From the Center for Reproductive Medicine, Cheeloo College of Medicine, Key Laboratory of Reproductive Endocrinology of the Ministry of Education, and the National Research Center for Assisted Reproductive Technology and Reproductive Genetics, Shandong University, Shandong Key Laboratory of Reproductive Medicine, and Shandong Provincial Clinical Research Center for Reproductive Health, Jinan (J.Y., Y.Q., H.Z., D.W., J.L., T.N., W.Z., K.W., Y.G., Y.S., Z.-J.C.), the Center for Reproductive Medicine, Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai Key Laboratory for Assisted Reproduction and Reproductive Genetics (Y.S., Z.-J.C., Y.L., T.Z.), and the Obstetrics and Gynecology Hospital of Fudan University, Shanghai JIAI Genetics and IVF Institute, Key Laboratory of Female Reproductive Endocrine Related Diseases, Obstetrics and Gynecology Hospital of Fudan University (X.S., J.F.), Shanghai, the Institute of Reproductive and Stem Cell Engineering, School of Basic Medical Science, Central South University, and Reproductive and Genetic Hospital of CITIC-Xiangya, Changsha (F.G., H.M.), the Center for Reproductive Medicine, Department of Obstetrics and Gynecology, Peking University Third Hospital, National Clinical Research Center for Obstetrics and Gynecology, Key Laboratory of Assisted Reproduction, Ministry of Education, and Beijing Key Laboratory of Reproductive Endocrinology and Assisted Reproductive Technology, Beijing (R.L.), the Department of Reproductive Medicine, the Affiliated Obstetrics and Gynecology Hospital with Nanjing Medical University, Nanjing Maternity and Child Health Care Hospital (X.L., J.Z.), and the Department of Reproductive Medicine, First Affiliated Hospital of Nanjing Medical University-Jiangsu Province Hospital (X.M., W.W.), Nanjing, the Affiliated Suzhou Hospital of Nanjing Medical University, Suzhou Municipal Hospital, Suzhou (H.L., Q.M.), the Center for Reproductive Medicine of Yantai Yuhuangding Hospital, Yantai (C.H.), the Center of Reproductive Medicine, Department of Obstetrics and Gynecology, Shengjing Hospital of China Medical University, Key Laboratory of Reproductive Dysfunction Diseases and Fertility Remodeling of Liaoning Province, Shenyang (J.T.), the Center for Reproductive Medicine, Wuhan University, Wuhan (J.Y.), the Department of Reproductive Endocrinology, Key Laboratory of Reproductive Genetics, Ministry of Education, Women's Reproductive Health Laboratory of Zhejiang Province, Women's Hospital, Zhejiang University School of Medicine, Hangzhou (Y.Z.), the Department of Reproductive Health and Infertility, Guangdong Women and Children Hospital, Guangzhou (F.L.), and the Reproductive Medicine Center, Department of Obstetrics and Gynecology, the First Affiliated Hospital of Anhui Medical University, Hefei (D.C.) - all in China; the Department of Biostatistics, Yale University School of Public Health, New Haven, CT (H.Z.); and the Department of Obstetrics and Gynecology, Penn State College of Medicine, Hershey, PA (R.S.L.).
N Engl J Med. 2021 Nov 25;385(22):2047-2058. doi: 10.1056/NEJMoa2103613.
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.).
胚胎植入前遗传学检测（PGT-A）选择胚胎可改善初始胚胎移植后的妊娠结局。然而，PGT-A 是否比传统体外受精（IVF）更能提高累积活产率仍不确定。
在这项多中心、随机、对照试验中，我们将 3 个或更多优质囊胚的不孕女性随机分为 PGT-A 组或常规 IVF 组；所有女性年龄均在 20 至 37 岁之间。PGT-A 组通过下一代测序对 3 个囊胚进行筛查，或常规-IVF 组通过形态学标准选择，并随后依次逐个转移。主要结局是在随机分组后 1 年内进行的最多 3 次胚胎移植后累积活产率。我们假设 PGT-A 的使用累积活产率不会比传统 IVF 高超过 7 个百分点，这将构成传统 IVF 与 PGT-A 相比的非劣效性边缘。
共有 1212 名患者接受了随机分组，每组 606 名。PGT-A 组有 468 名（77.2%）女性活产，常规-IVF 组有 496 名（81.8%）（绝对差异，-4.6 个百分点；95%置信区间[CI]，-9.2 至 -0.0；P<0.001）。临床妊娠丢失的累积频率分别为 8.7%和 12.6%（绝对差异，-3.9 个百分点；95%CI，-7.5 至 -0.2）。两组的产科或新生儿并发症及其他不良事件发生率相似。
在有 3 个或更多优质囊胚的女性中，常规 IVF 的累积活产率不劣于 PGT-A。（由国家自然科学基金等资助；ClinicalTrials.gov 编号，NCT03118141。）
