SBIR Phase I: Transvaginal Ovarian Diathermy to Treat Infertility Related to Polycystic Ovary Syndrome

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The broader impact/commercial potential of this Small Business Innovation Research (SBIR) Phase I project lies in the ability to simplify treatment of infertility due to PCOS (polycystic ovary syndrome). PCOS affects 1 in 6 women of childbearing age, and it impacts the ability to ovulate naturally. The most common 2nd-line treatment is injectable hormones that cost $15,000-$20,000 for a 6-month course and require 5-6 clinical visits each month to avoid serious side-effects. Clinical guidelines also recommend an infrequently used laparoscopic surgery that normalizes ovulation and leads to a similar pregnancy rate to hormone injections. This funding will foster work enabling the same tissue effects as the surgery but via a minimally-invasive needle-based route of access, similar to what is commonly used in other fertility procedures. This will be significantly advantageous to patients and physicians for the following reasons: costs half as much as hormone injections, enables natural ovulation via a 1-time procedure, requires few clinical visits, and reduces rates of twins/triplets to 1-2% (as compared to 20-25% for hormones) so pregnancies will be less complicated. In the US, 75% of fertility expenses are paid out-of-pocket by patients, so drastically reducing costs will allow greater access to these treatments.The proposed project specifically seeks to fund work to characterize the feasibility of replicating the surgical effects using a minimally-invasive, needle-based approach performed under ultrasound guidance. Metrics for success for this work will be sufficient and predictable volumes of tissue affected using devices with parameters consistent with a commercially acceptable device (needle-based access, ultrasound visualization, acceptable energy delivery times and powers, and techniques falling within the skill-set of fertility physicians).