Uterus Transplantation LD - Feasibility Study - Sahlgrens... | NCT03590405

Studies
Uterus Transplantation LD - Feasibility Study - Sahlgrenska - BMC

NCT03590405

Sponsor

Sahlgrenska University Hospital

Status

Completed

Last Update Posted

Dec 15, 2021Actual

Enrollment

2Actual

Phase

Not Applicable

Conditions

Mrk Anomaly
Infertility, Female

Interventions

uterus transplantation surgery and IVF

Countries

Sweden

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

Dec 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 15, 2018Actual

Primary Completion Date

Dec 1, 2021Actual

Completion Date

Dec 1, 2021Actual

First Submitted Date

Jun 17, 2018

First Submission Date that Met QC Criteria

Jul 6, 2018

First Posted Date

Jul 18, 2018Actual

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

Dec 14, 2021

Last Update Posted Date

Dec 15, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Mats Brännström, Professor, Sahlgrenska University HospitalPrincipal Investigator

Lead Sponsor

Sahlgrenska University HospitalOTHER

Collaborators

Name	Class
Saint Joseph University, at Bellevue Medical Centre	UNKNOWN

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

Description Module

Brief Summary

Medical know-how concerning uterus transplantation will be transferred to new site by structured process involving theory, animal workshops and a clinical feasibility study on human subjects.

Detailed Description

Medical know-how concerning uterus transplantation will be transferred to new site by structured process involving theory, animal workshops and surgery.

Theory and common animal workshops have been ongoing for 3 years. The team from Bellevue Medical Centre is affiliated to St Joseph, University, Beirut

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

2Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
uterus transplantation	Experimental	uterus transplantation from living donor with the donor being close relative	Procedure: uterus transplantation surgery and IVF

Interventions

Name	Type	Description	Arm Group Labels	Other Names
uterus transplantation surgery and IVF	Procedure	IVF before surgery living donor uterus transplantation ET	uterus transplantation

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
live birth	live birth	3 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion criteria recipient

age < 38 years
psychologicaly stable
BMI < 35
no systemic disease
no standing medication
in a stable relationship or married
normal ovarian reserve
absolute uterine factor infertility
normal kidney function

Inclusion criteria donor

close relative to recipient
age < 60 years
normal pregnancies
maximum two cesarean sections
BMI < 35
no major systemic disease
no previous major surgery

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

Only females

Minimum Age

18 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Mats Brännström, MD, PhD	Sahlgrenska University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Sahlgrenska University Hospital		Gothenburg		41345	Sweden
Mats Brännström

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
C537371	Mullerian aplasia
D007247	Infertility, Female
D007246	Infertility

Ancestor Terms

ID	Term
D005831	Genital Diseases, Female
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided