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Uterus Transplantation From Live Donor (utx)

Primary Purpose

Primary Uterine Infertility

Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
uterine transplantation
Sponsored by
Sahlgrenska University Hospital, Sweden
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

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

Eligibility Criteria

18 Years - 39 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • less than 39 years
  • good general health

Exclusion Criteria:

  • poor ovarian resaerve or older than 39 years
  • systemic or psychiatric disease

Sites / Locations

  • Mats Brännström

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Uterine transplantation

Arm Description

Patients undergo transplantation of the uterus from live donor.

Outcomes

Primary Outcome Measures

surviving transplants (12 months)

Secondary Outcome Measures

pregnancy rate

Full Information

First Posted
April 23, 2013
Last Updated
December 14, 2021
Sponsor
Sahlgrenska University Hospital, Sweden
Collaborators
The Swedish Research Council
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1. Study Identification

Unique Protocol Identification Number
NCT01844362
Brief Title
Uterus Transplantation From Live Donor
Acronym
utx
Official Title
Prospective Case Series of Human Uterus Transplantation From Live Donor
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
September 2012 (Actual)
Primary Completion Date
April 2018 (Actual)
Study Completion Date
December 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sahlgrenska University Hospital, Sweden
Collaborators
The Swedish Research Council

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Uterus transplantation, as a possible future treatment for uterine factor infertility, has been developed in animal species during the last decade. The study protocol includes transplantation of the uterus from a live donor (mother, relative, friend) into women with absolute uterine factor infertility (lack of uterus from birth or due to life saving hysterectomy).The recipient will be treated by standard immunosuppression and transfer of embryos (acquired by IVF before surgery) will be attempted when at least 12 months have passed from transplantation. Approval for a case series including up to 10 patients has been acquired.
Detailed Description
The study is ongoing, with inclusion of 9 patients.

6. Conditions and Keywords

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

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Uterine transplantation
Arm Type
Experimental
Arm Description
Patients undergo transplantation of the uterus from live donor.
Intervention Type
Procedure
Intervention Name(s)
uterine transplantation
Intervention Description
Transplantation of the uterus from live donor and IVF treatment.
Primary Outcome Measure Information:
Title
surviving transplants (12 months)
Time Frame
up to 3 years after transplantation
Secondary Outcome Measure Information:
Title
pregnancy rate
Time Frame
up to 3 years after transplantation
Other Pre-specified Outcome Measures:
Title
live birth rate
Time Frame
up to 4 years after transplantation

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
39 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: less than 39 years good general health Exclusion Criteria: poor ovarian resaerve or older than 39 years systemic or psychiatric disease
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mats Brännström, MD, PhD
Organizational Affiliation
Göteborg University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mats Brännström
City
Göteborg
ZIP/Postal Code
SE-41345
Country
Sweden

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Scientific publications
Citations:
PubMed Identifier
27125227
Citation
Brannstrom M, Bokstrom H, Dahm-Kahler P, Diaz-Garcia C, Ekberg J, Enskog A, Hagberg H, Johannesson L, Kvarnstrom N, Molne J, Olausson M, Olofsson JI, Rodriguez-Wallberg K. One uterus bridging three generations: first live birth after mother-to-daughter uterus transplantation. Fertil Steril. 2016 Aug;106(2):261-6. doi: 10.1016/j.fertnstert.2016.04.001. Epub 2016 Apr 25.
Results Reference
result
PubMed Identifier
25439846
Citation
Johannesson L, Kvarnstrom N, Molne J, Dahm-Kahler P, Enskog A, Diaz-Garcia C, Olausson M, Brannstrom M. Uterus transplantation trial: 1-year outcome. Fertil Steril. 2015 Jan;103(1):199-204. doi: 10.1016/j.fertnstert.2014.09.024. Epub 2014 Oct 22.
Results Reference
result
PubMed Identifier
25301505
Citation
Brannstrom M, Johannesson L, Bokstrom H, Kvarnstrom N, Molne J, Dahm-Kahler P, Enskog A, Milenkovic M, Ekberg J, Diaz-Garcia C, Gabel M, Hanafy A, Hagberg H, Olausson M, Nilsson L. Livebirth after uterus transplantation. Lancet. 2015 Feb 14;385(9968):607-616. doi: 10.1016/S0140-6736(14)61728-1. Epub 2014 Oct 6.
Results Reference
result
PubMed Identifier
24582522
Citation
Brannstrom M, Johannesson L, Dahm-Kahler P, Enskog A, Molne J, Kvarnstrom N, Diaz-Garcia C, Hanafy A, Lundmark C, Marcickiewicz J, Gabel M, Groth K, Akouri R, Eklind S, Holgersson J, Tzakis A, Olausson M. First clinical uterus transplantation trial: a six-month report. Fertil Steril. 2014 May;101(5):1228-36. doi: 10.1016/j.fertnstert.2014.02.024. Epub 2014 Feb 27.
Results Reference
result
PubMed Identifier
26231464
Citation
Jarvholm S, Johannesson L, Clarke A, Brannstrom M. Uterus transplantation trial: Psychological evaluation of recipients and partners during the post-transplantation year. Fertil Steril. 2015 Oct;104(4):1010-1015. doi: 10.1016/j.fertnstert.2015.06.038. Epub 2015 Jul 28.
Results Reference
result
PubMed Identifier
26073658
Citation
Jarvholm S, Johannesson L, Brannstrom M. Psychological aspects in pre-transplantation assessments of patients prior to entering the first uterus transplantation trial. Acta Obstet Gynecol Scand. 2015 Oct;94(10):1035-8. doi: 10.1111/aogs.12696. Epub 2015 Jun 30.
Results Reference
result
PubMed Identifier
34865019
Citation
Jarvholm S, Bokstrom H, Enskog A, Hammarling C, Dahm-Kahler P, Brannstrom M. Striving for motherhood after uterus transplantation: a qualitative study concerning pregnancy attempts, and the first years of parenthood after transplantation. Hum Reprod. 2022 Jan 28;37(2):274-283. doi: 10.1093/humrep/deab260.
Results Reference
derived
PubMed Identifier
33247912
Citation
Davidson T, Ekberg J, Sandman L, Brannstrom M. The costs of human uterus transplantation: a study based on the nine cases of the initial Swedish live donor trial. Hum Reprod. 2021 Jan 25;36(2):358-366. doi: 10.1093/humrep/deaa301.
Results Reference
derived
PubMed Identifier
32709381
Citation
Jarvholm S, Dahm-Kahler P, Kvarnstrom N, Brannstrom M. Psychosocial outcomes of uterine transplant recipients and partners up to 3 years after transplantation: results from the Swedish trial. Fertil Steril. 2020 Aug;114(2):407-415. doi: 10.1016/j.fertnstert.2020.03.043. Epub 2020 Jul 22.
Results Reference
derived
PubMed Identifier
32619006
Citation
Jarvholm S, Enskog A, Hammarling C, Dahm-Kahler P, Brannstrom M. Uterus transplantation: joys and frustrations of becoming a 'complete' woman-a qualitative study regarding self-image in the 5-year period after transplantation. Hum Reprod. 2020 Aug 1;35(8):1855-1863. doi: 10.1093/humrep/deaa143.
Results Reference
derived
PubMed Identifier
31241745
Citation
Jarvholm S, Kvarnstrom N, Dahm-Kahler P, Brannstrom M. Donors' health-related quality-of-life and psychosocial outcomes 3 years after uterus donation for transplantation. Hum Reprod. 2019 Jul 8;34(7):1270-1277. doi: 10.1093/humrep/dez087.
Results Reference
derived

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Uterus Transplantation From Live Donor

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