A prospective observational test that evaluates the number and activity of sperm using a sperm semen analysis device (sperm tester OVIEW-M PRO), and compares the accuracy with a hospital sperm microscopy.
- Conditions
- Factors influencing health status and contact with health services
- Registration Number
- KCT0005675
- Lead Sponsor
- Intin
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Male
- Target Recruitment
- 46
1) Healthy adult male over the age of 19
2) Those who read, understand, and can agree to the consent form
3) Those who have not assessed within 5 days of the test day
1) Those who assessed within 5 days of the test day
2) Those who have amorphous sperm and sperm deformity due to congenital genetic disease
3) If it is determined that it is not suitable for participation in the research by the judgment of other researchers
Study & Design
- Study Type
- Observational Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method umber of sperm: Number of sperm per mL, Active: Number of sperm with confirmed movement per 100 sperm
- Secondary Outcome Measures
Name Time Method ot applicable