Evaluation of the Efficacy and Side Effects of Catheter-Specific Intrauterine Insemination in Infertile Couples, a Randomized Clinical Trial

Introduction: Intrauterine insemination (IUI) is one of the assisted reproductive techniques, which increases the likelihood of egg being exposed to sperm in the uterus and thus the chances of pregnancy. The purpose of the present study was to compare the efficiency of the Masstec catheter (the internal product) with imported catheter (PMIU) so that, if similar, use domestic production as an alternative to imported. Methods: This study was a randomized controlled clinical trial continuous sampling method performed in Shahid Beheshti Hospital in Isfahan between 2016-2017. In this study, out of 62 infertile couples, 30 used catheters (Masstec), produced by Salamat Yar Hakim Engineering Company - Iran, and 32 imported catheters (PMIU), produced by Ellios BioTek – France. Primary outcomes included difficulty in catheter placement, the need to use a tenaculum, and the need for cervical dilatation during IUI. Secondary outcomes included chemical pregnancy, clinical pregnancy, and abortion. The data were analyzed using Chi-square, t-test and logistic regression. Results: Fisher exact test results showed no significant difference in primary outcome between the two groups (P>0.05). Secondary outcomes, including chemical, clinical and abortion rates were not significantly different between the two groups (P>0.05). Efficacy and side effects of Masstec IUI catheter were not different from PMIU catheter. Conclusion: Our study showed that the efficacy and side effects of the Masstec IUI catheter were not different from PMIU catheter. Given the similar efficacy and side effects and lower cost of the IUI catheter produced by the local company than the imported catheter, the use of local catheter is recommended for IUI candidate patients.