STTR Phase I: Single-Chip Microfluidic Platform for Finely Controlled In Vitro Fertilization Processes

STTR 第一阶段：用于精细控制体外受精过程的单芯片微流控平台

• 批准号: 2304368
• 负责人: Younas Dadmohammadi
• 金额: $ 27.5万
• 依托单位: ZEALOUS RESEARCH LLC
• 依托单位国家: 美国
• 项目类别: Standard Grant
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-08-15 至 2024-07-31
• 项目状态: 已结题
• 来源: https://www.nsf.gov/awardsearch/showAward?AWD_ID=2304368&HistoricalAwards=false
• 关键词: STTR; Phase; Single; Chip; Microfluidic

The broader impact/commercial potential of this Small Business Innovation Research (SBIR) Phase I project is that by improving the success rate of in vitro fertilization (IVF), this project will benefit assisted reproduction technology (ART) providers, infertile couples, and insurance companies. With infertility increasing globally, there is a huge potential market for ART services. However, current IVF technologies provide inadequate results and come with high costs that significantly impact both the minority of infertile couples who can afford IVF and the majority for whom the technology is priced out of reach. The successful development of a disposable, low-cost platform automating all steps of IVF is expected to produce a manifold increase in the productivity of ART clinics by reducing the processing time demands on andrologists and embryologists as well as reducing the labor requirements for sperm separation. This will, in turn, have the effect of increasing the efficiency, capacity and profitability of ART clinics, while lowering overall costs of IVF. Lower prices will reduce the burden on couples using ART and on their insurance companies, while increasing access to ART for lower-income populations. The technology is also expected to result in higher fertilization rates, enhancing successful IVF conception outcomes.This Small Business Innovation Research (SBIR) Phase I project will develop an IVF-on-a-chip platform in response to the need for a cost-effective and highly controlled IVF process. Variance in operator skill levels and damage to gametes due to handling contribute to significant variability in IVF performance, with success rates averaging only around 37%. The new technology aims to remove this inconsistency by using a microfluidic platform to perform the entire IVF process in a single-chip workflow, automating and optimizing sperm selection, sperm capacitation, and egg fertilization. The proposed platform includes a region for sperm selection, a reservoir for sperm capacitation, and a segment for egg fertilization. This project will develop a single user-friendly commercial device and optimize conditions for each step of the IVF process with bovine gametes, through rigorous analysis and optimization of the timing, flow, incubation, and media conditions. The device will be tested in mice and bovine models as a precursor to human treatment and its performance compared to traditional IVF. If successful, the fully developed platform system will fulfill the need for a simple-to-use, affordable, robust, and high-throughput sperm sample preparation for medical treatments and clinical applications, resulting in higher fertilization rates and enhanced patient outcomes.This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the Foundation's intellectual merit and broader impacts review criteria.

这个小企业创新研究（SBIR）第一阶段项目更广泛的影响/商业潜力是，通过提高体外受精（IVF）的成功率，该项目将使辅助生殖技术（ART）提供商、不孕夫妇和保险受益公司。随着全球不孕不育症的增加，ART服务存在巨大的潜在市场。然而，目前的体外受精技术效果不佳，而且成本高昂，这对少数有能力负担得起体外受精费用的不孕夫妇以及大多数价格昂贵的不孕夫妇产生了重大影响。一次性、低成本平台的成功开发可实现 IVF 所有步骤的自动化，预计将通过减少男科医生和胚胎学家的处理时间需求以及精子分离的劳动力需求，从而大幅提高 ART 诊所的生产力。反过来，这将提高 ART 诊所的效率、容量和盈利能力，同时降低 IVF 的总体成本。较低的价格将减轻使用抗逆转录病毒治疗的夫妇及其保险公司的负担，同时增加低收入人群获得抗逆转录病毒治疗的机会。该技术预计还将带来更高的受精率，从而提高 IVF 受孕的成功率。这个小型企业创新研究 (SBIR) 第一阶段项目将开发一个 IVF-on-a-chip 平台，以满足对具有成本效益的需求。以及高度受控的体外受精过程。操作员技能水平的差异以及操作导致的配子损伤会导致 IVF 性能的显着差异，平均成功率仅为 37% 左右。这项新技术旨在通过使用微流体平台在单芯片工作流程中执行整个 IVF 过程，自动化和优化精子选择、精子获能和卵子受精，从而消除这种不一致性。所提出的平台包括一个用于精子选择的区域、一个用于精子获能的储存器和一个用于卵子受精的部分。该项目将开发一种用户友好的商业设备，并通过对时间、流程、孵化和培养基条件的严格分析和优化，优化牛配子体外受精过程每个步骤的条件。该设备将在小鼠和牛模型中进行测试，作为人类治疗的先驱，并与传统体外受精相比其性能。如果成功，完全开发的平台系统将满足医疗和临床应用对使用简单、价格实惠、稳定和高通量的精子样本制备的需求，从而提高受精率并改善患者的治疗效果。该奖项反映了 NSF 的法定使命，并通过使用基金会的智力价值和更广泛的影响审查标准进行评估，被认为值得支持。