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A practical blueprint to systematically study life-long health consequences of novel medically assisted reproductive treatments
In medicine, safety and efficacy are the two pillars on which the implementation of novel treatments rest. To protect the patient from unnecessary or unsafe treatments, usually, a stringent path of (pre) clinical testing is followed before a treatment is introduced into routine patient care. However...
Autores principales: | , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Oxford University Press
2018
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5925779/ https://www.ncbi.nlm.nih.gov/pubmed/29635479 http://dx.doi.org/10.1093/humrep/dey070 |
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author | Mulder, Callista L Serrano, Joana B Catsburg, Lisa A E Roseboom, Tessa J Repping, Sjoerd van Pelt, Ans M M |
author_facet | Mulder, Callista L Serrano, Joana B Catsburg, Lisa A E Roseboom, Tessa J Repping, Sjoerd van Pelt, Ans M M |
author_sort | Mulder, Callista L |
collection | PubMed |
description | In medicine, safety and efficacy are the two pillars on which the implementation of novel treatments rest. To protect the patient from unnecessary or unsafe treatments, usually, a stringent path of (pre) clinical testing is followed before a treatment is introduced into routine patient care. However, in reproductive medicine several techniques have been clinically introduced without elaborate preclinical studies. Moreover, novel reproductive techniques may harbor safety risks not only for the patients undergoing treatment, but also for the offspring conceived through these techniques. If preclinical (animal) studies were performed, efficacy and functionality the upper hand. When a new medically assisted reproduction (MAR) treatment was proven effective (i.e. if it resulted in live birth) the treatment was often rapidly implemented in the clinic. For IVF, the first study on the long-term health of IVF children was published a decade after its clinical implementation. In more recent years, prospective follow-up studies have been conducted that provided the opportunity to study the health of large groups of children derived from different reproductive techniques. Although such studies have indicated differences between children conceived through MAR and children conceived naturally, results are often difficult to interpret due to the observational nature of these studies (and the associated risk of confounding factors, e.g. subfertility of the parents), differences in definitions of clinical outcome measures, lack of uniformity in assessment protocols and heterogeneity of the underlying reasons for fertility treatment. With more novel MARs waiting at the horizon, there is a need for a framework on how to assess safety of novel reproductive techniques in a preclinical (animal) setting before they are clinically implemented. In this article, we provide a blueprint for preclinical testing of safety and health of offspring generated by novel MARs using a mouse model involving an array of tests that comprise the entire lifespan. We urge scientists to perform the proposed extensive preclinical tests for novel reproductive techniques with the goal to acquire knowledge on efficacy and the possible health effects of to-be implemented reproductive techniques to safeguard quality of novel MARs. |
format | Online Article Text |
id | pubmed-5925779 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2018 |
publisher | Oxford University Press |
record_format | MEDLINE/PubMed |
spelling | pubmed-59257792018-05-04 A practical blueprint to systematically study life-long health consequences of novel medically assisted reproductive treatments Mulder, Callista L Serrano, Joana B Catsburg, Lisa A E Roseboom, Tessa J Repping, Sjoerd van Pelt, Ans M M Hum Reprod Opinion In medicine, safety and efficacy are the two pillars on which the implementation of novel treatments rest. To protect the patient from unnecessary or unsafe treatments, usually, a stringent path of (pre) clinical testing is followed before a treatment is introduced into routine patient care. However, in reproductive medicine several techniques have been clinically introduced without elaborate preclinical studies. Moreover, novel reproductive techniques may harbor safety risks not only for the patients undergoing treatment, but also for the offspring conceived through these techniques. If preclinical (animal) studies were performed, efficacy and functionality the upper hand. When a new medically assisted reproduction (MAR) treatment was proven effective (i.e. if it resulted in live birth) the treatment was often rapidly implemented in the clinic. For IVF, the first study on the long-term health of IVF children was published a decade after its clinical implementation. In more recent years, prospective follow-up studies have been conducted that provided the opportunity to study the health of large groups of children derived from different reproductive techniques. Although such studies have indicated differences between children conceived through MAR and children conceived naturally, results are often difficult to interpret due to the observational nature of these studies (and the associated risk of confounding factors, e.g. subfertility of the parents), differences in definitions of clinical outcome measures, lack of uniformity in assessment protocols and heterogeneity of the underlying reasons for fertility treatment. With more novel MARs waiting at the horizon, there is a need for a framework on how to assess safety of novel reproductive techniques in a preclinical (animal) setting before they are clinically implemented. In this article, we provide a blueprint for preclinical testing of safety and health of offspring generated by novel MARs using a mouse model involving an array of tests that comprise the entire lifespan. We urge scientists to perform the proposed extensive preclinical tests for novel reproductive techniques with the goal to acquire knowledge on efficacy and the possible health effects of to-be implemented reproductive techniques to safeguard quality of novel MARs. Oxford University Press 2018-05 2018-04-04 /pmc/articles/PMC5925779/ /pubmed/29635479 http://dx.doi.org/10.1093/humrep/dey070 Text en © The Author 2018. 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 | Opinion Mulder, Callista L Serrano, Joana B Catsburg, Lisa A E Roseboom, Tessa J Repping, Sjoerd van Pelt, Ans M M A practical blueprint to systematically study life-long health consequences of novel medically assisted reproductive treatments |
title | A practical blueprint to systematically study life-long health consequences of novel medically assisted reproductive treatments |
title_full | A practical blueprint to systematically study life-long health consequences of novel medically assisted reproductive treatments |
title_fullStr | A practical blueprint to systematically study life-long health consequences of novel medically assisted reproductive treatments |
title_full_unstemmed | A practical blueprint to systematically study life-long health consequences of novel medically assisted reproductive treatments |
title_short | A practical blueprint to systematically study life-long health consequences of novel medically assisted reproductive treatments |
title_sort | practical blueprint to systematically study life-long health consequences of novel medically assisted reproductive treatments |
topic | Opinion |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5925779/ https://www.ncbi.nlm.nih.gov/pubmed/29635479 http://dx.doi.org/10.1093/humrep/dey070 |
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