrhageUterine Cervical NeoplasmsInfertility

Condition Hierarchy (Ancestors)

Obstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesPuerperal DisordersUterine HemorrhageHemorrhagePathologic ProcessesPathological Conditions, Signs and SymptomsUterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesGenital Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 23, 2020

First Posted

January 28, 2020

Study Start

February 18, 2019

Primary Completion

February 18, 2022

Study Completion

February 18, 2024

Last Updated

January 28, 2020

Record last verified: 2020-01

Locations

GB(1)