Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Uterus Transplantation From Live Donors and From Deceased Donors - Clinical Study (UTxLD/DBD)

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03277430
Recruitment Status : Recruiting
First Posted : September 11, 2017
Last Update Posted : February 27, 2019
Sponsor:
Collaborators:
University Hospital, Motol
Sahlgrenska University Hospital, Sweden
Information provided by (Responsible Party):
Jiri Fronek, Institute for Clinical and Experimental Medicine

Brief Summary:
Uterus transplantation (UTx) is the only causative treatment for congenital or acquired uterus absence. Individual cases of UTx from a live donor (LD UTx) with healthy child birth performed so far showed favourable outcomes. The present study will include both LD UTx and UTx from deceased donors after brain death (DBD UTx). The aim is treatment of uterine infertility by UTx. It is is an ethically justifiable life-promoting transplantation. Twenty UTx will be performed in 2 parallel arms: 10 LD UTx and 10 DBD UTx. Immunosuppression will be administered. Phases of the UTx procedure are: in vitro fertilization - cryopreservation of embryos - uterus retrieval - UTx - follow up - embryo transfer - pregnancy - child birth - later graft hysterectomy - life long follow up. Introduction of UTx into clinical practice may enable women with uterine infertility to have their own children.

Condition or disease Intervention/treatment Phase
Mayer Rokitansky Kuster Hauser Syndrome Mullerian Aplasia Uterus; Absence, Congenital Infertility, Female Uterus Absence, Acquired Absolute Uterine Factor Infertility Procedure: Live donor uterus transplantation Procedure: Deceased donor uterus transplantation Drug: Tacrolimus Phase 3

  Show Detailed Description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Uterus Transplantation From Live Donors and From Deceased Donors - Clinical Study
Actual Study Start Date : October 9, 2015
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2025


Arm Intervention/treatment
Experimental: Live donor uterus transplantation
Transplantation of uterus from a living donor. Immunosuppression with tacrolimus.
Procedure: Live donor uterus transplantation
Transplantation of uterus from a living donor.

Drug: Tacrolimus
Maintenance immunosuppression in UTx recipient will be reduced to tacrolimus monotherapy to minimalize fetal compromise.
Other Name: FK506

Experimental: Deceased donor uterus transplantation
Transplantation of uterus from a deceased brain-dead donor. Immunosuppression with tacrolimus.
Procedure: Deceased donor uterus transplantation
Transplantation of uterus from a deceased brain-dead donor.

Drug: Tacrolimus
Maintenance immunosuppression in UTx recipient will be reduced to tacrolimus monotherapy to minimalize fetal compromise.
Other Name: FK506




Primary Outcome Measures :
  1. Efficacy of uterus transplantation. [ Time Frame: Until 10 live donor and 10 deceased donor uterus transplants have been performed plus approximately 5 years. ]
    Number of successful uterus transplantations and healthy child births. Treatment of absolute uterine factor infertility that has no other therapy option by uterus transplantation that includes in vitro fertilization and cryopreservation, uterus transplantation from a live donor or from a deceased donor, graft survival on immunosuppression, embryo transfer, pregnancy and child birth, final graft hysterectomy.


Secondary Outcome Measures :
  1. Comparison of efficacy of uterus transplantation from live donors versus deceased donors. [ Time Frame: Until 10 live donor and 10 deceased donor uterus transplants have been performed plus approximately 5 years. ]
    Number of successful uterus transplantations and healthy child births from live donors versus deceased donors.

  2. Rate of adverse events after uterus transplantation [ Time Frame: Until 10 live donor and 10 deceased donor uterus transplants have been performed plus approximately 5 years. ]
    Number of recipients of uterus transplantation with adverse events.

  3. Rate of adverse events after live uterus donation [ Time Frame: Until 10 live donor transplants have been performed plus approximately 5 years. ]
    Number of live donor participants after uterus retrieval with adverse events.

  4. Rate of adverse events during pregnancy and child birth after uterus transplantation [ Time Frame: Until 10 live donor and 10 deceased donor uterus transplants have been performed plus approximately 5 years. ]
    Number of children conceived and born from transplanted uterus with adverse events.

  5. Verification of technique of uterus retrieval [ Time Frame: Until 10 live donor and 10 deceased donor uterus transplants have been performed plus approximately 5 years. ]
    Verification of surgical technique of uterus retrieval from a live donor and from a deceased donor.



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.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria for UTx recipient:

  • 18 - 40 years of age
  • good general health
  • congenital or acquired uterus absence
  • desire for a child

Exclusion Criteria for UTx recipient:

  • age over 40
  • serious comorbidity

Inclusion Criteria for a live uterus donor:

  • female
  • 18 - 60 years of age
  • maximum 4 child births
  • maximum 1 Cesarian section
  • good general health

Exclusion Criteria for a live uterus donor:

  • age over 60
  • hypertension with organ damage
  • diabetes mellitus
  • other serious comorbidity

Inclusion Criteria for a deceased brain-dead uterus donor:

  • female
  • age under 60
  • no previous hysterectomy
  • no previous uterus malignancy

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): NCT03277430


Contacts
Layout table for location contacts
Contact: Jiri Fronek, Assoc Prof +420 26 136 4105 jifr@ikem.cz
Contact: Renata Zamecnikova, Bc +420 26 136 4105, 5300 zamr@ikem.cz

Locations
Layout table for location information
Czechia
Institute for Clinical and Experimental Medicine Recruiting
Prague, Czechia, 14021
Contact: Jiri Fronek, Assoc Prof    +420 26 136 4105    jifr@ikem.cz   
Contact: Renata Zamecnikova, Bc    +420 26 136 4105    zamr@ikem.cz   
Principal Investigator: Jiri Fronek, Assoc Prof         
Sub-Investigator: Roman Chmel, MD PhD         
Sub-Investigator: Michael Olausson, Prof         
Sponsors and Collaborators
Institute for Clinical and Experimental Medicine
University Hospital, Motol
Sahlgrenska University Hospital, Sweden
Investigators
Layout table for investigator information
Principal Investigator: Jiri Fronek, Assoc Prof Transplant Surgery Department, Institute of Clinical and Experimental Medicine, Prague, Czech Republic

Additional Information:
Publications:

Layout table for additonal information
Responsible Party: Jiri Fronek, MD PhD Assoc Prof, Institute for Clinical and Experimental Medicine
ClinicalTrials.gov Identifier: NCT03277430     History of Changes
Other Study ID Numbers: 2044/15 (NM-15-01)
First Posted: September 11, 2017    Key Record Dates
Last Update Posted: February 27, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jiri Fronek, Institute for Clinical and Experimental Medicine:
uterus transplantation, absolute uterine factor infertility
Additional relevant MeSH terms:
Layout table for MeSH terms
Infertility
Infertility, Female
Genital Diseases, Male
Genital Diseases, Female
Tacrolimus
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Calcineurin Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action