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Hum. Reprod. Advance Access published online on July 9, 2008
Human Reproduction, doi:10.1093/humrep/den250
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© The Author 2008. 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

Randomized clinical trial in assessing PGS: necessary but not sufficient

Joe Leigh Simpson1

College of Medicine, Florida International University, Building HLS II, Room 672, Miami, FL 33315, USA

1 Correspondence address. Tel: +1-305-348-0613; Fax: +1-305-348-0651; E-mail: simpsonj{at}fiu.edu

The randomized clinical trial (RCT) is a powerful experimental design that when properly executed produces generalizable results. Conducting a RCT becomes complex when technical skills are required. Without requisite skills, a RCT may yield misleading results, an elegant RCT unwittingly generating spurious results due to technical inexperience. This pitfall is applicable to procedures used to evaluate assisted reproductive technologies. RCTs assessing the value of preimplantation genetic screening, also called preimplantation genetic diagnosis for aneuploidy testing—require three general prerequisites—proper study design, skilled operators (embryo biopsy), and skilled laboratory cytogeneticists (diagnosis). Lacking either of the latter two, even an elegantly designed RCT is not necessarily valid.

Submitted on December 21, 2007; resubmitted on April 21, 2008; accepted on May 22, 2008.


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