Selecting single euploid blastocysts for transfer with NGS significantly improves IVF treatment outcomes: a randomized study

Abstract

Introduction Recent advancements in whole genomic amplification (WGA) and next-generation sequencing (NGS) have provided new methods for preimplantation genetic testing for aneuploidy (PGT-A) of human embryos derived from in vitro fertilization (IVF) cycles. The present study aimed to investigate the effects of NGS on clinical and ongoing pregnancy outcomes of single embryo transfer (SET) for IVF patients with a good prognosis. Material and Methods A total of 247 IVF patients at mean age 31.4 ± 3.2 years who met the inclusion criteria (under 35 years old with normal uterine lining and normal karyotype) were randomized into two groups: 1) Group A (MA+NGS): patients (n=124) had blastocysts evaluated with morphological assessment (MA) and analyzed with NGS (Yikon Genomics, China; Illumina, USA) and 2) Group B (MA): patients (n=123) had blastocysts evaluated with morphological assessment (MA) only. One blastocyst was selected and transferred to individual patients based on NGS and morphological assessment (Group A) or morphological assessment alone (Group B). Clinical and ongoing pregnancy (≥20 weeks of gestation) rates were compared between the two groups. Results There were no significant differences in female patient's mean age, Day 3 FSH, AMH, E2, antral follicle number between the two groups (p>0.05). NGS identified single euploid blastocysts for transfer and resulted in significantly higher clinical pregnancy rates per transfer in Group A compared to morphological assessment alone in Group B (71.7% vs. 52.1%, respectively, p =0.001). The ongoing pregnancy rates per transfer also significantly increased in Group A compared to Group B (69.2% vs. 46.3%, respectively, p =0.002). There were no twin or multiple pregnancies in both groups. Conclusions While NGS has been recently introduced to IVF treatment, this is the first randomized clinical study showing that there is clinical benefit of NGS for selecting single blastocysts for transfer for good prognosis patients in comparison to morphology assessment alone. With the observed high accuracy of 24-chromosome testing and the improved clinical and ongoing pregnancy outcomes, NGS has demonstrated an efficient, robust high-throughput technology for selecting single blastocysts for transfer for IVF patients with a good prognosis to reduce multiple pregnancies.