Feasibility study for performing uterus transplantation in the Netherlands

H E Peters; L J M Juffermans; C B Lambalk; J J M L Dekker; T Fernhout; F A Groenman; C J M de Groot; A W J Hoksbergen; J A F Huirne; R A de Leeuw; N M van Mello; J H Nederhoed; R Schats; M O Verhoeven; W J K Hehenkamp

doi:https://doi.org/10.1093/hropen/hoz032

Feasibility study for performing uterus transplantation in the Netherlands

H E Peters, L J M Juffermans, C B Lambalk, J J M L Dekker, T Fernhout, F A Groenman, C J M de Groot, A W J Hoksbergen, J A F Huirne, R A de Leeuw, N M van Mello, J H Nederhoed, R Schats, M O Verhoeven, W J K Hehenkamp

Research output: Contribution to journal › Article › Academic › peer-review

Abstract

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 INTERESTS: 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.

Original language	English
Pages (from-to)	hoz032
Journal	Human reproduction open
Volume	2020
Issue number	2
DOIs	https://doi.org/10.1093/hropen/hoz032
Publication status	Published - 2020

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https://doi.org/10.1093/hropen/hoz032

Cite this

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. (2020). Feasibility study for performing uterus transplantation in the Netherlands. Human reproduction open, 2020(2), hoz032. https://doi.org/10.1093/hropen/hoz032

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title = "Feasibility study for performing uterus transplantation in the Netherlands",

abstract = "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-K{\"u}ster-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 INTERESTS: 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.",

author = "Peters, {H E} and Juffermans, {L J M} and Lambalk, {C B} and Dekker, {J J M L} and T Fernhout and Groenman, {F A} and {de Groot}, {C J M} and Hoksbergen, {A W J} and Huirne, {J A F} and {de Leeuw}, {R A} and {van Mello}, {N M} and Nederhoed, {J H} and R Schats and Verhoeven, {M O} and Hehenkamp, {W J K}",

note = "{\textcopyright} The Author(s) 2020. Published by Oxford University Press on behalf of the European Society of Human Reproduction and Embryology.",

year = "2020",

doi = "https://doi.org/10.1093/hropen/hoz032",

language = "English",

volume = "2020",

pages = "hoz032",

journal = "Human reproduction open",

issn = "2399-3529",

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Peters, HE, Juffermans, LJM , Lambalk, CB , Dekker, JJML, Fernhout, T, Groenman, FA , de Groot, CJM , Hoksbergen, AWJ , Huirne, JAF , de Leeuw, RA , van Mello, NM , Nederhoed, JH, Schats, R, Verhoeven, MO & Hehenkamp, WJK 2020, 'Feasibility study for performing uterus transplantation in the Netherlands', Human reproduction open, vol. 2020, no. 2, pp. hoz032. https://doi.org/10.1093/hropen/hoz032

TY - JOUR

T1 - Feasibility study for performing uterus transplantation in the Netherlands

AU - Peters, H E

AU - Juffermans, L J M

AU - Lambalk, C B

AU - Dekker, J J M L

AU - Fernhout, T

AU - Groenman, F A

AU - de Groot, C J M

AU - Hoksbergen, A W J

AU - Huirne, J A F

AU - de Leeuw, R A

AU - van Mello, N M

AU - Nederhoed, J H

AU - Schats, R

AU - Verhoeven, M O

AU - Hehenkamp, W J K

N1 - © The Author(s) 2020. Published by Oxford University Press on behalf of the European Society of Human Reproduction and Embryology.

PY - 2020

Y1 - 2020

N2 - 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 INTERESTS: 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.

AB - 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 INTERESTS: 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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DO - https://doi.org/10.1093/hropen/hoz032

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SN - 2399-3529

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JO - Human reproduction open

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