DEVELOPMENT AND VALIDATION OF A NOVEL MAIL-IN SEMEN ANALYSIS SYSTEM AND THE CORRELATION BETWEEN ONE HOUR AND DELAYED SEMEN ANALYSIS TESTING

Abstract

To compare the results of standard one hour and delayed semen analysis (SA) testing to establish the effectiveness of a novel mail-in SA system. Prospective cohort. Men undergoing SA in the San Francisco Bay Area were recruited for SA testing with social media advertisements. One-hour SA (World Health Organization 5th edition), then repeat SA testing (on the same sample) was performed, at multiple time points over 52 hours utilizing a novel technique for maintaining sperm viability. 164 subjects were recruited with a subset of 26 for the validation portion of the study. One hour SA on 104 ejaculates from these 26 patients demonstrated mean semen volume 2.82 ml (SD±1.08 ml), sperm concentration of 75.0 million/ml (SD±36.6 million/ml), total motility of 59.8% (SD±9.1%), and normal morphology of 11% (SD±2.7%). With up to 52 hours of observation and 4 subsequent SA measurements per ejaculate, sperm concentration was found to remain stable, motility declined by 0.39% per hour, and normal morphology declined by 0.1% per hour (Table 1. Measured 1 hour and calculated motility (correlation coefficient (CC) 0.87) and morphology (CC 0.82) were strongly correlated. The low coefficient of variation within concentration (3.9%), motility (3.0%), and morphology (4.7%) measurements exceeded minimal FDA standards (10.0%) for SA testing. This novel, mail-in, CLIA-approved SA testing system demonstrates a high degree of correlation between 1-hour SA testing and delayed SA testing. This test was highly reproducible with coefficient of variation exceeding current FDA standards for sperm concentration, motility and morphology. This test is particularly applicable given recent needs for social distancing, concerns for rising prevalence of male infertility and possible patient concerns regarding privacy and embarrassment with face-to-face communication with a medical laboratory staff. Reliable home produced, mail-in testing may increase access to SA testing and allow a reproductive specialist to address any identified abnormalities in a timely manner.Table 1Baseline Semen Parameters and Mean Change Per Hour with Repeated Measurements up to 52 Hours from Production (N= 104 ejaculates from 26 subjects)MeanMedianMinMaxMean Change per Hour*95% CI**Volume (ml)2.822.51.56.0N/AN/AConcentration (million sperm/ml)75.074.49.3162.00.05-0.090.19Motility (%)59.8613477-0.39%-0.044%-0.35%Normal Morphology (%)1111518-0.10-0.11%-0.09%*Samples incubated in 5ml sperm media at random moderate temperatures. Semen analysis performed at least 3 times up to 52 hours after production.**Concentration P=0.29; Motility P < 0.0001; Morphology P < 0.0001 Open table in a new tab