A randomized controlled trial of tubal flushing with lipiodol for unexplained infertility

Objective: To test the hypothesis that, in couples with unexplained infertility, tubal flushing with an oil-soluble media (lipiodol) would increase the pregnancy rate within 6 months compared with expectant management. Design: A prospective, randomized, controlled study in which couples were allocated to either a single treatment with lipiodol or no further action. Setting: Two tertiary referral centers for assisted reproduction. Patient(s): Couples with a diagnosis of primary or secondary unexplained infertility based on a normal semen analysis according to World Health Organization criteria, patent fallopian tubes at hysterosalpingography or laparoscopy, and ovulatory menstrual cycles based on midluteal phase progesterone levels or ultrasonic follicle tracking. Intervention(s): In those patients randomized to lipiodol, a single treatment was performed. Main Outcome Measure(s): Biochemical (i.e., positive pregnancy test) and clinical (i.e., fetal heart on ultrasound scan) pregnancy rates. Result(s): Seventeen couples were randomized to lipiodol and 17 to expectant treatment. The higher pregnancy rate after lipiodol was statistically significant. There were no complications after lipiodol treatment. Conclusion(s): There was a statistically significantly higher pregnancy rate in couples with unexplained infertility randomized to a single tubal flush with lipiodol compared with no treatment. (Fertil Steril(R) 2002; 77:173-5. (C) 2002 by American Society for Reproductive Medicine).