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

SBIR 第一阶段：经阴道卵巢透热疗法治疗与多囊卵巢综合征相关的不孕症

• 批准号: 1519804
• 负责人: Neil Barman
• 金额: $ 15万
• 依托单位: Ziva Medical, Inc.
• 依托单位国家: 美国
• 项目类别: Standard Grant
• 财政年份: 2015
• 资助国家: 美国
• 起止时间: 2015-07-01 至 2015-12-31
• 项目状态: 已结题
• 来源: https://www.nsf.gov/awardsearch/showAward?AWD_ID=1519804&HistoricalAwards=false
• 关键词: SBIR; Phase; Transvaginal; Ovarian; Diathermy

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).

这个小企业创新研究（SBIR）第一阶段项目的更广泛的影响/商业潜力在于简化多囊卵巢综合征（PCOS）所致不孕症的治疗。PCOS影响六分之一的育龄妇女，并影响自然排卵的能力。最常见的二线治疗是注射激素，6个月的疗程花费15，000 - 20，000美元，每月需要5-6次临床访问以避免严重的副作用。临床指南还推荐一种不常使用的腹腔镜手术，可以使排卵正常化，并导致与激素注射相似的怀孕率。这笔资金将促进与手术相同的组织效果的工作，但通过微创的基于针的访问途径，类似于其他生育程序中常用的方法。这对患者和医生来说是非常有利的，原因如下：成本是激素注射的一半，通过一次性手术实现自然排卵，需要很少的临床访问，并将双胞胎/三胞胎的比率降低到1-2%（相比之下，激素为20-25%），因此怀孕将不那么复杂。在美国，75%的生育费用由患者自付，因此大幅降低成本将使更多的人获得这些治疗。拟议的项目特别寻求资助工作，以描述在超声引导下使用微创针式方法复制手术效果的可行性。这项工作成功的保证是，使用与商业上可接受的器械（基于针的通路、超声可视化、可接受的能量输送时间和功率以及属于生育医生技能范围内的技术）参数一致的器械，受影响的组织体积足够且可预测。