A prospective randomized controlled trial comparing two embryo transfer catheters in an ART program.

OBJECTIVE: To compare the performance of the Cook Sydney IVF (SIVF) embryo transfer (ET) catheter and the Edwards-Wallace (EW) ET catheter. DESIGN: Prospective randomized controlled clinical trial with an intention-to-treat analysis. SETTING: Two-center study. PATIENT(S): Four hundred consecutive women <40 years undergoing ET with two fresh embryos. INTERVENTION(S): Women were randomly allocated to undergo ET with either the EW or the SIVF catheter, with possible catheter change in case of insertion difficulties. MAIN OUTCOME MEASURE(S): Live birth and clinical pregnancy rates. RESULT(S): Two hundred two women were allocated to the SIVF catheter and 198 to the EW catheter. No significant differences in the clinical pregnancy rates (odds ratio [OR] 0.99, 95% confidence interval [CI] 0.66-1.47) and live-birth rates (OR 1.09, 95% CI 0.72-1.65) were found. The EW catheter had to be changed more often than the SIVF catheter (OR 9.5, 95% CI 3.3-27.5) because of catheter insertion problems. CONCLUSION(S): The pregnancy and live birth rates were not significantly different with the two catheters, but catheter insertion failure was significantly more common with the EW catheter than with the SIVF catheter.