Semen's parameters after varicocelectomy surgery with mast cell stabilizers treatment in infertile varicocele patients: Randomized clinical trial study

BACKGROUND AND AIMS: Varicocele is one of the most common causes of male infertility in which testicular function is progressively damaged. This study aims to investigate the effect of varicocelectomy and mast cell stabilizers on reducing sperm DNA fragmentation in infertile patients with varicocele. METHODS: In this randomized clinical trial, after obtaining ethical approval and informed consent, infertile patients with varicocele were randomly assigned to three groups: varicocelectomy, 1 mg ketotifen, and varicocelectomy plus with 1 mg ketotifen for 3‐month follow‐up. Semen analysis and estimation of DNA fragmentation index (DFI) were obtained from all people in the studied time periods. RESULTS: In this study, 420 infertile patients with varicocele were included with an average age of 31.6 years. The results showed that sperm morphology, sperm motility, sperm count, and sperm DFI had significant differences after the intervention (p < 0.05). Also, the results of semen analysis for each group showed that there was a significant improvement in sperm morphology, motility, count, and DFI index of infertile people with varicocele after the intervention (p < 0.05). But the difference was statistically higher in the varicocelectomy plus with 1 mg ketotifen group than in the other groups (p < 0.01). CONCLUSION: The evidence and results of this study showed that the use of varicocelectomy plus ketotifen in infertile people with varicocele was more effective in improving Semen parameters than the use of mast cell stabilizers or varicocelectomy alone.