Setting standards for the levels of endotoxin in the embryo culture media of human in vitro fertilization and embryo transfer.

OBJECTIVE

To clarify the optimum set standards for the levels of endotoxin in a culture medium for human IVF-ET programs.

DESIGN

Retrospective and randomized study.

SETTING

One hundred patients underwent 163 cycles of IVF-ET at Fukuoka University Hospital.

INTERVENTIONS

Measurements for endotoxin were performed using the Limulus Amoebocyte Lysate test. The negative group was administered media with < 1 pg/mL of endotoxin and the positive group was given media with > or = 1 pg/mL of endotoxin.

MAIN OUTCOME MEASURES

Human embryo development, clinical outcomes, and pregnancy outcomes were evaluated in each group and also the levels of endotoxin.

RESULTS

The rates of clinical pregnancy (26.1%) and the live birth rates (20.7%) in the negative media were significantly higher than those in the positive media (9.9% and 5.6%, respectively). Rates of embryo development were decreased and a gestational sac and fetal heart beat were not detected in media with > 2 pg/mL of endotoxin.

CONCLUSION

The set standard for the level of endotoxin in a medium should be < 1 pg/mL to obtain the best outcome. The allowable levels of endotoxin in a medium should be < or = 2 pg/mL in human IVF.