A randomized controlled study of human serum albumin and serum substitute supplement as protein supplements for IVF culture and the effect on live birth rates†
A randomized controlled study of human serum albumin and serum substitute supplement as protein supplements for IVF culture and the effect on live birth rates†
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DOI：
10.1093/humrep/den396
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发表时间：
2009-04-01
影响因子：
6.1
通讯作者：
Madden, James D.
中科院分区：
文献类型：
--
作者：
Meintjes, Marius;Chantilis, Samuel J.;Madden, James D.
据推测，在培养基中添加比人血清白蛋白（HSA）更复杂的蛋白质可能会改善IVF结局。在IVF培养液中添加额外的人源性蛋白质的费用、劳动力和风险是否合理是一个尚未回答的问题。在一项对接受常规IVF或ICSI的夫妇进行的随机对照试验中，528名患者被分配到两个治疗组中的一个。从2 PN阶段直到胚胎移植时，在补充有HSA作为单独蛋白补充剂的培养基中或在补充有HSA+血清替代品补充剂（SSS）的培养基中培养胚胎。监测的临床终点包括植入（共1151个胚胎）和活产率结果表明，在HSA+SSS培养体系中移植的胚胎着床率较高（289/571，50.6%对比254/580，43.8%;差异6.8%，95% CI 1.0-12.7，P = 0.042）和活产率（167/266，62.8%对142/262，54.2%;差异8.6%，95% CI 0.1-17.3，P = 0.043）。补充的胚胎培养基导致植入率和活产率的总体增加。目前还不确定在培养基中使用人源性血液制品以及对超严格质量控制措施的要求是否使这些研究结果适用于一般的IVF实验室。培养液的蛋白富集可以显著提高胚泡植入率，为转移单胚泡而不影响活产率创造机会。
It has been speculated that the addition of proteins more complex than human serum albumin (HSA) to culture media may improve IVF outcomes. Whether the expense, labor and risk of adding additional human-derived protein to IVF media are warranted is a question unanswered.In a randomized controlled trial with couples undergoing routine IVF or ICSI, 528 patients were assigned to one of two treatment groups. Embryos were cultured in either media supplemented with HSA as a solitary protein supplement or in media supplemented with HSA+serum substitute supplement (SSS) from the 2PN stage until the time of embryo transfer. Clinical end-points monitored included implantation (total 1151 embryos) and live birth rates (total 528 patients).The transfer of embryos cultured in HSA+SSS resulted in higher embryo implantation (289/571, 50.6% versus 254/580, 43.8%; difference 6.8% with 95% CI 1.0-12.7, P = 0.042) and live birth rates (167/266, 62.8% versus 142/262, 54.2%; difference 8.6% with 95% CI 0.1-17.3, P = 0.043) when compared with those of women whose embryos were cultured with HSA as the sole protein supplement.SSS added to commercial HSA-supplemented embryo culture media resulted in an overall increase in implantation and live birth rates. It remains uncertain whether the use of human-derived blood products in culture media and the requirement for ultra-rigorous quality control measures make these findings applicable to the average IVF laboratory. Protein enrichment of media may significantly improve the blastocyst implantation rate, creating opportunities to transfer single blastocysts without compromising the live birth rate.The study was registered at clinicaltrials.gov. NCT00708383.