Harvard researchers develop low-cost, smartphone-based male fertility test

By Heather Mack
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Scientists have developed a method to test for male infertility that doesn't require much more than a smartphone. By building an app and pairing with a custom-made 3D-printed case that can magnify sperm and reveal the number of sperm and their motility, researchers at Harvard Medical School affiliated Brigham and Women’s Hospital and Massachusetts General have devised a cheap, quick and convenient way for any man to perform his own semen analysis.

For under $5, scientists created a disposable, easy-to-use fertility testing system that puts the entire process directly into mens’ hands, which they believe is a valuable asset considering the high worldwide rates of infertility as well as the many barriers that prevent men from pursuing conventional methods of testing. Of the more than 45 million couples worldwide who are affected by infertility, over 40 percent of the cases include some male component.

“Although male infertility is as common as female infertility, it often goes undiagnosed because of socioeconomic factors such as stigma, high cost of testing, and availability of laboratory facilities,” the researchers wrote in the paper published in the journal Science Translational Medicine. “Furthermore, healthcare disparities related to economic, cultural, societal, geographical, and religious factors are major impediments to accessing infertility care worldwide, especially in developing countries, making it one of the most underestimated and neglected health care issues.”

The tool consists of a disposable microchip equipped to handle a semen sample, which is slipped into the smartphone attachment and activates the camera to morph into a microscope. From there, the app guides the user through a video analyzing the sperm cells and their movements. To evaluate the smartphone-based semen analyzer, researchers recruited both trained and untrained study participants using over 350 samples and took the device head-to-head with traditional lab equipment. The smartphone tool was able to identify abnormal sperm samples with 98 percent accuracy. 

“We have demonstrated that the smartphone-based semen analyzer can accurately measure sperm concentration, motility, total sperm count, total motile sperm count, and linear and curvilinear velocities using a small volume of an unwashed, unprocessed semen sample loaded into a disposable microchip,” the researchers write. “We developed an automated smartphone-based diagnostic assay with the potential to make male fertility testing as accessible, easy, fast, and private as pregnancy tests.”

This isn’t the first at-home, app-based semen analysis testing out there, but it’s the first that is both compact and tests for both sperm count and motility. Medical Electronic Systems, which makes commercial-grade automated semen analyzers, launched home-testing kit and companion app called YO, which works with an arsenal of tiny lab equipment including a mini microscope that clips onto a smartphone. Sandstone Diagnostics has an FDA-cleared, app-connected home test for male fertility called Trak, but the actual testing is done via a portable centrifuge. 

The Harvard researchers’ tool isn’t yet a real product in the market, but they believe the low price point, ease of use and comprehensiveness of testing metrics could have a significant impact around the world. Additionally, the tool’s simplicity and disposable nature relieves the need for professional training and repeated quality control exercises that are necessary for the current standard system: manual microscope-based testing and computer assisted semen analysis (CASA).

“Our easy-to-use platform eliminates the need for such exercises and may aid in the standardization of semen tests because variability in semen analysis is still relatively high,” they write. “Furthermore, infertility in resource-limited settings is also a global issue, and the ability to provide routine, point-of-care, low-cost, reliable semen analysis testing is needed. CASA systems are relatively expensive, and even in the United States, many clinics and fertility centers use manual semen analysis methods, resulting in poor standardization. Our system, with its low manufacturing costs can potentially introduce a better standardization of care in regions of the world that require it the most.”