The FLUSH trial--flushing with lipiodol for unexplained (and endometriosis-related) subfertility by hysterosalpingography: a randomized trial.
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.
Johnson
N P
NP
University of Auckland Department of Obstetrics and Gynaecology, National Women's Hospital, Auckland, New Zealand. n.johnson@auckland.ac.nz
Farquhar
C M
CM
Hadden
W E
WE
Suckling
J
J
Yu
Y
Y
Sadler
L
L
D000328:Adult; D004715:Endometriosis / Q000000981:diagnostic imaging* / Q000188:drug therapy*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007047:Hysterosalpingography; D007247:Infertility, Female / Q000000981:diagnostic imaging* / Q000188:drug therapy*; D007459:Iodized Oil / Q000008:administration & dosage* / Q000627:therapeutic use; D011247:Pregnancy; D011256:Pregnancy Outcome; D018873:Pregnancy Rate; D007507:Therapeutic Irrigation
D007459:Iodized Oil