One of the most significant events in our lives is the birth of a child. At the same time, on average 20% of couples find difficulties conceiving within the first year of trying. In our society, historically, fertility issues are mostly associated with females' health. However, in 40%-50% of these cases male fertility issues may be at the source of the problem, while, typically, are much easier to treat. The fundamental evaluation of male fertility in the clinical laboratory begins with sperm characterization, where the golden standard is to use a benchtop microscope (manually) and/or a computer-assisted automated semen analysis (CASA) system. Though, partially due to cost and partially due to social stigma associated with clinical evaluation or treatment, male infertility often stays undetected. This has generated a demand for inexpensive in-home sperm evaluation kits. However, there is currently no product on the market that offers in-home and quantitative measurement of sperm count and motility ? parameters vital for interpretation of semen quality. This proposal aims to develop and commercialize a Lucendi Semen Performance Analytics (Lucendi SPA) platform. Lucendi SPA will be a rapid (<2 minutes), simple-to-use, inexpensive, compact, lightweight, and portable product for automated analysis of sperm characteristics ideal for repeated and continual testing of male fertility and wellness. Lucendi SPA will be designed based on a novel lens-free microscopy technology developed over the past decade at UCLA by Prof. Ozcan's lab. Lucendi SPA system will consist of a disposable cartridge (for single use) and a multi-use computational reader. Another component of the Lucendi SPA system will be a mobile/web application that tracks and quantifies user's sperm characteristics and quality over time, provides actionable feedback and easy to understand metrics, offers wellness and lifestyle suggestions for improvement of results and stimulates an overall healthy lifestyle, promoting wellness. With the relatively low cost of computational power, we believe that such a compact, light-weight and cost- effective automated semen analysis platform running on a wide-field lensfree on-chip microscope would be especially useful for in-home male fertility tests. Potential other application areas of this unique semen analysis platform are vast and include post-vasectomy tests either at home or in clinics, sperm analysis in fertility clinics (including IVF procedures), semen quality evaluation in sperm banks, stud performance assessment at animal breeding centers, and stud health monitoring in farms. In addition to these, by using a larger-area image sensor, this platform can also be transformed into a significantly higher throughput analysis platform that can measure sperms' response to different drugs or chemicals of various concentrations in parallel.

Public Health Relevance

Approximately 20% of couples find difficulties conceiving within the first year of trying, and in 40%-50% of these cases male fertility issues may be at the source of the problem. However, partially due to cost and partially due to social stigma associated with clinical evaluation or treatment, male infertility often stays undetected. This proposal aims to develop and commercialize a Semen Performance Analytics (SPA) platform that will be an in-home, rapid (<2 minutes), simple-to-use, inexpensive and field-portable product for automated analysis of sperm characteristics ideal for repeated and continual testing of male fertility and wellness.

Agency
National Institute of Health (NIH)
Institute
Eunice Kennedy Shriver National Institute of Child Health & Human Development (NICHD)
Type
Small Business Innovation Research Grants (SBIR) - Phase II (R44)
Project #
4R44HD093493-02
Application #
9616379
Study Section
Special Emphasis Panel (ZRG1)
Program Officer
Moss, Stuart B
Project Start
2018-08-01
Project End
2020-07-31
Budget Start
2018-08-01
Budget End
2019-07-31
Support Year
2
Fiscal Year
2018
Total Cost
Indirect Cost
Name
Lucendi, Inc.
Department
Type
DUNS #
080369315
City
Los Angeles
State
CA
Country
United States
Zip Code
90077