Uterus Transplantation From Live Donors and From Deceased Donors - Clinical Study
NCT ID: NCT03277430
Last Updated: 2019-02-27
Study Results
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Basic Information
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RECRUITING
PHASE3
20 participants
INTERVENTIONAL
2015-10-09
2025-12-31
Brief Summary
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Detailed Description
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Aim: Treatment of absolute uterine factor infertility that has no other therapy option by uterus transplantation. Extending basic knowledge on UTx. Possible introduction of UTx into clinical practice.
Indications: UTx can be offered to patients with congenital uterus absence - aplasia uteri et vaginae, also called Mullerian aplasia or Rokitansky-Mayer-Kuster-Hauser syndrome (RMKH), in whom previous neo-vagina was created. UTx can be performed also in women with acquired uterus absence on the basis of previous hysterectomy e.g. for myomas, endometriosis, post-partum bleeding, cervical cancer, uterus malformations or intrauterine adhesions. Ovarian function must be preserved and stable male partner is required for in vitro fertilization (IVF).
Ethics: Uterus retrieval from a deceased brain-dead donor does not endanger retrieval of other life-saving organs. Live donor does not loose a vitally important organ. The only alternative is adoption of a child. Surrogacy is illegal in many european countries. UTx is the only causative treatment of AUFI. It is is an ethically justifiable life-promoting transplantation. UTx improves quality of live of both the recipient and the live donor by giving an opportunity to have an own child. Board certification for this study was obtained from the Ministry of Health of the Czech Republic and from the local Ethics Committee.
Methods: Twenty UTx will be performed in total in 2 parallel arms: 10 UTx from a live donor (LD UTx) and 10 UTx from a deceased brain-dead donor (DBD UTx). Patients who have no suitable live donor will be wait-listed for a deceased donor. Compatible blood group and negative cross-match test is required. AB0 incompatible or pair exchange transplantations are also possible. Donors and recipients will be examined by clinical, laboratory and imaging methods. All diagnostic and therapeutic procedures will be performed according to a protocol. Risk and benefit will be assessed by a multi-disciplinary team. Informed consent will be signed. Time period between UTx and embryo transfer is supposed to be about 1 year depending on condition of the recipient and the graft, e.g. level of immunosuppression, rejection or infection episodes. Adverse events will be monitored and addressed. Number of possible pregnancies and child births is estimated to be up to 2. The uterus graft will be removed in the end. Overall time interval of keeping the uterus graft in situ and exposure to immunosuppressive therapy is estimated to be up to 5 years.
Immunosuppression: Induction immunosuppression is based on thymoglobuline and corticosteroids. Maintenance immunosuppression is based on tacrolimus, mycophenolate and corticosteroids. Temporary anti-infective prophylaxis will be administered. Minimalization of immunosuppression is needed before pregnancy (monotherapy with tacrolimus). Protocol cervix biopsies to look for possible rejection will be performed. Immunosuppression will be discontinued after graft hysterectomy.
Phases of the UTx procedure: in vitro fertilization (IVF phase I) - cryopreservation of embryos - uterus retrieval from a live donor or from a deceased donor - orthotopic uterus transplantation with open technique - follow up period - embryo transfer (IVF phase II) - pregnancy - child birth via Cesarian section - later graft hysterectomy - life long follow up.
Merit: Individual cases of uterus transplantation performed so far showed favourable outcomes. Introduction of UTx into clinical practice may enable women with uterine infertility to have their own children.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Live donor uterus transplantation
Transplantation of uterus from a living donor. Immunosuppression with tacrolimus.
Live donor uterus transplantation
Transplantation of uterus from a living donor.
Tacrolimus
Maintenance immunosuppression in UTx recipient will be reduced to tacrolimus monotherapy to minimalize fetal compromise.
Deceased donor uterus transplantation
Transplantation of uterus from a deceased brain-dead donor. Immunosuppression with tacrolimus.
Deceased donor uterus transplantation
Transplantation of uterus from a deceased brain-dead donor.
Tacrolimus
Maintenance immunosuppression in UTx recipient will be reduced to tacrolimus monotherapy to minimalize fetal compromise.
Interventions
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Live donor uterus transplantation
Transplantation of uterus from a living donor.
Deceased donor uterus transplantation
Transplantation of uterus from a deceased brain-dead donor.
Tacrolimus
Maintenance immunosuppression in UTx recipient will be reduced to tacrolimus monotherapy to minimalize fetal compromise.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* good general health
* congenital or acquired uterus absence
* desire for a child
* female
* 18 - 60 years of age
* maximum 4 child births
* maximum 1 Cesarian section
* good general health
* female
* age under 60
* no previous hysterectomy
* no previous uterus malignancy
Exclusion Criteria
* serious comorbidity
* age over 60
* hypertension with organ damage
* diabetes mellitus
* other serious comorbidity
18 Years
60 Years
FEMALE
No
Sponsors
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University Hospital, Motol
OTHER
Sahlgrenska University Hospital
OTHER
Institute for Clinical and Experimental Medicine
OTHER_GOV
Responsible Party
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Jiri Fronek
MD PhD Assoc Prof
Principal Investigators
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Jiri Fronek, Assoc Prof
Role: PRINCIPAL_INVESTIGATOR
Transplant Surgery Department, Institute of Clinical and Experimental Medicine, Prague, Czech Republic
Locations
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Institute for Clinical and Experimental Medicine
Prague, , Czechia
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Olausson 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.
Johannesson 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.
Farrell 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.
Brannstrom 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.
Ozturk H. How real is the uterine transplantation? Ann Transplant. 2014 Feb 14;19:82-3. doi: 10.12659/AOT.889973. No abstract available.
Akar 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.
Fronek 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.
Related Links
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Uterine transplantation in the Czech Republic, description and contacts
Other Identifiers
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2044/15 (NM-15-01)
Identifier Type: -
Identifier Source: org_study_id
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