Hum. Reprod. Advance Access originally published online on July 22, 2004
Human Reproduction 2004 19(9):2043-2051; doi:10.1093/humrep/deh418
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The FLUSH Trial—Flushing with Lipiodol for Unexplained (and endometriosis-related) Subfertility by Hysterosalpingography: a randomized trial
1 University of Auckland Department of Obstetrics and Gynaecology, National Women's Hospital, Auckland, 2 Fertility Plus, National Women's Hospital, Auckland, 3 University Specialists, Mercy Specialist Centre, Epsom, Auckland and 4 Auckland Radiology Group, 641 Manukau Road, Royal Oak, Auckland, New Zealand
5 To whom correspondence should be addressed at: University of Auckland Department of Obstetrics and Gynaecology, National Women's Hospital, Auckland, New Zealand. Email: n.johnson{at}auckland.ac.nz
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.
Key words: endometriosis/lipiodol/oil soluble contrast media/randomized trial/unexplained infertility
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