A RANDOMIZED CONTROLLED TRIAL OF HOME SEMEN TESTING IN MEN BEGINNING ATTEMPTS TO CONCEIVE: INITIAL SEMEN TESTING RESULTS

To determine the feasibility of home semen testing in men beginning attempts to conceive and overall impact of home testing on fertility-related quality of life. We randomized men in early stages of family building (trying to conceive for < 6 months or beginning attempts to conceive in the next 12 months) to either early home semen testing (HST) or standard of care (SOC) without early testing. Men were excluded if they had prior children, did not have a female current partner, or had undergone prior fertility evaluation or treatment. Baseline demographics, WHO-5 well-being index, and fertility quality of life tool (FertiQol) were assessed for both groups. HST was performed using the Yo Sperm® smartphone-based test, and results were sent directly from the patient to the study team to confirm test completion. All men in the HST group completed post-testing questionnaires. After screening of 205 men, 71 men were randomized with 33 in the HST and 41 in the SOC groups. There was no differences in baseline age, race/ethnicity, educational status, income level, self-reported health status, WHO-5, or FertiQol scores (all p > 0.05). Among men in the HST group, 31 (93.9%) confirmed test completion. Of these, 29 (93.5%) reported that HST was easy to perform and 30 (96.8%) reported that they could easily understand and interpret the results. 10 (32.3%) men had HST results lower than the median for a control group of fertile men, whereas 21 (67.7%) had results higher than the median. The majority of men (24, 77.4%) reported that HST helped them to feel confident about their fertility, whereas 11 (35.5%) reported that HST increased their anxiety about their fertility. HST was easy to complete and the results were easily understood in a cohort of men beginning attempts to conceive. Approximately one third of men completing HST had sperm concentration lower than the median for fertile men, and the HST helped to increase confidence and reduce anxiety around fertility.