Uterus Transplantation From Live Donors With Robotic Assisted Surgery - Gothenburg II (UTX-robot)
June 21, 2024 updated by: Mats Brännström, Sahlgrenska University Hospital, Sweden
The study is a follow up of NCT01844362.
Uterus transplantation will be performed from live donors to patients with uterine factor infertility.
If will be performed before transplantation.
Organ procurement from the donor will be performed by robotic assisted laparoscopy.
Transplantation will be by laparotomy.
Embryo transfer will be done 10-12 months after transplantation.
After birth of 1-3 children the uterus will be removed by hysterectomy,
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The study is a follow up of NCT01844362.
Uterus transplantation will be performed from live donors to patients with uterine factor infertility.
If will be performed before transplantation.
Organ procurement from the donor will be performed by robotic assisted laparoscopy.
Transplantation will be by laparotomy.
Embryo transfer will be done 10-12 months after transplantation.
After birth of 1-3 children the uterus will be removed by hysterectomy.
Study Type
Observational
Enrollment (Actual)
8
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
-
-
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Gothenburg, Sweden, 41345
- Sahlgrenska University Hospital
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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
20 years to 38 years (Adult)
Accepts Healthy Volunteers
Yes
Sampling Method
Non-Probability Sample
Study Population
absolute uterine factor infertile women > 38 years
Description
Inclusion Criteria:
- age below 38 years
- absolute uterine factor infertility
- BMI<30
Exclusion Criteria:
- systemic disease
- psychiatric disease
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
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Live births after uterus transplantation
Time Frame: 5 years
|
Assessed by records from birthing unit and Swedish National Birth registry
|
5 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Development of children after uterus transplantation
Time Frame: 8 years
|
Assessed by growth parameters and neuropsychiatric tests (Bayley Mental Scale, M-CHAT, CBCL, WPPSI-IV)
|
8 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Mats Brännström, MD, PhD, Göteborg University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Dahm-Kahler P, Kvarnstrom N, Brannstrom M. Robotic live donor hysterectomy. Curr Opin Organ Transplant. 2021 Dec 1;26(6):640-645. doi: 10.1097/MOT.0000000000000926.
- Brannstrom M, Kvarnstrom N, Groth K, Akouri R, Wiman L, Enskog A, Dahm-Kahler P. Evolution of surgical steps in robotics-assisted donor surgery for uterus transplantation: results of the eight cases in the Swedish trial. Fertil Steril. 2020 Nov;114(5):1097-1107. doi: 10.1016/j.fertnstert.2020.05.027. Epub 2020 Aug 19.
- Brannstrom M, Dahm-Kahler P, Ekberg J, Akouri R, Groth K, Enskog A, Broecker V, Molne J, Ayoubi JM, Kvarnstrom N. Outcome of Recipient Surgery and 6-Month Follow-Up of the Swedish Live Donor Robotic Uterus Transplantation Trial. J Clin Med. 2020 Jul 22;9(8):2338. doi: 10.3390/jcm9082338.
- Brannstrom M, Dahm-Kahler P, Kvarnstrom N, Enskog A, Olofsson JI, Olausson M, Molne J, Akouri R, Jarvholm S, Nilsson L, Stigson L, Hagberg H, Bokstrom H. Reproductive, obstetric, and long-term health outcome after uterus transplantation: results of the first clinical trial. Fertil Steril. 2022 Sep;118(3):576-585. doi: 10.1016/j.fertnstert.2022.05.017. Epub 2022 Jun 11.
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
November 1, 2016
Primary Completion (Actual)
December 1, 2021
Study Completion (Actual)
December 1, 2021
Study Registration Dates
First Submitted
November 29, 2016
First Submitted That Met QC Criteria
December 5, 2016
First Posted (Estimated)
December 8, 2016
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
- SahlgrenskaUTx
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
Individual data will not be shared.
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.