Infertility affects as much as 15% of the general population. When a couple has spent a significant amount of time trying to conceive, the disappointment of another month without a positive result can be devastating. Consulting doctors and specialists can help to isolate the cause of the infertility, which can result from a wide range of issues. It is often incorrectly assumed that the difficult lies with the woman, a mistake that is easy to make given her highly visible role in pregnancy. In just over a third of infertility cases, however, the problem in conceiving lies with the man. If his semen are abnormal or low in number, there are blockages that prevent the sperm from traveling to the egg, or the sperm have low motility, meaning they are unable to move themselves in order to reach the egg, the result can be months or years of no results.

In order to understand if the number of sperm present is sufficient, one of the first things that a fertility specialist will want to do is a sperm count. The process for undertaking the count is not complex, but there are other barriers that prevent men from being evaluated in this manner, some of which are related to access and others which are more closely related to social stigma and personal feelings of shame or embarrassment. As a result, a team of researchers from Brigham and Women’s Hospital (BWH) and Massachusetts General Hospital (MGH) decided to pursue the idea of creating an at home diagnostic for men that would analyze semen and indicate whether the count was abnormal. As Dr. Hadi Shafiee, of the Division of Engineering in Medicine and Renal Division of Medicine at BWH, explained:

“We wanted to come up with a solution to make male infertility testing as simple and affordable as home pregnancy tests. Men have to provide semen samples in these rooms at a hospital, a situation in which they often experience stress, embarrassment, pessimism and disappointment. Current clinical tests are lab-based, time-consuming and subjective. 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 device itself is a 3D printed setup that costs less than $5, using a disposable microchip and a rubber bulb for sampling used in connection with an app designed to walk the user through each step of the testing process. While the device is currently still in the testing and prototyping stage, it is showing a great deal of promise with accuracy rates as high as 98%. In addition, the researchers found that it had high rates of accuracy even when used by those who were not trained, something very important for a home test. After all, it might be incredibly simple for an auto mechanic to adjust a lug nut in their own home, but that doesn’t mean I should be let loose with an ‘at-home lug nut tightening’ kit and be expected to perform up to par.

The results of the research, undertaken on 350 clinical semen specimens from the MGH fertility center, has been published in the March 22 issue of Science Translational Medicine. ‘An automated smartphone-based diagnostic assay for point-of-care semen analysis‘ was authored by Manoj Kumar Kanakasabapathy, Magesh Sadasivam, Anupriya Singh, Collin Preston, Prudhvi Thirumalaraju, Maanasa Venkataraman, Charles L. Bormann, Mohamed Shehata Draz, John C. Petrozza and Hadi Shafiee.

As co-author of the study and Director of MGH’s Fertility Center Dr. John Petrozza stated:

“The ability to bring point-of-care sperm testing to the consumer, or health facilities with limited resources, is a true game changer. 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.”

The research team can also imagine other applications for this 3D printed home fertility test, such as in determining the virility of a particular stud in an animal breeding operation or allowing for at-home monitoring for patients after a vasectomy. Even simply as it is, the device helps men regain some sense of dignity and control over a situation that can be not only frustrating but often perceived as personally shameful. In the same way that the home pregnancy test has given women a greater freedom and enabled them to gain knowledge about their situation without the need for invasive or socially charged assistance, men can now potentially benefit from telling tests in the privacy of their own homes.

The reliance on 3D printing to create these devices helps keep the cost low and truly make them accessible in a very practical way. The ability to create these tests on demand in areas where access to medicine might be restricted means that there are no transportation costs or storage needs, thereby creating a much wider set of beneficiaries to their development as 3D printing and smartphones come together in another diagnostic application. All the healthcare in the world doesn’t do any good if there is no access and this is yet another way in which 3D printing has contributed to opening up access and advancing human health. Discuss in the Infertility forum at 3DPB.com.

[Source: BWH]

 

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