STTR Phase I: Development of a Novel Microfludics Device to Optimize Sperm Retrieval and Storage from Microsurgical Testicular Sperm Extraction

The broader impact/commercial potential of this project is (1) the significant improvement in fertility rates among infertile couples and especially for patients suffering from non-obstructive azoospermia (NOA), which is found in 1% of the male population and in up to 20% of male infertility cases and is associated with non-measurable levels of sperm in the ejaculate. Automated systems to collect sperm from these samples would greatly reduce costs and failure rates. (2) Second, the proposed devices will be used in the preparation of insemination samples to isolate high quality sperm, or in the removal of white blood cells from a heterogeneous sample to yield sperm samples that are suitable for intrauterine insemination, again leading to higher fertility rates and lower costs for infertile couples. (3) The sperm processing market could be substantial: If approximately 50% of labs in the US used this system, the total cycles per year would be approximately 44,000. At a cost of $250/each, the market for NOA alone would be $11M. The utility in insemination and microTESE come not only in its potential effectiveness to isolate sperm but also in the decreased workload on technicians. The number of inseminations is much higher in the US and would add additional room for market expansion of at least $30M/year. Rates of insemination are much higher in Europe and growing in Asia, suggesting the overall market could readily be more than $100M/year. This Small Business Technology Transfer Research (STTR) Phase I project is about improving current clinical procedures for Microsurgical Testicular Sperm Extraction (mTESE) when used with patients suffering from non-obstructive azoospermia (NOA), which includes a large proportion of infertile men (10% - 20%). For patients suffering with non-obstructive azoospermia (NOA), obtaining sperm presents a great challenge, and thus, the rate of pregnancy for this group of infertile patients remains low. mTESE procedures currently rely on manual microscopic inspection of testicular tissue specimens to identify sperm in a mTESE sample that has very low concentration of sperm cells and a large concentration of other cells and bioparticles. Hence extracting sperm from mTESE samples is a long, inefficient (low sperm recovery) and labor-intensive process. This project involves the development of a microfluidic system that improves sperm recovery rates specifically from NOA patients. The microfluidic system would utilize label-free cell separation technologies to separate sperm from other cells/bioparticles and then sort the separated sperm in groups for cryopreservation. The final outcome of the project would be a system that inputs a mTESE sample and outputs groups of sperm that can be cryopreserved at the group-level.