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Feasibility study for performing uterus transplantation in the Netherlands

STUDY QUESTION: Is it feasible to perform uterus transplantations (UTx) in a tertiary centre in the Netherlands? SUMMARY ANSWER: Considering all ethical principles, surgical risks and financial aspects, we have concluded that at this time, it is not feasible to establish the UTx procedure at our hos...

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Autores principales: Peters, H E, Juffermans, L J M, Lambalk, C B, Dekker, J J M L, Fernhout, T, Groenman, F A, de Groot, C J M, Hoksbergen, A W J, Huirne, J A F, de Leeuw, R A, van Mello, N M, Nederhoed, J H, Schats, R, Verhoeven, M O, Hehenkamp, W J K
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Oxford University Press 2020
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7048682/
https://www.ncbi.nlm.nih.gov/pubmed/32128452
http://dx.doi.org/10.1093/hropen/hoz032
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author Peters, H E
Juffermans, L J M
Lambalk, C B
Dekker, J J M L
Fernhout, T
Groenman, F A
de Groot, C J M
Hoksbergen, A W J
Huirne, J A F
de Leeuw, R A
van Mello, N M
Nederhoed, J H
Schats, R
Verhoeven, M O
Hehenkamp, W J K
author_facet Peters, H E
Juffermans, L J M
Lambalk, C B
Dekker, J J M L
Fernhout, T
Groenman, F A
de Groot, C J M
Hoksbergen, A W J
Huirne, J A F
de Leeuw, R A
van Mello, N M
Nederhoed, J H
Schats, R
Verhoeven, M O
Hehenkamp, W J K
author_sort Peters, H E
collection PubMed
description STUDY QUESTION: Is it feasible to perform uterus transplantations (UTx) in a tertiary centre in the Netherlands? SUMMARY ANSWER: Considering all ethical principles, surgical risks and financial aspects, we have concluded that at this time, it is not feasible to establish the UTx procedure at our hospital. WHAT IS KNOWN ALREADY: UTx is a promising treatment for absolute uterine factor infertility. It is currently being investigated within several clinical trials worldwide and has resulted in the live birth of 19 children so far. Most UTx procedures are performed in women with the Mayer–Rokitansky–Küster–Hauser (MRKH) syndrome, a congenital disorder characterized by absence of the uterus. In the Netherlands, the only possible option for these women for having children is adoption or surrogacy. STUDY DESIGN, SIZE, DURATION: We performed a feasibility study to search for ethical, medical and financial support for performing UTx at the Amsterdam UMC, location VUmc. PARTICIPANTS/MATERIALS, SETTING, METHODS: For this feasibility study, we created a special interest group, including gynaecologists, transplant surgeons, researchers and a financial advisor. Also, in collaboration with the patients’ association for women with MRKH, a questionnaire study was performed to research the decision-making in possible recipients. In this paper, we present an overview of current practices and literature on UTx and discuss the results of our feasibility study. MAIN RESULTS AND THE ROLE OF CHANCE: A high level of interest from the possible recipients became apparent from our questionnaire amongst women with MRKH. The majority (64.8%) positively considered UTx with a live donor, with 69.6% having a potential donor available. However, this ‘non-life-saving transplantation’ requires careful balancing of risks and benefits. The UTx procedure includes two complex surgeries and unknown consequences for the unborn child. The costs for one UTx are calculated to be around €100 000 and will not be compensated by medical insurance. The Clinical Ethics Committee places great emphasis on the principle of non-maleficence and the ‘fair distribution of health services’. LIMITATIONS, REASONS FOR CAUTION: In the Netherlands, alternatives for having children are available and future collaboration with experienced foreign clinics that offer the procedure is a possibility not yet investigated. WIDER IMPLICATIONS OF THE FINDINGS: The final assessment of this feasibility study is that that there are not enough grounds to support this procedure at our hospital at this point in time. We will closely follow the developments and will re-evaluate the feasibility in the future. STUDY FUNDING/COMPETING INTEREST(S): This feasibility study was funded by the VU Medical Center (Innovation grant 2017). No conflicts of interest have been reported relevant to the subject of all authors. TRIAL REGISTRATION NUMBER: n.a
