The FLUSH Trial—Flushing with Lipiodol for Unexplained (and endometriosis-related) Subfertility by Hysterosalpingography: a randomized trial

• Published in: Human reproduction (Oxford) Vol. 19; no. 9; pp. 2043 - 2051
• Main Authors: Johnson, N.P., Farquhar, C.M., Hadden, W.E., Suckling, J., Yu, Y., Sadler, L.
• Format: Journal Article
• Language: English
• Published: Oxford Oxford University Press 01.09.2004; Oxford Publishing Limited (England)
• Subjects: Adult; Biological and medical sciences; Embryology: invertebrates and vertebrates. Teratology; Endometriosis; Endometriosis - diagnostic imaging; Endometriosis - drug therapy; Female; Follow-Up Studies; Fundamental and applied biological sciences. Psychology; Humans; Hysterosalpingography; Infertility, Female - diagnostic imaging; Infertility, Female - drug therapy; Iodized Oil - administration & dosage; Iodized Oil - therapeutic use; lipiodol; oil soluble contrast media; Pregnancy; Pregnancy Outcome; Pregnancy Rate; randomized trial; Therapeutic Irrigation; unexplained infertility; oil soluble contrast media; endometriosis; unexplained infertility; randomized trial; lipiodol; Skin disease; Subfertility; Cardiovascular disease; Endometriosis; Hysterosalpingography; Hot flush; Female genital diseases; Vascular disease; Vertebrata; Mammalia; Uterine diseases; Erythema; endometriosis/lipiodo/oil soluble contrast media/randomized trial/unexplained infertility
• ISSN: 0268-1161; 1460-2350; 1460-2350
• DOI: 10.1093/humrep/deh418

BACKGROUND: To assess the effectiveness of flushing with the oil-soluble contrast medium lipiodol in women with unexplained infertility. METHODS: An open randomized controlled trial design in a single centre secondary and tertiary level infertility service setting. A total of 158 women with unexplained infertility were stratified into two populations: 96 women without confirmed endometriosis and 62 women with endometriosis who had normal Fallopian tubes and ovaries. Randomization was computer-generated, with allocation concealment by opaque sequentially numbered envelopes. Lipiodol flushing was tested versus no intervention. The main outcome measures were clinical pregnancy (assessed at 6 months following randomization) and live birth. RESULTS: Lipiodol flushing resulted in a significant increase in pregnancy [48.0 versus 10.8%, relative risk (RR) 4.44, 95% confidence interval (CI) 1.61–12.21] and live birth (40.0 versus 10.8%, RR 3.70, 95% CI 1.30–10.50) rates versus no intervention for women with endometriosis, although there was no significant difference in pregnancy (33.3 versus 20.8%, RR 1.60, 95% CI 0.81–3.16) or live birth (27.1 versus 14.6%, RR 1.86, 95% CI 0.81–4.25) rates for women with unexplained infertility without confirmed endometriosis. CONCLUSIONS: Lipiodol flushing is an effective treatment for couples with unexplained infertility (based on meta-analysis data), but is particularly effective for women with endometriosis who have normal Fallopian tubes and ovaries.