A randomized controlled trial of fallopian tube sperm perfusion compared with standard intrauterine insemination for women with non-tubal infertility.

STUDY QUESTION Does fallopian tube sperm perfusion (FSP) result in better pregnancy and live birth rates than standard intrauterine insemination (SIUI) for couples with non-tubal infertility with or without gonadotrophin or clomiphene stimulation? SUMMARY ANSWER There was no evidence of an improvement in live birth rates with FSP compared with SIUI. WHAT IS KNOWN ALREADY Previous randomized controlled trials have suggested improved live birth rates with FSP but these trials were small. A systematic review published in 2004 suggested heterogeneity in results. STUDY DESIGN, SIZE, AND DURATION This pragmatic, multicentre, randomized controlled trial compared SIUI and FSP in 417 women with non-tubal infertility. PARTICIPANTS/MATERIALS, SETTING, METHODS The patients were treated at fertility clinics in New Zealand, Australia and the United Arab Emirates. MAIN RESULTS AND THE ROLE OF CHANCE Four hundred and seventeen women were randomized to SIUI (n = 210) or FSP (n = 207). Data were available for analysis from 198 women in the SIUI group and 198 women in the FSP group. There were 19 women with incomplete data because of cycle cancellation or withdrawals and 2 women who conceived prior to commencing treatment. There were no significant differences in live birth rates between the two groups with 27 (12.9%) in the SIUI group and 21 in the FSP group (10.1%) [Odds Ratio (OR) 1.31 (0.71, 2.39), P = 0.48]. Two ectopic pregnancies were reported in the SIUI group and one was reported in the FSP group. LIMITATIONS, REASONS FOR CAUTION Different ovulation protocols were used in the different clinics. Approximately 10% of the cycles involved donor sperm and ∼5% of the cycles did not complete the assigned intervention. WIDER IMPLICATIONS OF THE FINDINGS There was no evidence of an improvement in live birth rates with FSP compared with SIUI. STUDY FUNDING/COMPETING INTEREST(S) The study was funded in part by the A+ trust of the Auckland District Health Board. No commercial funding was received. TRIAL REGISTRATION NUMBER ANZCTR Number ACTRN12612001303831.