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.
University of Auckland Department of Obstetrics and Gynaecology, National Women's Hospital, Auckland, New Zealand. n.johnson@auckland.ac.nz
N P
NP
Johnson
C M
CM
Farquhar
W E
WE
Hadden
J
J
Suckling
Y
Y
Yu
L
L
Sadler
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