Development and validation of a novel mail-in semen analysis system and the correlation between one hour and delayed semen analysis testing.

ABSTRACT

OBJECTIVE: To develop and validate a novel, mail-in semen analysis (SA) system. DESIGN: Prospective cohort. SETTING: Not applicable. PATIENT(S) Ejaculates from normospermic men. INTERVENTION(S) One-hour SA, then repeat SAs (on same ejaculate) over 52 hours using a novel technique for maintaining sperm viability. MAIN OUTCOME MEASURE(S) World Health Organization SA parameters. RESULT(S) One-hour SA on 104 ejaculates in the validation phase of the study demonstrated normal semen parameters. With up to 52 hours of observation and four subsequent SA measurements/ejaculate, concentration remained stable, motility decreased by 0.39%/h, and normal morphology decreased by 0.1%/h. Measured 1-hour and calculated motility (correlation coefficients 0.87) and morphology (correlation coefficients 0.82) strongly were correlated. CONCLUSION: This novel, mail-in, Clinical Laboratory Improvement Amendments-approved SA testing system demonstrates a strong degree of correlation between 1-hour and delayed SA testing. Given the linear motility and morphology decrease and stability of sperm concentration, this test may be used in clinical practice to evaluate semen quality for fertility evaluations. Furthermore, this approach significantly improves the ease, comfort, and efficiency of obtaining a SA, likely breaking down early barriers to accessing successfully a male fertility evaluation.