[A quality control for the culture system using endotoxin assays in human in vitro fertilization and embryo transfer].

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.