排卵女性中新鲜胚胎与冷冻胚胎的移植。

Transfer of Fresh versus Frozen Embryos in Ovulatory Women.

机构信息

From the Center for Reproductive Medicine, Shandong Provincial Hospital-Shandong University, the Key Laboratory of Reproductive Endocrinology of Ministry of Education, and the National Research Center for Assisted Reproductive Technology and Reproductive Genetics (Y. Shi, D.W., Z.W., M.S. H. Liu, J.L., L.Z., Z.-J.C.), and the Center for Reproductive Medicine, Qilu Hospital of Shandong University (X.D.), Jinan, the Center for Reproductive Medicine, Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University, and Shanghai Key Laboratory of Assisted Reproduction and Reproductive Genetics (Y. Sun, Z.-J.C.), and the Shanghai Jiai Genetic and IVF Center, Obstetrics and Gynecology Hospital, Fudan University (X.S.), Shanghai, the Center for Reproductive Medicine of Yantai Yuhuangding Hospital, Yantai (C.H.), the Center for Reproductive Medicine, Tianjin Central Hospital of Obstetrics and Gynecology, Tianjin (Y. Zhang), the Department of Reproductive Endocrinology, Women's Hospital (Y. Zhu, D.Z.), and the Center for Reproductive Medicine (S.Z.), School of Medicine, Zhejiang University, Hangzhou, the Affiliated Hospital of Qingdao University (X.Q.) and the Center for Reproductive Medicine, Qingdao Women and Children's Hospital-Qingdao University (Y. Zhou), Qingdao, the Center for Reproduction and Genetics, Suzhou Municipal Hospital, Suzhou (H. Li), the Department of Reproductive Medicine, First Affiliated Hospital of Nanjing Medical University-Jiangsu Province Hospital, Nanjing, (X.M.), the Reproductive Medicine Center of Jinghua Hospital, Shenyang (H.R.), the Center for Reproductive Medicine, Wuhan University, Wuhan (Y.W.), the Reproductive Medicine Research Center, 6th Affiliated Hospital of Sun Yat-sen University (B.W.), the Center for Reproductive Medicine, Women and Children's Hospital of Guangdong Province (F.L.), and the Center for Reproductive Medicine, Sun Yat-sen Memorial Hospital of Sun Yat-sen University (X.C.), Guangzhou, the Center for Reproductive Medicine, Maternal and Child Health Care Hospital of Jiangxi Province, Nanchang (Q.W.), the Center for Assisted Reproduction, Northwest Women and Children's Hospital, Xi'an (H.B.), and the Center for Reproductive Medicine, Beijing Chaoyang Hospital, Beijing (Y.L.) - 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.).

出版信息

N Engl J Med. 2018 Jan 11;378(2):126-136. doi: 10.1056/NEJMoa1705334.

DOI:10.1056/NEJMoa1705334

PMID:29320646

Abstract

BACKGROUND

Elective frozen-embryo transfer has been shown to result in a higher live-birth rate than fresh-embryo transfer among anovulatory women with the polycystic ovary syndrome. It is uncertain whether frozen-embryo transfer increases live-birth rates among ovulatory women with infertility.

METHODS

In this multicenter, randomized trial, we randomly assigned 2157 women who were undergoing their first in vitro fertilization cycle to undergo either fresh-embryo transfer or embryo cryopreservation followed by frozen-embryo transfer. Up to two cleavage-stage embryos were transferred in each participant. The primary outcome was a live birth after the first embryo transfer.

RESULTS

The live-birth rate did not differ significantly between the frozen-embryo group and the fresh-embryo group (48.7% and 50.2%, respectively; relative risk, 0.97; 95% confidence interval [CI], 0.89 to 1.06; P=0.50). There were also no significant between-group differences in the rates of implantation, clinical pregnancy, overall pregnancy loss, and ongoing pregnancy. Frozen-embryo transfer resulted in a significantly lower risk of the ovarian hyperstimulation syndrome than fresh-embryo transfer (0.6% vs. 2.0%; relative risk, 0.32; 95% CI, 0.14 to 0.74; P=0.005). The risks of obstetrical and neonatal complications and other adverse outcomes did not differ significantly between the two groups.

CONCLUSIONS

The live-birth rate did not differ significantly between fresh-embryo transfer and frozen-embryo transfer among ovulatory women with infertility, but frozen-embryo transfer resulted in a lower risk of the ovarian hyperstimulation syndrome. (Funded by the National Key Research and Development Program of China and the National Natural Science Foundation of China; Chinese Clinical Trial Registry number, ChiCTR-IOR-14005406 .).

摘要

背景

与排卵障碍性多囊卵巢综合征患者相比，对于排卵正常的不孕女性，选择性冻融胚胎移植可提高活产率。然而，冻融胚胎移植是否能提高排卵正常的不孕女性的活产率尚不清楚。

方法

本多中心随机试验纳入了 2157 名首次接受体外受精的女性患者，将其随机分配至新鲜胚胎移植组或胚胎冷冻保存后行冻融胚胎移植组。每组患者均移植 2 枚或 2 枚以下卵裂期胚胎。主要结局为首次胚胎移植后的活产。

结果

冻融胚胎移植组与新鲜胚胎移植组的活产率无显著差异（分别为 48.7%和 50.2%；相对危险度为 0.97；95%置信区间[CI]为 0.89 至 1.06；P=0.50）。两组间的胚胎着床率、临床妊娠率、总体妊娠丢失率和持续妊娠率也无显著差异。与新鲜胚胎移植相比，冻融胚胎移植可显著降低卵巢过度刺激综合征的风险（0.6%比 2.0%；相对危险度为 0.32；95%CI 为 0.14 至 0.74；P=0.005）。两组间产科和新生儿并发症及其他不良结局的风险也无显著差异。