It is estimated that more than 45 million couples around the world are grappling with infertility. However, the current standard methods for diagnosing male infertility are still expensive, labor-intensive, and require testing in a clinical setting.
Investigators at Harvard-affiliated Brigham and Women’s Hospital (BWH) and Massachusetts General Hospital (MGH) are looking to help with a novel, home-based diagnostic test that could be used to measure semen quality with a smartphone. The findings by the team indicate that the prototype analyzer was able to identify abnormal semen samples based on sperm concentration and motility criteria with approximately 98 percent accuracy.
“We wanted to come up with a solution to make male infertility testing as simple and affordable as home pregnancy tests,” Hadi Shafiee, a principal investigator in the Division of Engineering in Medicine and Renal Division of Medicine at BWH, said in a statement. “Men have to provide semen samples in these rooms at a hospital, a situation in which they often experience stress, embarrassment, pessimism, and disappointment… This test is low-cost, quantitative, highly accurate, and can analyze a video of an undiluted, unwashed semen sample in less than five seconds.”
The setup consists of an optical attachment that can connect to a smartphone and a disposable device onto which a semen sample is loaded. The test utilizes the advancements in consumer electronics and microfabrication, with a disposable microchip with a capillary tip and a rubber bulb being used for simple, power-free semen sample handling. A smartphone app is used to guide the user through each step of testing, and a miniaturized weight scale wirelessly connects to smartphones to measure total sperm count.
As part of the evaluation process, the research team collected and studied 350 clinical semen specimens at the MGH Fertility Center. And the prototype device was able to detect abnormal semen samples based on WHO thresholds for sperm concentration and motility (sperm concentration less than 15 million sperm/ml and/or sperm motility less than 40 percent) with an accuracy of 98 percent. The team also evaluated how well both trained and untrained users performed the test using the smartphone-based device.
“The ability to bring point-of-care sperm testing to the consumer, or health facilities with limited resources, is a true game-changer,” John Petrozza, a co-author of the study and director of the MGH Fertility Center, said in a statement. “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 really been able to create a product that will benefit a lot of people.”
Shafiee’s team sees many applications for the technology that go beyond at-home male fertility testing — the device could also be used by men who have had a vasectomy. Moreover, the test could also be used by animal breeders to confirm the quality of a sample, as well as for testing blood and saliva samples.
The team plans to perform additional tests and will file for FDA approval.