An At-Home Fertility Test – For Men!

Men are responsible for a full fifty percent of infertility cases, but that stat is hardly represented by the dearth of diagnostic tools and tests conveniently available for them. Women, meanwhile, have had any number of at-home tests for fertility and ovulation available to them for years.

This will change in October 2016. The Food and Drug Administration has just given clearance to the first at-home male fertility testing system.

Called Trak, the product is manufactured by Sandstone Diagnostics out of Livermore, California. It allows couples to measure and track sperm count conveniently and privately as they try to conceive. The design uses centrifugal force to isolate and quantify sperm cells using specially designed disposable cartridges. The system includes the Trak Engine and several disposable test kits for repeat testing.

Greg Sommer, Sandstone CEO notes that “Male infertility is a dramatically under-appreciated condition affecting millions of couples every year. Trak is a complete system that not only gives couples the ability to conveniently measure semen quality at home, but also provides digital health tools and population-based data to help men take charge of their reproductive health in a whole new way.”

Today’s standard practice of medical evaluation by clinical semen analysis done in an office setting is generally viewed as an awkward and embarrassing experience for men, which further contributes to low rates of male evaluation and treatment.

Trak is the first device cleared by the FDA that provides semi-quantitative results, classifying sperm counts as “Low”, “Moderate” or “Optimal” based on World Health Organization guidelines and clinical studies that correlate higher sperm counts with faster time to pregnancy. The system pairs with a mobile app that allows men to enter, track and compare their results to population statistics via the cloud-based community of users and clinical databases, and receive personalized feedback on lifestyle and wellness steps that may boost their sperm count.

“This is a game changer for men’s health,” said Michael Eisenberg MD, director of Male Reproductive Medicine & Surgery at Stanford University Medical Center. “Sperm count provides a window into a man’s overall health and it’s very exciting to see a technology that lowers the barrier for men to get tested, see changes and address fertility concerns. I believe with the convenience and availability of in-home testing, we are poised to improve our understanding of male fertility and empower men to better manage their health.”