囊胚细胞计数法评价辅助生殖用医疗器械临床前安全性

Cell Count of Mouse Blastocyst on Pre-clinical Evaluation of Safety of Medical Devices in Assisted Reproductive Technologies

辅助生殖技术(Assisted Reproductive Technologies,ART)用种类繁多的医疗器械应该通过严格的生物试验来检测其安全性。小鼠胚胎试验(Mouse Embryo Assay,MEA)已被认为是最重要和标准化的方法之一,其阈率是1-细胞鼠胚96 h培养后囊胚形成超过80%。囊胚形成率用于胚胎质量控制的不利之处一直受到关注,原因在于其完全依赖于胚胎形态学,而包括分子和遗传信息在内的详细数据明显缺失和不完整。这迫切要求对ART质量控制的更敏感有效的评估方法。该研究通过计算囊胚内细胞总数、内细胞团(ICM)和滋养层(TE)差异细胞数来评估荧光法MEA的可靠性。该方法改进了传统的MEA,为评估胚胎发育能力提供了一个敏感而有力的平台,应建议作为一种标准化的方法,用于ART医疗器械和临床前程序的质量控制予以推广。

Various types of medical devices used in assisted reproductive technologies(ART)should be detected for their safety by strict biological assays.Mouse embryo assay(MEA)has been recognized as one of the most important and standardized methods with the threshold more than 80%of blastocyst formation rate(BR)after 96 h culture of fertilized eggs.The disadvantage using BR for embryonic quality control has been concerned as it is ubiquitously dependent of embryonic morphology and the detailed data including molecular and genetic information is obviously missing and incomplete.This leads to the urgent requirement for more sensitive and efficient assessments for the quality control of ART.This study evaluated the reliability of an immunofluorescent MEA by counting total cell and differential number of the cells in the inner cell mass(ICM)and trophectoderm(TE)in the blastocyst.This method improved the traditional MEA,provided a sensitive and powerful platform to assess embryonic developmental viability and should be suggested as a standard assay to be globally used for the quality control of medical devices and preclinical procedures in ART.