OBJECTIVE: To compare the results of fallopian tube sperm perfusion (FSP) versus standard intrauterine insemination (IUI) in patients with unexplained infertility undergoing controlled ovarian hyperstimulation (COH). DESIGN: Randomized, prospective, cross-over study. SETTING:Reproductive medicine unit of a university hospital. PATIENT(S): Fifty-six couples with unexplained infertility. INTERVENTION(S): COH was induced by recombinant FSH and monitored by serial transvaginal ultrasound. On the day of hCG administration during the first treatment cycle, patients were randomized to either IUI or FSP. Thereafter, in case no pregnancy was achieved, patients went on being treated with FSP and IUI in alternate cycles. A maximum of four treatment cycles per couple was performed. FSP was performed using a pediatric Foley's catheter inseminating 4 mL of sperm-enriched suspension; a Kremer-Delafontaine catheter delivering 0.5 mL of sperm suspension was used for IUI. MAIN OUTCOME MEASURE(S): Clinical pregnancy rate per cycle. RESULT(S): One hundred twenty-seven cycles (58 FSP, 69 IUI) were performed. The clinical pregnancy rate per cycle was 21.7% for IUI and 8.6% for FSP, respectively. No major adverse effects were recorded for either technique. CONCLUSION(S): After COH, FSP is less effective than IUI in couples with unexplained infertility.
RCT Entities:
OBJECTIVE: To compare the results of fallopian tube sperm perfusion (FSP) versus standard intrauterine insemination (IUI) in patients with unexplained infertility undergoing controlled ovarian hyperstimulation (COH). DESIGN: Randomized, prospective, cross-over study. SETTING: Reproductive medicine unit of a university hospital. PATIENT(S): Fifty-six couples with unexplained infertility. INTERVENTION(S): COH was induced by recombinant FSH and monitored by serial transvaginal ultrasound. On the day of hCG administration during the first treatment cycle, patients were randomized to either IUI or FSP. Thereafter, in case no pregnancy was achieved, patients went on being treated with FSP and IUI in alternate cycles. A maximum of four treatment cycles per couple was performed. FSP was performed using a pediatric Foley's catheter inseminating 4 mL of sperm-enriched suspension; a Kremer-Delafontaine catheter delivering 0.5 mL of sperm suspension was used for IUI. MAIN OUTCOME MEASURE(S): Clinical pregnancy rate per cycle. RESULT(S): One hundred twenty-seven cycles (58 FSP, 69 IUI) were performed. The clinical pregnancy rate per cycle was 21.7% for IUI and 8.6% for FSP, respectively. No major adverse effects were recorded for either technique. CONCLUSION(S): After COH, FSP is less effective than IUI in couples with unexplained infertility.