STTR Phase I:Single-Chip Microfluidic Platform for Finely Controlled In Vitro Fertilization Processes

The broader impact/commercial potential of this Small Business Innovation Research (SBIR) Phase I project is that by improving the success rate of in vitro fertilization (IVF), this project will benefit assisted reproduction technology (ART) providers, infertile couples, and insurance companies. With infertility increasing globally, there is a huge potential market for ART services. However, current IVF technologies provide inadequate results and come with high costs that significantly impact both the minority of infertile couples who can afford IVF and the majority for whom the technology is priced out of reach. The successful development of a disposable, low-cost platform automating all steps of IVF is expected to produce a manifold increase in the productivity of ART clinics by reducing the processing time demands on andrologists and embryologists as well as reducing the labor requirements for sperm separation. This will, in turn, have the effect of increasing the efficiency, capacity and profitability of ART clinics, while lowering overall costs of IVF. Lower prices will reduce the burden on couples using ART and on their insurance companies, while increasing access to ART for lower-income populations. The technology is also expected to result in higher fertilization rates, enhancing successful IVF conception outcomes._x000D_ _x000D_ This Small Business Innovation Research (SBIR) Phase I project will develop an IVF-on-a-chip platform in response to the need for a cost-effective and highly controlled IVF process. Variance in operator skill levels and damage to gametes due to handling contribute to significant variability in IVF performance, with success rates averaging only around 37%. The new technology aims to remove this inconsistency by using a microfluidic platform to perform the entire IVF process in a single-chip workflow, automating and optimizing sperm selection, sperm capacitation, and egg fertilization. The proposed platform includes a region for sperm selection, a reservoir for sperm capacitation, and a segment for egg fertilization. This project will develop a single user-friendly commercial device and optimize conditions for each step of the IVF process with bovine gametes, through rigorous analysis and optimization of the timing, flow, incubation, and media conditions. The device will be tested in mice and bovine models as a precursor to human treatment and its performance compared to traditional IVF. If successful, the fully developed platform system will fulfill the need for a simple-to-use, affordable, robust, and high-throughput sperm sample preparation for medical treatments and clinical applications, resulting in higher fertilization rates and enhanced patient outcomes._x000D_ _x000D_ This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the Foundation's intellectual merit and broader impacts review criteria.