Mayer Rokitansky Kuster Hauser SyndromePhase 3UTxLD/DBDNCT03277430
Uterus Transplantation From Live Donors and From Deceased Donors - Clinical Study
A Phase 3 study testing Live donor uterus transplantation, Deceased donor uterus transplantation and Tacrolimus in people with Mayer Rokitansky Kuster Hauser Syndrome and Mullerian Aplasia, run by Institute for Clinical and Experimental Medicine at 1 site in Czechia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women only
- Conditions the study is for
- Mayer Rokitansky Kuster Hauser Syndrome, Mullerian Aplasia, Uterus; Absence, Congenital
- What is being tested?
- Live donor uterus transplantation, Deceased donor uterus transplantation and Tacrolimus
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteCzechia
- Study dates
- 9 Oct 2015to 31 Dec 2025
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 18 - 40 years of age
- good general health
- congenital or acquired uterus absence
- desire for a child
- female
- 18 - 60 years of age
Show all 13Show fewer
- maximum 4 child births
- maximum 1 Cesarian section
- good general health
- female
- age under 60
- no previous hysterectomy
- no previous uterus malignancy
Who cannot join
- age over 40
- serious comorbidity
- age over 60
- hypertension with organ damage
- diabetes mellitus
- other serious comorbidity
Trial locations and contacts
1 site in 1 country.
Czechia1 site, 1 recruiting
- Recruiting
Institute for Clinical and Experimental Medicine
Prague, 14021
Jiri Fronek, Assoc Prof, +420 26 136 4105, jifr@ikem.cz
Renata Zamecnikova, Bc, +420 26 136 4105, zamr@ikem.cz
About this study
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.
Read the detailed description
Introduction: Uterus transplantation (UTx) is the only causative treatment for congenital or acquired uterus absence, i.e. absolute uterine factor infertility (AUFI). Feasibility of uterus transplantation from o live donor and possibility of healthy child birth have been proven in previous clinical study in Sweden. The present study is supposed to extend the swedish experience by including UTx from both live donors and from deceased donors after brain death.
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
- Mayer Rokitansky Kuster Hauser Syndrome, Mullerian Aplasia, Uterus; Absence, Congenital, Infertility, Female, Uterus Absence, Acquired, Absolute Uterine Factor Infertility
- Being tested
- Live donor uterus transplantation, Deceased donor uterus transplantation, Tacrolimus
- Keywords
- uterus transplantation, absolute uterine factor infertility
- Medical subject headings
- Mullerian aplasia, Infertility, Female
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Live donor uterus transplantationProcedure or surgery
Transplantation of uterus from a living donor.
Deceased donor uterus transplantationProcedure or surgery
Transplantation of uterus from a deceased brain-dead donor.
TacrolimusDrug
Also called FK506
Maintenance immunosuppression in UTx recipient will be reduced to tacrolimus monotherapy to minimalize fetal compromise.
| Study group | Role | What they receive |
|---|---|---|
| Live donor uterus transplantation | Experimental | Transplantation of uterus from a living donor. Immunosuppression with tacrolimus. Receives: Procedure: Live donor uterus transplantation; Drug: Tacrolimus |
| Deceased donor uterus transplantation | Experimental | Transplantation of uterus from a deceased brain-dead donor. Immunosuppression with tacrolimus. Receives: Procedure: Deceased donor uterus transplantation; Drug: Tacrolimus |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Number of successful uterus transplantations and healthy child births from live donors versus deceased donors.
Measured: Until 10 live donor and 10 deceased donor uterus transplants have been performed plus approximately 5 years.
Rate of adverse events after uterus transplantation
Number of recipients of uterus transplantation with adverse events.
Measured: 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
Number of live donor participants after uterus retrieval with adverse events.
Measured: Until 10 live donor transplants have been performed plus approximately 5 years.
Rate of adverse events during pregnancy and child birth after uterus transplantation
Number of children conceived and born from transplanted uterus with adverse events.
Measured: Until 10 live donor and 10 deceased donor uterus transplants have been performed plus approximately 5 years.
Verification of technique of uterus retrieval
Verification of surgical technique of uterus retrieval from a live donor and from a deceased donor.
Measured: Until 10 live donor and 10 deceased donor uterus transplants have been performed plus approximately 5 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2017
- Study start9 Oct 2015
- Primary completion31 Dec 2020 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Mayer Rokitansky Kuster Hauser SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institute for Clinical and Experimental Medicine
- Sponsor type
- Other government
- Collaborators
- University Hospital, Motol, Sahlgrenska University Hospital
- Responsible party
- Principal investigator, Jiri Fronek, Institute for Clinical and Experimental Medicine
- Investigators
- Jiri Fronek, Assoc Prof, Principal investigator, Transplant Surgery Department, Institute of Clinical and Experimental Medicine, Prague, Czech Republic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03277430
- Sponsor's protocol ID
- 2044/15 (NM-15-01)
- Acronym
- UTxLD/DBD
- Status last verified
- Feb 2019
- First submitted
- 4 Sep 2017
- Last updated
- 27 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 25226847Olausson 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.
