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

这个小型企业创新研究(SBIR)第一阶段项目的更广泛的影响/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)提供者、不孕夫妇和保险公司受益。随着全球不孕症的增加，艺术服务有着巨大的潜在市场。然而，目前的试管受精技术提供的结果并不充分，而且成本很高，这对能够负担得起试管受精的少数不孕夫妇和大多数负担不起这项技术的夫妇都产生了重大影响。一次性、低成本、自动化试管受精所有步骤的平台的成功开发，预计将通过减少对男科医生和胚胎学家的处理时间要求以及减少精子分离的劳动力需求，极大地提高ART诊所的生产率。这反过来将产生提高抗逆转录病毒治疗诊所的效率、容量和盈利能力的效果，同时降低试管受精的总体成本。较低的价格将减轻使用ART的夫妇及其保险公司的负担，同时增加低收入人群获得ART的机会。这项技术还有望带来更高的受精率，增强成功的试管受精受孕成果。这项小型企业创新研究(SBIR)第一阶段项目将开发一个单芯片试管受精平台，以满足对经济高效和高度受控的试管受精过程的需求。操作员技能水平的差异和处理对配子的损害导致试管受精性能的显著差异，平均成功率仅为37%左右。这项新技术旨在通过使用微流控平台在单个芯片工作流程中执行整个试管受精过程，实现精子选择、精子获能和卵子受精的自动化和优化，从而消除这种不一致。拟议的平台包括一个精子选择区域，一个精子获能储存库，以及一个卵子受精部分。该项目将开发一种用户友好的单一商业设备，并通过对时间、流程、孵化和培养条件的严格分析和优化，优化牛配子试管受精过程的每一步的条件。该设备将在小鼠和牛模型上进行测试，作为人类治疗的先驱，并与传统的试管受精进行比较。如果成功，完全开发的平台系统将满足医疗和临床应用对简单易用、负担得起、坚固和高通量精子样本制备的需求，从而实现更高的受精率和更好的患者结果。该奖项反映了NSF的法定使命，并通过使用基金会的智力优势和更广泛的影响审查标准进行评估，被认为值得支持。

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.