Efficacy and safety evaluation of HyperSperm treatment in human semen samples

Assisted reproductive technologies (ART) rely on the functional integrity of spermatozoa, which can be affected by in vitro handling and preparation procedures. HyperSperm is a novel sperm treatment medium developed to enhance sperm function and improve clinical outcomes. This study aimed to evaluate the efficacy and safety of HyperSperm in human semen samples from patients undergoing fertility treatment. A paired analysis was performed on 135 clinical semen samples, each divided into two equal fractions processed using either standard conditions or the HyperSperm protocol. Sperm motility and kinematic parameters were measured with computer-assisted analysis. Safety assessments included sperm viability at baseline and after 24 hours, DNA fragmentation using a fluorescence-based assay, and acrosomal integrity under spontaneous and progesterone-stimulated conditions. Comparisons between paired samples were analyzed using the Wilcoxon matched-pairs signed-rank test. HyperSperm significantly enhanced sperm kinematic parameters, including curvilinear velocity and amplitude of lateral head displacement, resulting in higher levels of hyperactivated motility. Stratification by semen quality demonstrated that samples with reduced motility showed the greatest functional improvement. HyperSperm did not affect sperm viability or DNA integrity, even after 24 hours of incubation, and preserved acrosomal structure and responsiveness to progesterone. The clinical trial was registered at ClinicalTrials.gov (NCT06742437, December 12th 2024). HyperSperm improves critical sperm functional parameters without compromising cellular viability, DNA stability, or acrosomal integrity. These findings support the safe and effective use of HyperSperm to optimize sperm performance and potentially improve outcomes in assisted reproduction.