PubMed 24784936Johannesson 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.
PubMed 25259905Farrell 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.
PubMed 24726215Brannstrom 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.
PubMed 24582522Ozturk H. How real is the uterine transplantation? Ann Transplant. 2014 Feb 14;19:82-3. doi: 10.12659/AOT.889973. No abstract available.
PubMed 24535028Akar 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.
PubMed 24992779Fronek 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.
PubMed 32541565
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Uterus Transplantation From Live Donors and From Deceased Donors - Clinical Study
- ClinicalTrials.gov ID
- NCT03277430
- Acronym / sponsor ID
- UTxLD/DBD / 2044/15 (NM-15-01)
- Conditions
- Mayer Rokitansky Kuster Hauser Syndrome, Mullerian Aplasia, Uterus; Absence, Congenital, Infertility, Female, Uterus Absence, Acquired, Absolute Uterine Factor Infertility
- Keywords
- uterus transplantation, absolute uterine factor infertility
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Institute for Clinical and Experimental MedicineOther government
- Collaborators
- University Hospital, Motol, Sahlgrenska University Hospital
- Study start
- 9 Oct 2015 (actual)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 11 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Introduction: Uterus transplantation (UTx) is the only causative treatment for congenital or acquired uterus absence, i.e. absolute uterine factor infertility (AUFI). Feasibility of uterus transplantation from o live donor and possibility of healthy child birth have been proven in previous clinical study in Sweden. The present study is supposed to extend the swedish experience by including UTx from both live donors and from deceased donors after brain death.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Live donor uterus transplantation | Experimental | Procedure: Live donor uterus transplantation, Drug: TacrolimusTransplantation of uterus from a living donor. Immunosuppression with tacrolimus. |
| Deceased donor uterus transplantation | Experimental | Procedure: Deceased donor uterus transplantation, Drug: TacrolimusTransplantation of uterus from a deceased brain-dead donor. Immunosuppression with tacrolimus. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (13 listed)
- 18 - 40 years of age
- good general health
- congenital or acquired uterus absence
- desire for a child
- female
Key exclusion criteria (6 listed)
- age over 40
- serious comorbidity
- age over 60
- hypertension with organ damage
- diabetes mellitus
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Live donor uterus transplantationTransplantation of uterus from a living donor. | Procedure or surgery | Live donor uterus transplantation |
| Deceased donor uterus transplantationTransplantation of uterus from a deceased brain-dead donor. | Procedure or surgery | Deceased donor uterus transplantation |
| TacrolimusAlso: FK506Maintenance immunosuppression in UTx recipient will be reduced to tacrolimus monotherapy to minimalize fetal compromise. | Drug | Deceased donor uterus transplantation, Live donor uterus transplantation |
Primary outcome
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.
5 secondary outcomes
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.
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.
Rate of adverse events after live uterus donation
Time frame: Until 10 live donor transplants have been performed plus approximately 5 years.
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.
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2019.
- Background: PubMed 25226847Erman 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.
- Background: PubMed 24784936Olausson 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.
- Background: PubMed 25259905Johannesson 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.
- Background: PubMed 24726215Farrell 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.
- Background: PubMed 24582522Brannstrom 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.
- Background: PubMed 24535028Ozturk H. How real is the uterine transplantation? Ann Transplant. 2014 Feb 14;19:82-3. doi: 10.12659/AOT.889973. No abstract available.
- Background: PubMed 24992779Akar 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.
- Derived from this study: PubMed 32541565Fronek 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.
- Uterine transplantation in the Czech Republic, description and contactsLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jiri Fronek, Assoc Prof principal investigator
Transplant Surgery Department, Institute of Clinical and Experimental Medicine, Prague, Czech Republic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Live donor uterus transplantation, Deceased donor uterus transplantation and Tacrolimus in people with Mayer Rokitansky Kuster Hauser Syndrome and Mullerian Aplasia, run by Institute for Clinical and Experimental Medicine at 1 site in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jiri Fronek, Assoc Prof (+420 26 136 4105, jifr@ikem.cz), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy of uterus transplantation. (time frame: Until 10 live donor and 10 deceased donor uterus transplants have been performed plus approximately 5 years.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03277430, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2019.