Vaginal Gel to Enhance Lubrication & Sperm Function

DESCRIPTION (provided by applicant): ING Fertility, LLC ("ING") is a woman-owned company that markets and brands products targeted to the demographic sector of couples trying to conceive children. This Phase I SBIR proposal aims to validate proof of concept for a vaginal gel, "Pro~Cept, designed to provide sperm-safe personal lubrication and an optimal environment for post-ejaculatory sperm function, to promote cervical mucus penetration. Pro~Cept is designed for use by the 11 million US couples who are trying to conceive at any given time (6 million infertile and 5 million fertile couples), and encompasses an estimated US market potential of over $300M per year. Pro~Cept's proprietary plant polysaccharide ingredient has been shown in preliminary studies to mitigate oxidative damage of sperm which can lead to their decreased function including ability to fertilize an oocyte. Phase I funding is essential to prove safety and efficacy of Pro~Cept prior to performance of clinical studies required for future commercialization. Successful completion of this project will allow ING to move directly into clinical studies in Phase II to evaluate Pro~Cept's efficacy in promoting sperm function and cervical mucus penetration in vivo. To achieve this goal, ING proposes the following. HYPOTHESIS: A vaginal gel product containing a plant-derived polysaccharide to optimize sperm function can be applied prior to coitus to provide sperm safe (non-toxic) lubrication and create an optimal environment for post-ejaculatory sperm function. OBJECTIVES: To extend testing and development of a vaginal gel product, "Pro~Cepf ', for use by both fertile and infertile couples who are trying to conceive. Phase I studies are proposed by the company to evaluate the following aims: 1. The efficacy of Pro~Cept to protect and/or enhance the function of ejaculated sperm as assessed by in vitro assays of motility, cervical mucus penetration, oxidative stress, and chromatin stability over time; and 2. The reproductive safety of Pro~Cept in studies of sperm transport and in vivo fertilization rates in rabbits. > No product is currently available for trying to conceive couples that can provide sperm safe personal lubrication and an optimal environment for post-ejaculatory sperm function, With Pro~Cept, ING has the opportunity to commercialize a "first of kind" personal, home-use product targeted to a highly motivated end user group with a large unmet and well-perceived need.