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Uterus Transplantation LD - Feasibility Study - Sahlgrenska - BMC (GOT-BMC-UTx)

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ClinicalTrials.gov Identifier: NCT03590405
Recruitment Status : Recruiting
First Posted : July 18, 2018
Last Update Posted : July 23, 2018
Sponsor:
Collaborator:
Saint Joseph University, at Bellevue Medical Centre
Information provided by (Responsible Party):
Mats Brännström, Sahlgrenska University Hospital, Sweden

Brief Summary:
Medical know-how concerning uterus transplantation will be transferred to new site by structured process involving theory, animal workshops and a clinical feasibility study on human subjects.

Condition or disease Intervention/treatment Phase
Mrk Anomaly Infertility, Female Procedure: uterus transplantation surgery and IVF Not Applicable

Detailed Description:

Medical know-how concerning uterus transplantation will be transferred to new site by structured process involving theory, animal workshops and surgery.

Theory and common animal workshops have been ongoing for 3 years. The team from Bellevue Medical Centre is affiliated to St Joseph, University, Beirut


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 5 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Uterus Transplantation LD - Feasibility Study - Sahlgrenska - Bellevue Medical Centre
Actual Study Start Date : June 15, 2018
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: uterus transplantation
uterus transplantation from living donor with the donor being close relative
Procedure: uterus transplantation surgery and IVF
IVF before surgery living donor uterus transplantation ET




Primary Outcome Measures :
  1. live birth [ Time Frame: 3 years ]
    live birth



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Only females
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion criteria recipient

  • age < 38 years
  • psychologicaly stable
  • BMI < 35
  • no systemic disease
  • no standing medication
  • in a stable relationship or married
  • normal ovarian reserve
  • absolute uterine factor infertility
  • normal kidney function

Inclusion criteria donor

  • close relative to recipient
  • age < 60 years
  • normal pregnancies
  • maximum two cesarean sections
  • BMI < 35
  • no major systemic disease
  • no previous major surgery

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): NCT03590405


Contacts
Contact: Mats Brännström, MD, PhD +46736254455 mats.brannstrom@obgyn.gu.se
Contact: Anna-Karin Tholin anna-karin.tholin@vgregion.se

Locations
Sweden
Sahlgrenska University Hospital Recruiting
Gothenburg, Sweden, 41345
Contact: Mats Brännström, MD         
Mats Brännström Recruiting
Göteborg, Sweden, SE-41345
Contact: Mats Brännström, MD, PhD    +46736254455    mats.brannstrom@obgyn.gu.se   
Principal Investigator: Mats Brännström, MD, PhD         
Sponsors and Collaborators
Sahlgrenska University Hospital, Sweden
Saint Joseph University, at Bellevue Medical Centre
Investigators
Principal Investigator: Mats Brännström, MD, PhD Sahlgrenska University Hospital, Sweden

Responsible Party: Mats Brännström, Professor, Sahlgrenska University Hospital, Sweden
ClinicalTrials.gov Identifier: NCT03590405     History of Changes
Other Study ID Numbers: Sahlgrenska-BMC-UTx
First Posted: July 18, 2018    Key Record Dates
Last Update Posted: July 23, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

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

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