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Hum. Reprod. Advance Access originally published online on June 25, 2008
Human Reproduction 2008 23(12):2806-2812; doi:10.1093/humrep/den217
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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

Preimplantation genetic screening in women of advanced maternal age caused a decrease in clinical pregnancy rate: a randomized controlled trial

T. Hardarson1,3, C. Hanson2, K. Lundin2, T. Hillensjö1, L. Nilsson2, J. Stevic2, E. Reismer1, K. Borg1, M. Wikland1 and C. Bergh2

1 Fertility Centre Scandinavia, Carlanderska Hospital, Box 5418, 402 29 Göteborg, Sweden 2 Department of Reproductive Medicine, Sahlgrenska University Hospital, 413 45 Göteborg, Sweden

3 Correspondence address. E-mail: thorir.hardarson{at}fcivf.com

BACKGROUND: Advanced maternal age (AMA) is an important parameter that negatively influences the clinical pregnancy rate in IVF, in particular owing to the increased embryo aneuploidy rate. It has thus been suggested that only transferring euploid embryos in this patient group would improve the pregnancy rate. The purpose of this study was to test whether employing preimplantation genetic screening (PGS) in AMA patients would increase the clinical pregnancy rate.

METHODS: We conducted a two-center, randomized controlled trial (RCT) to analyze the outcome of embryo transfers in AMA patients (≥38 years of age) after PGS using FISH analysis for chromosomes X, Y, 13, 16, 18, 21 and 22. The PGS group was compared with a control group. The primary outcome measure was clinical pregnancy rate after 6–7 weeks of gestation per randomized patient.

RESULTS: The study was terminated early as an interim analysis showed a very low conditional power of superiority for the primary outcome. Of the 320 patients calculated to be included in the study, 56 and 53 patients were randomized into the PGS and control groups, respectively. The clinical pregnancy rate in the PGS group was 8.9% (95% CI, 2.9–19.6%) compared with 24.5% (95% CI, 13.8–38.3%) in the control group, giving a difference of 15.6% (95% CI, 1.8–29.4%, P = 0.039).

CONCLUSIONS: Although the study was terminated early, this RCT study provides evidence against the use of PGS for AMA patients when performing IVF. Trial registration number: ISRCTN38014610 [controlled-trials.com] .

Key words: AMA/PGS/embryo biopsy/RCT/IVF

Submitted on December 31, 2007; resubmitted on May 6, 2008; accepted on May 13, 2008.


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