Variability of Semen Parameters with Time in Placebo Treated Men

Purpose: We describe the variability of semen parameters with time in normal men receiving placebo. We also report the impact of season and geographic region, among other variables, on these parameters. Materials and Methods: Data from the placebo arms of 5 randomized, controlled trials were pooled. All trials set minimum standards for semen parameters as an eligibility criterion for entry. Semen parameters examined include volume, density, motility, total count, total motile count and morphology. Mixed model repeated measure analysis was used for statistical analysis. Coefficients of variation for each semen parameter and the percent change from baseline were calculated. Results: The mean within-subject coefficient of variation for each semen parameter ranged from a low of 10% to a high of almost 50%. The contribution of season and region to variability was negligible. The reduction in variability with an increasing number of samples per time point had decreasing returns beyond 2 samples. Conclusions: There was considerable variation in semen parameters with time in subjects who received placebo. Variation could not be attributed to season or region. We observed a general negative trend in semen parameters in this population selected for normal baseline semen parameters, which was likely due to the placebo response or to regression toward the mean.