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Hum. Reprod. Advance Access originally published online on November 19, 2007
Human Reproduction 2008 23(1):1-3; doi:10.1093/humrep/dem378
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© The Author 2007. Published by Oxford University Press on behalf of the European Society of Human Reproduction and Embryology. All rights reserved. For Permissions, please email: journals.permissions@oxfordjournals.org

OPINION

IVF with preimplantation genetic screening, a promising new treatment with unexpectedly negative health outcomes: the Hippocratic role of Data Monitoring Committees

Willem M. Ankum1,4, Johannes B. Reitsma2 and Martin Offringa3

1 Department of Obstetrics and Gynaecology, Academic Medical Centre, University of Amsterdam, the Netherlands 2 Department of Clinical Epidemiology and Biostatistics, Academic Medical Centre, University of Amsterdam, the Netherlands 3 Department of Paediatric Clinical Epidemiology, Academic Medical Centre, University of Amsterdam, the Netherlands

4 Correspondence address. E-mail: w.m.ankum{at}amc.uva.nl

A recently published randomized controlled trial showed preimplantation genetic screening (PGS) as part of an IVF programme to reduce ongoing pregnancy rates by 1/3 in comparison to the control group without PGS: rate ratio (RR) 0.69 (0.51–0.93), P = 0.01. A masked interim analysis already showed significant differences between treatment arms: RR 0.58 (0.35–0.94), P = 0.02. Despite this finding, the trial's Data Monitoring Committee decided not to stop, but to continue the trial. This paper argues why this decision was sound, since it was based on (i) explicit statistical criteria and (ii) the trade-off between risks and benefits for current and future IVF patients. The trial's findings confront the medical community once again with the general problem of new technologies being implemented without randomized evidence of effectiveness.

Key words: IVF/preimplantation genetic screening/masked interim analysis/Data Monitoring Committee/randomized controlled trial


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