Nagata Y, Yoshimitsu K, Shirakawa K
Department of Obstetrics and Gynecology, School of Medicine, Fukuoka University.
Nihon Sanka Fujinka Gakkai Zasshi. 1993 Mar;45(3):220-6.
The purpose of this study is to investigate the effects of endotoxin on human in vitro fertilization and embryo transfers (IVF-ET) and to evaluate a quality control system for a culture medium using endotoxin assays. Before the final water purification (in an ultra-pure water system with a depyrogen filter) of the medium, the sources of water were pre-purified as follows; (I) distillation-->deionization x 2, (II) distillation-->ultra-pure water system or (III) reverse osmosis system. The limulus amebocyte lysate gelation tests (sensitivities of 0.03 and 0.25EU/ml) were used to detect endotoxin in the medium and in pre-purified water (pre-water). No pregnancies occurred in the endotoxin-positive medium (endotoxin > or = 0.03EU/ml). The endotoxin-negative medium resulted in a 33.3% pregnancy rate and 13.4% implantation rate. No statistical differences in the implantation rate were found among these methods of pre-purification (I: 12.5%, II: 13.4% and III: 20.0%). Endotoxin was detected in all the pre-water between 0.25 and 4.0EU/ml. The clinical pregnancy rate (36.6%) and the implantation rate (16.9%) in pre-water of endotoxin < 0.25EU/ml were significantly higher than those (10.5% and 5.5%) in pre-water of endotoxin > or = 0.25EU/ml (p < 0.05). We confirmed that a very low concentration of endotoxin disturbed a human embryo implantation. Endotoxin assays, not only in the media, but also in pre-water before final purification are useful as a quality control for the IVF-ET program.
本研究的目的是调查内毒素对人类体外受精与胚胎移植（IVF-ET）的影响，并使用内毒素检测法评估一种培养基的质量控制系统。在培养基进行最终水净化（在带有除热原过滤器的超纯水系统中）之前，水源按以下方式进行预净化：（I）蒸馏→去离子×2，（II）蒸馏→超纯水系统，或（III）反渗透系统。采用鲎试剂凝胶法检测（灵敏度为0.03和0.25 EU/ml）培养基和预净化水（预水）中的内毒素。内毒素阳性的培养基（内毒素≥0.03 EU/ml）未发生妊娠。内毒素阴性的培养基妊娠率为33.3%，着床率为13.4%。这些预净化方法（I：12.5%，II：13.4%，III：20.0%）之间的着床率无统计学差异。在所有预水中均检测到内毒素，浓度在0.25至4.0 EU/ml之间。内毒素＜0.25 EU/ml的预水中临床妊娠率（36.6%）和着床率（16.9%）显著高于内毒素≥0.25 EU/ml的预水中的妊娠率（10.5%）和着床率（5.5%）（p＜0.05）。我们证实极低浓度的内毒素会干扰人类胚胎着床。内毒素检测不仅对培养基有用，对最终净化前的预水进行检测也有助于IVF-ET项目的质量控制。
