Uterus Transplantation by Robotics - Gothenburg III (Robot2)

June 21, 2024 updated by: Mats Brännström, Sahlgrenska University Hospital, Sweden

Uterus Transplantation by Robotics and in Donor and Recipient

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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

2

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Gothenburg, Sweden, 41345
        • Sahlgrenska University Hospital
    • None Selected
      • Göteborg, None Selected, Sweden, 41345
        • Sahlgrenska

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 38 years (Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Exclusion Criteria:

Smoking, systemic disease, psychological instability

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Robotic surgery
Robotic surgery in both live donor and recipient
Procedure: Robotic surgery
Robotoc surgery (Da Vinci) in both donor and recipient

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Other Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sahlgrenska University Hospital, Sweden

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 21, 2021

Primary Completion (Actual)

August 30, 2022

Study Completion (Actual)

August 30, 2022

Study Registration Dates

First Submitted

October 14, 2021

First Submitted That Met QC Criteria

October 14, 2021

First Posted (Actual)

October 22, 2021

Study Record Updates

Last Update Posted (Actual)

June 24, 2024

Last Update Submitted That Met QC Criteria

June 21, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Robot 2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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