INvestigational Study Into Transplantation of the Uterus | NCT04244409

Studies
INvestigational Study Into Transplantation of the Uterus

NCT04244409

Sponsor

Womb Transplant UK

Status

Unknown status

Last Update Posted

Jan 28, 2020Actual

Enrollment

10Estimated

Phase

Not provided

Conditions

Mayer-Rokitansky-Kuster Syndrome
Asherson's Syndrome
Postpartum Hemorrhage
Cervical Cancer

Interventions

Not provided

Countries

United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 18, 2019Actual

Primary Completion Date

Feb 18, 2022Estimated

Completion Date

Feb 18, 2024Estimated

First Submitted Date

Jan 23, 2020

First Submission Date that Met QC Criteria

Jan 23, 2020

First Posted Date

Jan 28, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 23, 2020

Last Update Posted Date

Jan 28, 2020Actual

Name	Class
Oxford University Hospitals NHS Trust	OTHER
Imperial College Healthcare NHS Trust	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

10Estimated

Measure	Description	Time Frame
Live birth rate		5 years

Measure	Description	Time Frame
Pregnancy rate		5 years
Transplant success rate		3 years

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Accepts Healthy Volunteers

Not provided

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

24 Years

Maximum Age

38 Years

Standard Ages

Adult

Study Population

Women with absolute uterine factor infertility

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hammersmith Hospital, Imperial College NHS Trust	Recruiting	London		W12 0HS	United Kingdom

Condition Browse Module

MeSH Terms

ID	Term
C537371	Mullerian aplasia
D006473	Postpartum Hemorrhage
D002583	Uterine Cervical Neoplasms
D007246	Infertility

Ancestor Terms

ID	Term
D007744	Obstetric Labor Complications
D011248	Pregnancy Complications
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided