Study of HyperSperm, a New Sperm Capacitation Method, to Assess Safety and Effectiveness in Semen Samples In Vitro

What this Trial Is About

Researchers are evaluating the effectiveness and safety of HyperSperm, a new sperm capacitation method, in a prospective, multicenter in vitro study using 300 semen samples with different characteristics and abnormalities. This observational study aims to compare HyperSperm processing with standard sperm preparation methods over a 12-month period to better understand how this new technique may affect sperm function. Semen samples are grouped based on their sperm characteristics, including normal sperm parameters, abnormal morphology, reduced motility, low concentration, and frozen-thawed samples. Samples processed with HyperSperm will be compared to those treated with traditional preparation techniques. No interventions will be performed on participants themselves since this is a study on semen samples. Participants will provide semen samples collected by masturbation for laboratory analysis. Researchers will assess outcomes such as sperm hyperactivation, vitality, DNA fragmentation, motility, and survival at specific time points up to 20 hours after processing. The study will monitor these measures to evaluate the new capacitation methods impact on sperm quality and safety over the course of the study, which runs until June 2026.

Efficacy and Safety of a New Sperm Capacitation Method