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spelling pubmed-70486822020-03-03 Feasibility study for performing uterus transplantation in the Netherlands Peters, H E Juffermans, L J M Lambalk, C B Dekker, J J M L Fernhout, T Groenman, F A de Groot, C J M Hoksbergen, A W J Huirne, J A F de Leeuw, R A van Mello, N M Nederhoed, J H Schats, R Verhoeven, M O Hehenkamp, W J K Hum Reprod Open Original Article STUDY QUESTION: Is it feasible to perform uterus transplantations (UTx) in a tertiary centre in the Netherlands? SUMMARY ANSWER: Considering all ethical principles, surgical risks and financial aspects, we have concluded that at this time, it is not feasible to establish the UTx procedure at our hospital. WHAT IS KNOWN ALREADY: UTx is a promising treatment for absolute uterine factor infertility. It is currently being investigated within several clinical trials worldwide and has resulted in the live birth of 19 children so far. Most UTx procedures are performed in women with the Mayer–Rokitansky–Küster–Hauser (MRKH) syndrome, a congenital disorder characterized by absence of the uterus. In the Netherlands, the only possible option for these women for having children is adoption or surrogacy. STUDY DESIGN, SIZE, DURATION: We performed a feasibility study to search for ethical, medical and financial support for performing UTx at the Amsterdam UMC, location VUmc. PARTICIPANTS/MATERIALS, SETTING, METHODS: For this feasibility study, we created a special interest group, including gynaecologists, transplant surgeons, researchers and a financial advisor. Also, in collaboration with the patients’ association for women with MRKH, a questionnaire study was performed to research the decision-making in possible recipients. In this paper, we present an overview of current practices and literature on UTx and discuss the results of our feasibility study. MAIN RESULTS AND THE ROLE OF CHANCE: A high level of interest from the possible recipients became apparent from our questionnaire amongst women with MRKH. The majority (64.8%) positively considered UTx with a live donor, with 69.6% having a potential donor available. However, this ‘non-life-saving transplantation’ requires careful balancing of risks and benefits. The UTx procedure includes two complex surgeries and unknown consequences for the unborn child. The costs for one UTx are calculated to be around €100 000 and will not be compensated by medical insurance. The Clinical Ethics Committee places great emphasis on the principle of non-maleficence and the ‘fair distribution of health services’. LIMITATIONS, REASONS FOR CAUTION: In the Netherlands, alternatives for having children are available and future collaboration with experienced foreign clinics that offer the procedure is a possibility not yet investigated. WIDER IMPLICATIONS OF THE FINDINGS: The final assessment of this feasibility study is that that there are not enough grounds to support this procedure at our hospital at this point in time. We will closely follow the developments and will re-evaluate the feasibility in the future. STUDY FUNDING/COMPETING INTEREST(S): This feasibility study was funded by the VU Medical Center (Innovation grant 2017). No conflicts of interest have been reported relevant to the subject of all authors. TRIAL REGISTRATION NUMBER: n.a Oxford University Press 2020-02-28 /pmc/articles/PMC7048682/ /pubmed/32128452 http://dx.doi.org/10.1093/hropen/hoz032 Text en © The Author(s) 2020. Published by Oxford University Press on behalf of the European Society of Human Reproduction and Embryology. http://creativecommons.org/licenses/by-nc/4.0/ This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/4.0/), which permits non-commercial re-use, distribution, and reproduction in any medium, provided the original work is properly cited. For commercial re-use, please contact journals.permissions@oup.com
spellingShingle Original Article
Peters, H E
Juffermans, L J M
Lambalk, C B
Dekker, J J M L
Fernhout, T
Groenman, F A
de Groot, C J M
Hoksbergen, A W J
Huirne, J A F
de Leeuw, R A
van Mello, N M
Nederhoed, J H
Schats, R
Verhoeven, M O
Hehenkamp, W J K
Feasibility study for performing uterus transplantation in the Netherlands
title Feasibility study for performing uterus transplantation in the Netherlands
title_full Feasibility study for performing uterus transplantation in the Netherlands
title_fullStr Feasibility study for performing uterus transplantation in the Netherlands
title_full_unstemmed Feasibility study for performing uterus transplantation in the Netherlands
title_short Feasibility study for performing uterus transplantation in the Netherlands
title_sort feasibility study for performing uterus transplantation in the netherlands
topic Original Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7048682/
https://www.ncbi.nlm.nih.gov/pubmed/32128452
http://dx.doi.org/10.1093/hropen/hoz032
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