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Uterus Transplantation From Live Donor (utx)

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01844362
First Posted: May 1, 2013
Last Update Posted: November 30, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
The Swedish Research Council
Information provided by (Responsible Party):
Mats Brännström, Sahlgrenska University Hospital, Sweden
  Purpose

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.


Condition Intervention
Primary Uterine Infertility Procedure: uterine transplantation

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prospective Case Series of Human Uterus Transplantation From Live Donor

Resource links provided by NLM:


Further study details as provided by Mats Brännström, Sahlgrenska University Hospital, Sweden:

Primary Outcome Measures:
  • surviving transplants (12 months) [ Time Frame: up to 3 years after transplantation ]

Secondary Outcome Measures:
  • pregnancy rate [ Time Frame: up to 3 years after transplantation ]

Other Outcome Measures:
  • live birth rate [ Time Frame: up to 4 years after transplantation ]

Estimated Enrollment: 10
Study Start Date: September 2012
Estimated Study Completion Date: April 2018
Estimated Primary Completion Date: April 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Uterine transplantation
Patients undergo transplantation of the uterus from live donor.
Procedure: uterine transplantation
Transplantation of the uterus from live donor and IVF treatment.

Detailed Description:
The study is ongoing, with inclusion of 9 patients.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 39 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • less than 39 years
  • good general health

Exclusion Criteria:

  • poor ovarian resaerve or older than 39 years
  • systemic or psychiatric disease
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01844362


Locations
Sweden
Mats Brännström
Göteborg, Sweden, SE-41345
Sponsors and Collaborators
Sahlgrenska University Hospital, Sweden
The Swedish Research Council
Investigators
Principal Investigator: Mats Brännström, MD, PhD Göteborg University
  More Information

Publications:

Responsible Party: Mats Brännström, Professor, Sahlgrenska University Hospital, Sweden
ClinicalTrials.gov Identifier: NCT01844362     History of Changes
Other Study ID Numbers: utx-ld
First Submitted: April 23, 2013
First Posted: May 1, 2013
Last Update Posted: November 30, 2016
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Scientific publications

Keywords provided by Mats Brännström, Sahlgrenska University Hospital, Sweden:
uterus
transplantation
infertility

Additional relevant MeSH terms:
Infertility
Genital Diseases, Male
Genital Diseases, Female