Uterus Transplantation by Robotics - Gothenburg III | NCT05089513

Studies
Uterus Transplantation by Robotics - Gothenburg III

NCT05089513

Sponsor

Sahlgrenska University Hospital

Status

Terminated

Last Update Posted

Jun 24, 2024Actual

Enrollment

2Actual

Phase

Not Applicable

Conditions

Absolute Uterine Factor Infertility

Interventions

Robotic surgery

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

Jun 2024

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

slow recruitment

Expanded Access Info

Start Date

Oct 21, 2021Actual

Primary Completion Date

Aug 30, 2022Actual

Completion Date

Aug 30, 2022Actual

First Submitted Date

Oct 14, 2021

First Submission Date that Met QC Criteria

Oct 14, 2021

First Posted Date

Oct 22, 2021Actual

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

Jun 21, 2024

Last Update Posted Date

Jun 24, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

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

Robotic assisted organ procurement and robotic assisted transplantation in live donor uterus transplantation

Detailed Description

Inclusion; absolute uterine factor infertility, age between 18 and 38, BMI less than 28, non-smoker

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
Robotic surgery	Experimental	Robotic surgery in both live donor and recipient	Procedure: Robotic surgery

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Robotic surgery	Procedure	Robotoc surgery (Da Vinci) in both donor and recipient	Robotic surgery

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Surgical success	Uterus with viability and regular menstruations	0-4 months

Secondary Outcomes

Measure	Description	Time Frame
Pregnancy rate	Pregnancy rate per ET	10-48 months

Other Outcomes

Measure	Description	Time Frame
Live birth rate per attempted and surgically succesful transplantation	Live birth rates	19-72 months

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Uterine factor infertility, age 18-38 years, psychological stable, in steady relationship.

Exclusion Criteria:

Smoking, systemic disease, psychological instability

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

38 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Sahlgrenska		Gothenburg	None Selected	41345	Sweden
Sahlgrenska University Hospital

IPD Sharing Statement Module

Plan to Share IPD

Description

Only group dat will be published and shared after publication, in order to avoid identification of a person

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D007246	Infertility

Ancestor Terms

ID	Term
D000091662	Genital Diseases
D000091642	Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D065287	Robotic Surgical Procedures

Ancestor Terms

ID	Term
D025321	Surgery, Computer-Assisted
D013514	Surgical Procedures, Operative
D012371	Robotics
D001331	Automation

Browse Leaves

Not provided

Browse Branches

Not provided