ارزيابي اثربخشي و عوارض جانبي كاتتر ويژه تلقيح داخل رحمي اسپرم در زوج هاي نازا، يك كارآزمايي باليني تصادفي

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

مقدمه: تلقيح داخل رحمي اسپرم (IUI) يكي از روش هاي كمك باروري است كه احتمال قرار گرفتن تخمك در معرض اسپرم در رحم و در نتيجه شانس بارداري را افزايش مي دهد. هدف از تحقيق حاضر مقايسه بهره وري كاتتر Masstec (توليد داخل با نمونه وارداتي آن (PMIU) بود تا در صورت بهره وري مشابه، از نمونه توليد داخلي به عنوان جايگزين نمونه وارداتي استفاده گردد. روش بررسي: اين مطالعه يك كارآزمايي باليني شاهددار تصادفي از نوع مطالعه همزمان موازي بود كه در بيمارستان شهيد بهشتي اصفهان بين سالهاي 98-1397 انجام شد. در اين مطالعه از 62 زوج تازا 30 نفر از كاتتر (Masstec)، محصول شركت مهندسي سلامت يار حكيم - ايران و 32 نفر از كاتتر وارداتي (PMIU محصول شركت Ellios BioTek - فرانسه استفاده كردند. پيامدهاي اوليه شامل مشكل در جاگذاري كاتتر، نياز به استفاده از تناكولوم و نياز به ديلاتاسيون سرويكس در زمان انجام IUI بود. پيامدهاي ثانويه شامل وقوع بارداري شيميايي و وقوع بارداري كلينيكي و وقوع سقط بود. دادهها با استفاده از آزمونهاي مجذور كاي، تي و رگرسيون لجستيك مورد تجزيه و تحليل قرار گرفت. نتايج: نتايج آزمون دقيق فيشر اختلاف معني داري را در پيامدهاي اوليه بين دو گروه نشان نداد ( 0/05

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.