Non-invasive embryo evaluation and selection using time-lapse monitoring: Results of a randomized controlled study
Non-invasive embryo evaluation and selection using time-lapse monitoring: Results of a randomized controlled study
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DOI：
10.1016/j.ejogrb.2018.12.011
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发表时间：
2019-02-01
影响因子：
2.6
通讯作者：
Pribenszky, Csaba
中科院分区：
文献类型：
--
作者：
Kovacs, Peter;Matyas, Szabolcs;Pribenszky, Csaba
目的：与标准的每日评估相比，通过延时（TL）连续监测胚胎提供了更多关于胚胎动力学和形态学的信息。利用TL进行胚胎选择可以支持单胚移植。SET可避免多胎妊娠，改善围产期结局。我们的主要目标是确定与仅基于形态学的胚胎选择相比，基于包括通过连续TL监测评估的动力学和形态学评分的算法选择单个囊胚是否导致上级临床结果。第二个目标是评估是否基于动力学和形态学参数的时间推移评分预测implantation.Study设计：在匈牙利的两个私人IVF中心进行随机对照试验。计划接受第1或第2个IVF周期的不孕夫妇入选。女性年龄必须在36岁以下。干预是基于TL算法的胚胎评估/选择。患者被随机分配至带TL监测的SET（TL-eSET）与带标准评价的SET（对照-eSET）。假设妊娠率从44%增加至58%，基于中期分析以10%的信息分数计算每组202例的样本量。研究的主要结果是妊娠率。次要结局为流产率、活产率、围产期结局和基于动力学和形态学参数构建的时间推移评分预测着床的能力。分类变量的分析采用卡方检验、似然比检验和精确检验。连续变量采用独立组t检验和方差分析进行比较。最终，161例患者被随机分组并进行分析（N = 80例TL-eSET和N = 81例对照-eSET）。两组间的妊娠率无显著差异，但存在有利于TL选择的趋势（TL-eSET：46.3% vs对照-eSET：34.6%，p = 0.150; OR：1.628（95% CI：0.857-3.092））。基于形态学和动力学参数的时间推移评分，植入的囊胚显著高于未植入的囊胚（14.5 +/- 1.8 vs. 12.1 +/- 2.9，p = 0.0001）。有没有不良影响的intervention.Conclusions：选择一个单一的囊胚的基础上，来自延时监测的信息，可以帮助胚胎选择SET。(C)2018爱思唯尔B. V.保留所有权利。
Objective: Continuous monitoring of embryos via time-lapse (TL) provides more information on embryo kinetics and morphology compared to standard daily evaluation. Embryo selection by TL could support single embryo transfer (SET). With SET multiple gestations are avoided and perinatal outcome is improved. Our primary goal was to determine whether selection of a single blastocyst based on an algorithm comprising kinetic and morphologic scores assessed through continuous TL monitoring results in superior clinical outcome compared to embryo selection based on morphology alone. A secondary goal was to assess whether a time-lapse score based on kinetic and morphologic parameters was predictive of implantation.Study design: Randomized controlled trial performed in two private IVF centers in Hungary. Infertile couples scheduled to undergo 1st or 2nd IVF cycles were enrolled. Female age had to be under 36 years. The intervention was embryo evaluation/selection based on TL algorithm. Patients were randomized to SET with TL monitoring (TL-eSET) vs. SET with standard evaluation (control-eSET). Assuming an increase in pregnancy from 44% to 58%, a sample size of 202 per group was calculated based on the interim analysis at 10% information fraction. The primary outcome of the study was pregnancy rate. Secondary outcomes were miscarriage rates, live birth, perinatal outcome and the ability of a time-lapse score constructed based on kinetic and morphologic parameters to predict implantation.Chi-square tests, likelihood-ratio tests and exact tests were used for the analysis of categorical variables. Continuous variables were compared using independent group t-test and analysis of variance.Results: The study was closed after three years. Eventually 161 patients were randomized and analyzed (N = 80 TL-eSET and N = 81 control-eSET). Pregnancy rate did not significantly differ between the groups though there was a trend favoring TL selection (TL-eSET: 46.3% vs control-eSET: 34.6%, p = 0.150; OR: 1.628 (95% CI: 0.857-3.092)). The time-lapse score based on morphologic and kinetic parameters was significantly higher for blastocysts that implanted vs. those that did not (14.5 +/- 1.8 vs. 12.1 +/- 2.9, p = 0.0001). There were no adverse effects of the intervention.Conclusions: Selection of a single blastocyst based on information derived from time-lapse monitoring can aid embryo selection for SET. (C) 2018 Elsevier B.V. All rights reserved.