Assisted reproductive technologies (ART) methods have improved vastly over the last three decades. The development of technologies such as in vitro fertilization (IVF), intracytoplasmic sperm injection (ICSI) and preimplantation genetic screening (PGS) have enabled pregnancy for couples previously incapable of having their own children. However, despite these advancements in reproductive technologies, there have not been significant developments in instrumentation for standardizing semen sample preparation procedures for intrauterine insemination (IUI). Current clinical semen sample preparation procedures are manual, tedious, slow, prone to human error, and likely harmful to sperm due to excessive centrifugation steps. The labor- and equipment-intensive nature of sperm preparation for IUI precludes many non-specialty OB/GYN clinics from offering this service to patients, and generally limits patient access to larger cities with Andrology laboratories. Significant problems that Nanonc will address with the current proposal are: 1) limited access to fertility care (specifically IUI) due to high costs and the need for trained Andrology personnel and specialized facilities, 2) suboptimal sperm preparation results due to extended protocol times and sperm loss during processing, and 3) risks of laboratory errors inherent in multi-step sperm preparation protocols. Nanonc proposes a system (utilizing microfluidics) for sperm sample preparation that will take in raw ejaculate and output a purified sperm population in an IUI syringe in less than 15 minutes. The IUI syringe will be detachable from the rest of the system. During the 15 minutes, the clinician will not need to perform any actions; as the system will run all of the sample processing steps in an automated fashion. Furthermore, the system will have a footprint of a small desktop printer that is portable to be conveniently placed on a bench in clinical setting. A portable system that performs automated isolation of sperm from ejaculate will revolutionize sperm processing and increase access to sperm sample preparation. Additionally the system will decrease cost, time and skill required to process sperm, and potentially improve outcomes for patients with low sperm counts. By increasing the yield and precision of sperm isolation and concentration techniques, our approach has the potential to offer this exact benefit by specifically providing the opportunity for some patients to try less invasive and less expensive procedures.

Public Health Relevance

Current clinical semen sample preparation procedures are manual, tedious, slow, prone to human error, and likely harmful to sperm due to excessive centrifugation steps. The labor- and equipment-intensive nature of sperm preparation for IUI also precludes many non-specialty OB/GYN clinics from offering this service to patients, and generally limits patient access to larger cities with Andrology laboratories. Nanonc proposes a system (utilizing microfluidics) that would help solve these problems related to sperm sample preparation; the system will take in raw ejaculate and output a purified sperm population in an IUI syringe in less than 15 minutes.

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 #
4R44HD095355-02
Application #
9799115
Study Section
Special Emphasis Panel (ZHD1)
Program Officer
Eisenberg, Esther
Project Start
2018-04-20
Project End
2021-07-31
Budget Start
2019-08-05
Budget End
2020-07-31
Support Year
2
Fiscal Year
2019
Total Cost
Indirect Cost
Name
Nanonc, Inc.
Department
Type
DUNS #
808402411
City
Salt Lake City
State
UT
Country
United States
Zip Code
84108