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Uterus Transplantation by Robotics - Gothenburg III (Robot2)

Primary Purpose

Absolute Uterine Factor Infertility

Status
Recruiting
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Robotic surgery
Sponsored by
Sahlgrenska University Hospital, Sweden
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Absolute Uterine Factor Infertility focused on measuring uterus, infertility, transplantation, robotics

Eligibility Criteria

18 Years - 38 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

Smoking, systemic disease, psychological instability

Sites / Locations

  • SahlgrenskaRecruiting
  • Sahlgrenska University HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Robotic surgery

Arm Description

Robotic surgery in both live donor and recipient

Outcomes

Primary Outcome Measures

Surgical success
Uterus with viability and regular menstruations

Secondary Outcome Measures

Pregnancy rate
Pregnancy rate per ET

Full Information

First Posted
October 14, 2021
Last Updated
December 14, 2021
Sponsor
Sahlgrenska University Hospital, Sweden
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1. Study Identification

Unique Protocol Identification Number
NCT05089513
Brief Title
Uterus Transplantation by Robotics - Gothenburg III
Acronym
Robot2
Official Title
Uterus Transplantation by Robotics and in Donor and Recipient
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Recruiting
Study Start Date
October 21, 2021 (Actual)
Primary Completion Date
August 30, 2022 (Anticipated)
Study Completion Date
August 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sahlgrenska University Hospital, Sweden

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Absolute Uterine Factor Infertility
Keywords
uterus, infertility, transplantation, robotics

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
5 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Robotic surgery
Arm Type
Experimental
Arm Description
Robotic surgery in both live donor and recipient
Intervention Type
Procedure
Intervention Name(s)
Robotic surgery
Intervention Description
Robotoc surgery (Da Vinci) in both donor and recipient
Primary Outcome Measure Information:
Title
Surgical success
Description
Uterus with viability and regular menstruations
Time Frame
0-4 months
Secondary Outcome Measure Information:
Title
Pregnancy rate
Description
Pregnancy rate per ET
Time Frame
10-48 months
Other Pre-specified Outcome Measures:
Title
Live birth rate per attempted and surgically succesful transplantation
Description
Live birth rates
Time Frame
19-72 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
38 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Uterine factor infertility, age 18-38 years, psychological stable, in steady relationship. Exclusion Criteria: Smoking, systemic disease, psychological instability
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mats Brännström, MD, PhD
Phone
+46736254455
Email
mats.brannstrom@obgyn.gu.se
First Name & Middle Initial & Last Name or Official Title & Degree
Pernilla Dahm-Kahler, MD, PhD
Phone
+46707632847
Email
pernilla.dahm-kahler@vgregion.se
Facility Information:
Facility Name
Sahlgrenska
City
Göteborg
State/Province
None Selected
ZIP/Postal Code
41345
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mats Brännström
Phone
0736254455
Email
mats.brannstrom@obgyn.gu.se
Facility Name
Sahlgrenska University Hospital
City
Gothenburg
ZIP/Postal Code
41345
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mats Brännström, MD

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Only group dat will be published and shared after publication, in order to avoid identification of a person

Learn more about this trial

Uterus Transplantation by Robotics - Gothenburg III

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