Automation of human semen analysis using a novel artificial intelligence optical microscopic technology

Area of Science:

• Reproductive Medicine
• Medical Technology
• Artificial Intelligence in Diagnostics

Background:

• Manual semen analysis is the current standard but is labor-intensive, subjective, and time-consuming.
• Existing computer-assisted semen analyzers (CASAs) have limited adoption due to complex operation.
• There is a critical need for accessible, rapid, and standardized semen analysis methods.

Purpose of the Study:

• To develop and clinically validate a novel automated semen analysis technology.
• To assess the performance of the LensHooke™ X1 PRO (X1 PRO) system for quantitative measurement of sperm parameters and seminal pH.
• To compare the X1 PRO results with established manual microscopy methods.

Main Methods:

• Development of an automated artificial intelligence optical microscopic (AIOM) technology, the X1 PRO.
• Clinical testing involving 135 human semen samples.
• Quantitative measurement of sperm concentration, motility (progressive motility), and seminal pH using the X1 PRO.
• Comparison of X1 PRO results against standard manual microscopy and pH measurement techniques.

Main Results:

• High correlation was observed between X1 PRO and manual methods for sperm concentration and progressive motility.
• Progressively motile sperm concentration also showed a high degree of correlation between the two methods.
• Seminal pH measurements by X1 PRO were comparable to manual methods (p = 0.12).

Conclusions:

• The X1 PRO semen analyzer is a reliable diagnostic tool for routine semen analysis.
• The system provides clinically acceptable results aligned with World Health Organization (WHO) 5th Edition guidelines.
• The novel AIOM technology offers an accessible and rapid alternative for semen analysis.