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

TLDR

Advanced maternal age lowers IVF clinical pregnancy rates mainly because of higher embryo aneuploidy. The study aimed to determine whether preimplantation genetic screening could raise the clinical pregnancy rate in women aged 38 or older. A two‑center randomized controlled trial assigned 56 patients to PGS (FISH for chromosomes X, Y, 13, 16, 18, 21, 22) and 53 to control, measuring clinical pregnancy at 6–7 weeks and terminating early due to low conditional power. Clinical pregnancy occurred in 8.9 % of the PGS group versus 24.5 % of controls, a 15.6 % difference (p = 0.039), indicating that PGS does not improve outcomes for advanced‑maternal‑age IVF.

Abstract

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.We conducted a two-center, randomized controlled trial (RCT) to analyze the outcome of embryo transfers in AMA patients (>or=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.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).Although the study was terminated early, this RCT study provides evidence against the use of PGS for AMA patients when performing IVF.ISRCTN38014610.