: Prospective observation test to evaluate the accuracy of the sperm count and activity measurement of the sperm semen analysis device (sperm tester OVIEW-M PRO).

The OVIEW-M is a self-testing device that can measure the number and activity of sperm using an optical camera on the front side of an individual’s smartphone. We developed OVIEW-M PRO, a semen inspection device using a smartphone application, and conducted a performance verification test to evaluate the accuracy of sperm count and sperm activity. Multinational healthy adult males aged 19 years or older at Hanyang University Hospital in Seoul were targeted, and 46 subjects were conducted through recruitment notification. Those who assessed within 5 days from the day of examination were excluded. In addition, those with azoospermia and spermatosis due to congenital and genetic diseases were excluded. One semen collection sample was divided and the number and activity of sperm were compared with OVIEW-M PRO and the existing method of analysis using a microscope (Olympus BX 53). The mobile phone used in the clinical trial was an Android phone. (Galaxy Note 20) and iPhone 12. The intraclass correlation coefficient (ICC) method was used to check whether there was a difference between the number and motility of sperm in the control group and the number and motility of sperm in the test group, using OVIEW M PRO. This was to check how much difference there is between the control groups, and compare the results with the results obtained through the analysis method through a microscope, which is the existing method, through the Bland & Altman method . The reliability of the test was conducted to confirm the progress of the 95% reliability section. Forty-six patients from 26 countries were included, including 26 yellow, 17 white and 3 black. Mean age was 32.33±6.935 (22-51). The intraclass correlation coefficient of sperm count between iPhone and android was 0.96 (95% CI 0.93-0.98), and the intraclass correlation coefficient of sperm motility was 0.87 (95% CI 0.76-0.93) for iphone and 0.88 (95% CI 0.79-0.93) for android. 0.93). In Bland-Altman plot, sperm count and sperm motility using iphone and android showed high agreement when compared to microscope.