Frozen versus fresh single blastocyst transfer in ovulatory women: a multicentre, randomised controlled trial

Frozen versus fresh single blastocyst transfer in ovulatory women: a multicentre, randomised controlled trial
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排卵女性的冷冻与新鲜单囊胚移植:一项多中心、随机对照试验

DOI:
10.1016/s0140-6736(18)32843-5
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发表时间:
2019-03-30
期刊:
影响因子:
168.9
通讯作者:
Chen, Zi-Jiang
Chen, Zi-Jiang
中科院分区:
医学1区
文献类型:
--
作者:
Wei, Daimin;Liu, Jia-Yin;Chen, Zi-Jiang

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背景:选择性单胚胎移植(ESET)已被越来越多地提倡,但由于担心减少移植胚胎数后妊娠率降低,因此鼓励进行多胚胎移植。延长胚胎培养结合选择性冷冻所有胚胎和进行延迟冷冻胚胎移植可提高ESET后的妊娠率。目的探讨选择性冷冻单囊胚移植与新鲜单囊胚移植相比是否能提高单胎存活率。方法采用多中心、非盲法、随机对照的方法在中国的21个学术生育中心进行研究。从2016年8月1日到2017年6月3日,1650名有规律月经周期的女性接受了第一个体外受精周期。符合条件的妇女被随机分配到新鲜或冷冻单囊胚移植组。随机序列是由计算机生成的,区组大小为2、4或6,按研究地点分层。对于那些被指定为冷冻囊胚移植的人,所有的囊胚都进行了冷冻保存,并进行了延迟冷冻解冻的单囊胚移植。主要结果是独生子女出生率。分析采用意向治疗。这项试验在中国临床试验注册中心注册,编号为ChiCTR-I0R-14005405。结果825名妇女被分配到每组并纳入分析。冷冻单囊胚组的单胎活产率高于新鲜单囊胚组(416[50%]比329[40%];相对危险度[RR]1.26,95%可信区间1.14-1.41,P
Background Elective single embryo transfer (eSET) has been increasingly advocated, but concerns about the lower pregnancy rate after reducing the number of embryos transferred have encouraged transfer of multiple embryos. Extended embryo culture combined with electively freezing all embryos and undertaking a deferred frozen embryo transfer might increase pregnancy rate after eSET. We aimed to establish whether elective frozen single blastocyst transfer improved singleton livebirth rate compared with fresh single blastocyst transfer.Methods This multicentre, non-blinded, randomised controlled trial was undertaken in 21 academic fertility centres in China. 1650 women with regular menstrual cycles undergoing their first cycle of in-vitro fertilisation were enrolled from Aug 1,2016, to June 3,2017. Eligible women were randomly assigned to either fresh or frozen single blastocyst transfer. The randomisation sequence was computer generated, with block sizes of two, four, or six, stratified by study site. For those assigned to frozen blastocyst transfer, all blastocysts were cryopreserved and a delayed frozen-thawed single blastocyst transfer was done. The primary outcome was singleton livebirth rate. Analysis was by intention to treat. This trial is registered at the Chinese Clinical Trial Registry, number ChiCTR-I0R-14005405.Findings 825 women were assigned to each group and included in analyses. Frozen single blastocyst transfer resulted in higher rates of singleton livebirth than did fresh single blastocyst transfer (416 [50%] vs 329 [40%]; relative risk [RR]1.26,95% CI 1.14-1.41, p