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

这一小型企业创新研究(SBIR)第一阶段项目的更广泛影响/商业潜力在于能够简化PCOS(多囊卵巢综合征)不孕症的治疗。每6名育龄妇女中就有1人患有多囊卵巢综合征，并影响自然排卵能力。最常见的二线治疗是注射激素，6个月的疗程费用为15,000-20,000美元，每月需要5-6次临床就诊，以避免严重的副作用。临床指南还推荐一种不常用的腹腔镜手术，使排卵正常化，并导致与激素注射相似的妊娠率。这笔资金将促进实现与手术相同的组织效果的工作，但通过一种基于针头的微创途径，类似于其他生育程序中常用的途径。这将大大有利于患者和医生，原因如下：成本是激素注射的一半，通过一次程序实现自然排卵，只需很少的临床检查，并将双胞胎/三胞胎的比率降低到1-2%(与激素的20-25%相比)，因此怀孕将不那么复杂。在美国，75%的生育费用是由患者自掏腰包支付的，因此大幅降低成本将使更多人能够获得这些治疗。拟议的项目特别寻求资助一项工作，以确定使用超声引导下的微创针头方法复制手术效果的可行性。这项工作的成功衡量标准将是使用与商业上可接受的设备一致的参数的设备(基于针头的访问、超声可视化、可接受的能量传递时间和功率以及属于生育医生技能集的技术)的足够和可预测的受影响组织体积。

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).