Uterus Transplantation From Live Donor (utx)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
The Swedish Research Council
Information provided by (Responsible Party):
Mats Brännström, Sahlgrenska University Hospital, Sweden
ClinicalTrials.gov Identifier:
NCT01844362
First received: April 23, 2013
Last updated: July 1, 2013
Last verified: July 2013
  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
Evidence of Uterine Transplantation
Primary Uterine Infertility
Procedure: uterine transplantation

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 Sahlgrenska University Hospital, Sweden:

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

Secondary Outcome Measures:
  • pregnancy rate [ Time Frame: up to 3 years after transplantation ] [ Designated as safety issue: Yes ]

Other Outcome Measures:
  • live birth rate [ Time Frame: up to 4 years after transplantation ] [ Designated as safety issue: No ]

Estimated Enrollment: 10
Study Start Date: September 2012
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: June 2014 (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.
Other Name: uterine transplantation

  Eligibility

Ages Eligible for Study:   18 Years to 39 Years
Genders 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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided by Sahlgrenska University Hospital, Sweden

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Mats Brännström, Professor, Sahlgrenska University Hospital, Sweden
ClinicalTrials.gov Identifier: NCT01844362     History of Changes
Other Study ID Numbers: utx-ld
Study First Received: April 23, 2013
Last Updated: July 1, 2013
Health Authority: Sweden: Security committee of EPN Göteborg

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

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

ClinicalTrials.gov processed this record on August 21, 2014