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  • Yan, Junhao; Qin, Yingying; Zhao, Han; Sun, Yun; Gong, Fei; Li, Rong; Sun, Xiaoxi; Ling, Xiufeng; Li, Hong; Hao, Cuifang; Tan, Jichun; Yang, Jing; Zhu, Yimin; Liu, Fenghua; Chen, Dawei; Wei, Daimin; Lu, Juanjuan; Ni, Tianxiang; Zhou, Wei; Wu, Keliang; Gao, Yuan; Shi, Yuhua; Lu, Yao; Zhang, Ting; Wu, Wei; Ma, Xiang; Ma, Hailan; Fu, Jing; Zhang, Junqiang; Meng, Qingxia; Zhang, Heping; Legro, Richard S; Chen, Zi-Jiang

    The New England journal of medicine, 11/2021, Letnik: 385, Številka: 22
    Journal Article

    Embryo selection with preimplantation genetic testing for aneuploidy (PGT-A) may improve pregnancy outcomes after initial embryo transfer. However, it remains uncertain whether PGT-A improves the cumulative live-birth rate as compared with conventional in vitro fertilization (IVF). In this multicenter, randomized, controlled trial, we randomly assigned subfertile women with three or more good-quality blastocysts to undergo either PGT-A or conventional IVF; all the women were between 20 and 37 years of age. Three blastocysts were screened by next-generation sequencing in the PGT-A group or were chosen by morphologic criteria in the conventional-IVF group and then were successively transferred one by one. The primary outcome was the cumulative live-birth rate after up to three embryo-transfer procedures within 1 year after randomization. We hypothesized that the use of PGT-A would result in a cumulative live-birth rate that was no more than 7 percentage points higher than the rate after conventional IVF, which would constitute the noninferiority margin for conventional IVF as compared with PGT-A. A total of 1212 patients underwent randomization, and 606 were assigned to each trial group. Live births occurred in 468 women (77.2%) in the PGT-A group and in 496 (81.8%) in the conventional-IVF group (absolute difference, -4.6 percentage points; 95% confidence interval CI, -9.2 to -0.0; P<0.001). The cumulative frequency of clinical pregnancy loss was 8.7% and 12.6%, respectively (absolute difference, -3.9 percentage points; 95% CI, -7.5 to -0.2). The incidences of obstetrical or neonatal complications and other adverse events were similar in the two groups. Among women with three or more good-quality blastocysts, conventional IVF resulted in a cumulative live-birth rate that was noninferior to the rate with PGT-A. (Funded by the National Natural Science Foundation of China and others; ClinicalTrials.gov number, NCT03118141.).