Uterus Transplantation From Live Donors and From Deceased Donors - Clinical Study
UTxLD/DBD
1 other identifier
interventional
20
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Oct 2015
Longer than P75 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 9, 2015
CompletedFirst Submitted
Initial submission to the registry
September 4, 2017
CompletedFirst Posted
Study publicly available on registry
September 11, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2025
CompletedFebruary 27, 2019
February 1, 2019
5.2 years
September 4, 2017
February 25, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Efficacy of uterus transplantation.
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.
Until 10 live donor and 10 deceased donor uterus transplants have been performed plus approximately 5 years.
Secondary Outcomes (5)
Comparison of efficacy of uterus transplantation from live donors versus deceased donors.
Until 10 live donor and 10 deceased donor uterus transplants have been performed plus approximately 5 years.
Rate of adverse events after uterus transplantation
Until 10 live donor and 10 deceased donor uterus transplants have been performed plus approximately 5 years.
Rate of adverse events after live uterus donation
Until 10 live donor transplants have been performed plus approximately 5 years.
Rate of adverse events during pregnancy and child birth after uterus transplantation
Until 10 live donor and 10 deceased donor uterus transplants have been performed plus approximately 5 years.
Verification of technique of uterus retrieval
Until 10 live donor and 10 deceased donor uterus transplants have been performed plus approximately 5 years.
Study Arms (2)
Live donor uterus transplantation
EXPERIMENTALTransplantation of uterus from a living donor. Immunosuppression with tacrolimus.
Deceased donor uterus transplantation
EXPERIMENTALTransplantation of uterus from a deceased brain-dead donor. Immunosuppression with tacrolimus.
Interventions
Transplantation of uterus from a living donor.
Transplantation of uterus from a deceased brain-dead donor.
Maintenance immunosuppression in UTx recipient will be reduced to tacrolimus monotherapy to minimalize fetal compromise.
Eligibility Criteria
You may qualify if:
- years of age
- good general health
- congenital or acquired uterus absence
- desire for a child
You may not qualify if:
- age over 40
- serious comorbidity
- female
- years of age
- maximum 4 child births
- maximum 1 Cesarian section
- good general health
- age over 60
- hypertension with organ damage
- diabetes mellitus
- other serious comorbidity
- female
- age under 60
- no previous hysterectomy
- no previous uterus malignancy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Institute for Clinical and Experimental Medicinelead
- University Hospital, Motolcollaborator
- Sahlgrenska University Hospitalcollaborator
Study Sites (1)
Institute for Clinical and Experimental Medicine
Prague, 14021, Czechia
Related Publications (8)
Erman Akar M, Ozekinci M, Alper O, Demir D, Cevikol C, Meric Bilekdemir A, Daloglu A, Ongut G, Senol Y, Ozdem S, Uzun G, Luleci G, Suleymanlar G. Assessment of women who applied for the uterine transplant project as potential candidates for uterus transplantation. J Obstet Gynaecol Res. 2015 Jan;41(1):12-6. doi: 10.1111/jog.12486. Epub 2014 Sep 17.
PMID: 25226847BACKGROUNDOlausson M, Johannesson L, Brattgard D, Diaz-Garcia C, Lundmark C, Groth K, Marcickiewizc J, Enskog A, Akouri R, Tzakis A, Rogiers X, Janson PO, Brannstrom M. Ethics of uterus transplantation with live donors. Fertil Steril. 2014 Jul;102(1):40-3. doi: 10.1016/j.fertnstert.2014.03.048. Epub 2014 Apr 28. No abstract available.
PMID: 24784936BACKGROUNDJohannesson L, Dahm-Kahler P, Eklind S, Brannstrom M. The future of human uterus transplantation. Womens Health (Lond). 2014 Jul;10(4):455-67. doi: 10.2217/whe.14.22.
PMID: 25259905BACKGROUNDFarrell RM, Falcone T. Uterine transplantation. Fertil Steril. 2014 May;101(5):1244-5. doi: 10.1016/j.fertnstert.2014.03.022. Epub 2014 Apr 13. No abstract available.
PMID: 24726215BACKGROUNDBrannstrom 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.
PMID: 24582522BACKGROUNDOzturk H. How real is the uterine transplantation? Ann Transplant. 2014 Feb 14;19:82-3. doi: 10.12659/AOT.889973. No abstract available.
PMID: 24535028BACKGROUNDAkar ME, Ozkan O, Ozekinci M, Sindel M, Yildirim F, Oguz N. Uterus retrieval in cadaver: technical aspects. Clin Exp Obstet Gynecol. 2014;41(3):293-5.
PMID: 24992779BACKGROUNDFronek J, Janousek L, Kristek J, Chlupac J, Pluta M, Novotny R, Maluskova J, Olausson M. Live Birth Following Uterine Transplantation From a Nulliparous Deceased Donor. Transplantation. 2021 May 1;105(5):1077-1081. doi: 10.1097/TP.0000000000003346.
PMID: 32541565DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jiri Fronek, Assoc Prof
Transplant Surgery Department, Institute of Clinical and Experimental Medicine, Prague, Czech Republic
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD PhD Assoc Prof
Study Record Dates
First Submitted
September 4, 2017
First Posted
September 11, 2017
Study Start
October 9, 2015
Primary Completion
December 31, 2020
Study Completion
December 31, 2025
Last Updated
February 27, 2019
Record last verified: 2019-02