NCT05089513

Brief Summary

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

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
2

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
terminated

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

First Submitted

Initial submission to the registry

October 14, 2021

Completed
7 days until next milestone

Study Start

First participant enrolled

October 21, 2021

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 22, 2021

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2022

Completed
Last Updated

June 24, 2024

Status Verified

June 1, 2024

Enrollment Period

10 months

First QC Date

October 14, 2021

Last Update Submit

June 21, 2024

Conditions

Absolute Uterine Factor Infertility

Keywords

uterus, infertility, transplantation, robotics

Outcome Measures

Primary Outcomes (1)

  • Surgical success

    Uterus with viability and regular menstruations

    0-4 months

Secondary Outcomes (1)

  • Pregnancy rate

    10-48 months

Other Outcomes (1)

  • Live birth rate per attempted and surgically succesful transplantation

    19-72 months

Study Arms (1)

Robotic surgery

EXPERIMENTAL

Robotic surgery in both live donor and recipient

Procedure: Robotic surgery

Interventions

Robotic surgeryPROCEDURE

Robotoc surgery (Da Vinci) in both donor and recipient

Robotic surgery

Eligibility Criteria

Age18 Years - 38 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • Smoking, systemic disease, psychological instability

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Sahlgrenska

Gothenburg, None Selected, 41345, Sweden

Location

Sahlgrenska University Hospital

Gothenburg, 41345, Sweden

Location

MeSH Terms

Conditions

Infertility

Interventions

Robotic Surgical Procedures

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Intervention Hierarchy (Ancestors)

Surgery, Computer-AssistedSurgical Procedures, OperativeRoboticsAutomationTechnologyTechnology, Industry, and Agriculture

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

October 14, 2021

First Posted

October 22, 2021

Study Start

October 21, 2021

Primary Completion

August 30, 2022

Study Completion

August 30, 2022

Last Updated

June 24, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will not share

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

Locations

SE(2)