Randomised Trial of Lipiodol Uterine Bathing Effect (LUBE) in Women with Endometriosis-Related Infertility

BACKGROUND: We aimed to assess whether lipiodol alters endometrial gene expression through a uterine bathing effect that might enhance receptivity to embryo implantation. METHODS: An open-label randomised controlled trial design in a single-centre tertiary infertility service. Twelve women with endometriosis (n [Formula: see text] 11) or previous successful lipiodol procedure (n [Formula: see text] 1) were randomised to receive immediate or delayed lipiodol hysterosalpingography, followed by endometrial biopsy. Endometrial samples were assessed for gene expression, using Affymetrix microarrays and validation studies using reverse transcriptase quantitative polymerase chain reaction analysis. Subsequent endometrial gene expression responses to treatment and clinical fertility outcomes were assessed. RESULTS: Eleven of 12 women had successful endometrial sampling procedures. Nine women had successful pregnancies within the 9-month follow-up phase. Following lipiodol bathing we identified 20 down-regulated and 13 up-regulated genes with p [Formula: see text] 0.05 and with magnitude of change [Formula: see text]1.5-fold in at least three of the four women, with osteopontin being the only gene down-regulated in all four women. CONCLUSIONS: This study supports the concept of a uterine bathing effect of lipiodol altering endometrial biology and gene expression. Whether regulation of inflammation and immune response pathways by lipiodol might contribute to an increase in endometrial receptivity to embryo implantation merits further investigation.