Efficacy and Safety of Polyherbal Formulation in Low Sperm Count Participants: A Randomized, Multicenter, Double-Blinded, Placebo-Controlled, Interventional Study

INTRODUCTION: Male infertility, particularly oligospermia, is characterized by reduced sperm count. It remains a significant clinical concern due to its multifactorial origin and limited therapeutic options. The present study investigates the efficacy and safety of "SHL 1066," a standardized polyherbal formulation, in enhancing semen quality and improving sexual health outcomes in men with low sperm counts. MATERIALS AND METHODS: In a 90-day, multicenter, randomized, double-blinded, placebo-controlled trial, 60 male participants were randomly assigned to receive either "SHL 1066" or a placebo using a computer-generated randomization protocol. Assessments of sperm count, motility, serum total testosterone, and sexual health parameters (erectile function, intercourse satisfaction, and overall satisfaction) were conducted at baseline and study completion. RESULTS: After 90 days, "SHL 1066" significantly increased sperm count by 72.5% and motility by 14.4%, compared to 8.6% and 6.3%, respectively, in the placebo group. Serum total testosterone levels rose by 23.3%. Sexual health outcomes improved markedly, with erectile function enhanced by 45.5%, intercourse satisfaction by 52.8%, and overall satisfaction by 54%, substantially surpassing placebo outcomes. CONCLUSION: "SHL 1066" demonstrated safety, tolerability, and significant efficacy in improving sperm count, motility, testosterone levels, and sexual health compared to placebo. These results position "SHL 1066" as a promising therapeutic option for managing male infertility by enhancing semen quality and sexual function.