Consumers are increasingly interested in knowing more about their own health. One of the most familiar direct to-consumer diagnostic tests has been the home pregnancy test. We report a practical approach towards developing a new point-of-care diagnostic test for another reproductive health needthe assessment of male fertility. Traditionally, men are less likely to seek medical attention for fertility concerns than their female partners (although millennial males are more interested in fertility testing). A delay in diagnosis of male factor infertility may prolong the infertility treatment process for the couple and result in unnecessary interventions for the female partner. Manual microscopic testing and computer-assisted semen analysis (CASA) technology are expensive and require significant technical skill to use. The idea of an at-home, affordable testing platform to screen for an abnormal semen analysis would obviate the need for a clinic visit and provide preliminary data to guide referrals. Our prototype device has been extensively tested with clinical semen samples. The preliminary results presented are robust and unbiased and patient results are based on blind evaluation of the technology by comparing our microchip results with standard methods. In this Fast Track SBIR project we will further optimize the design parameters and develop a best in class, cellphone-based semen analysis device that could be marketed to a) for home based testing and b) as an inexpensive alternative to CASA in IVF clinics.
Public Health Relevance Statement: PROJECT NARRATIVE The semen analysis is the cornerstone for the diagnosis of male infertility. Manual microscopic testing and computer-assisted semen analysis technology are expensive and require significant technical skill to use. The idea of an at-home, affordable testing platform to screen for an abnormal semen analysis would obviate the need for a clinic visit and provide preliminary data to guide referrals. A simple, rapid, inexpensive, home-based semen analysis test can shift the paradigm in male infertility diagnosis and management in both developed and developing countries.
NIH Spending Category: Bioengineering; Clinical Research; Contraception/Reproduction; Infertility; Machine Learning and Artificial Intelligence
Project Terms: American; base; Biological Assay; blind; Capital; cell motility; Cellular Phone; Clinic; Clinic Visits; Clinical; Computer Assisted; convolutional neural network; cost; Custom; Data; design; Detection; Developed Countries; Developing Countries; Development; Devices; Diagnosis; Diagnostic tests; Evaluation; Feedback; Female; Fertility; Focus Groups; Freezing; Funding; Galaxy; General Hospitals; Gold; Grant; Health; Home environment; Image; Infertility; infertility treatment; interest; Intervention; Laboratories; Laboratory Personnel; male; male fertility; Male Infertility; Manuals; Massachusetts; medical attention; meetings; men; Methods; microchip; Microscopic; Modeling; Monitor; Needs Assessment; neural network architecture; Optics; Patients; Phase; point-of-care diagnostics; Predictive Value; Pregnancy Tests; Preparation; Process; prototype; Reporting; Reproducibility; Reproductive Health; Sampling; Seminal fluid; Sensitivity and Specificity; Slide; Small Business Innovation Research Grant; smartphone Application; Specificity; sperm analysis; sperm cell; sperm morphology; Stains; System; Technical Expertise; Technology; Testing; testing services; Untrained Personnel; Validation
