“Game-changing” Smartphone-based Analyzer Screens for Male Infertility

Researchers at Brigham and Women’s Hospital (BWH) and Massachusetts General Hospital (MGH) have developed a home-based diagnostic test that can be used to measure semen quality using a smartphone-based device. The analyzer can identify abnormal semen samples based on sperm concentration and motility criteria with approximately 98 percent accuracy. These findings were published online on March 22, 2017 in Science Translational Medicine.  

“This test analyzes a video of an undiluted, unwashed semen sample in less than five seconds. It’s low-cost, quantitative, and highly accurate,” says Hadi Shafiee, PhD, a principal investigator in the Division of Engineering in Medicine and Renal Division of Medicine at BWH.

A technician operating the smartphone-based semen analyzer to test a semen sample for male infertility. The system can process most semen samples in under five seconds.

The analyzer consists of an optical attachment that connects to a smartphone and a disposable device onto which a semen sample can be loaded. A disposable microchip with a capillary tip and a rubber bulb is used for simple semen sample handling. The team also designed a smartphone application that guides the user through each step of testing, and a miniaturized weight scale that wirelessly connects to smartphones to measure total sperm count.

To evaluate the device, the research team collected and studied 350 clinical semen specimens at the MGH Fertility Center. The smartphone-based device detected abnormal semen samples based on WHO thresholds on sperm concentration and motility (sperm concentration < 15 million sperm/ml and/or sperm motility < 40%) with an accuracy of 98 percent.

“The ability to bring point-of-care sperm testing to the consumer, or health facilities with limited resources, is a true game changer,” said John Petrozza, MD, a co-author of the study and director of the MGH Fertility Center. “More than 40 percent of infertile couples have difficulty conceiving due to sperm abnormalities and this development will provide faster and improved access to fertility care. By working with Dr. Shafiee and his lab at BWH, and utilizing our clinical fertility expertise here at MGH, we have been able to create a product that will benefit a lot of people.”

Dr. Shafiee’s team, which focuses on developing new technologies using microfluidics, sees many applications for the technology. In addition to at-home male fertility testing for couples trying to conceive, the device could also be used by men who have had a vasectomy. The test could also be used by animal breeders to confirm the virility of a sample. Beyond semen analysis, the device is also compatible with testing blood and saliva samples. He looks forward to exploring these applications soon.

The smartphone-based analyzer for semen analysis is currently in a prototyping stage. The team plans to perform additional tests and will file for FDA approval.

Prospective study to use smartphone-based analyzer to examine the role of environment chemicals on male fertility

Martin Kathrins, MD, in collaboration with Jorge Chavarro and Jaime Hart at the Harvard School of Public Health, submitted a R01 grant proposal this year with the aim of using this smartphone-based semen analyzer to study the effects of endocrine disrupting chemicals on male fertility in a nationwide cohort of young men.

“Using this home-based diagnostic test, we wouldn’t have to invite men to a lab to obtain samples. We can ship the test to study participants across the US, and they will be able to generate data on sperm count, sperm motility, and total sperm count in the privacy of their own homes. We can then quickly and easily analyze large amounts of data remotely to assess whether environmental chemicals or ambient pollutants have detrimental effects on these sperm paraments,” says Dr. Kathrins.

Dr. Kathrins adds that this point-of-care sperm test has the potential to revolutionize male reproductive medicine, as it allows researchers to follow participants in their homes, thereby overcoming the significant hurdle of compliance.

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