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

这个小企业创新研究（SBIR）第一阶段项目的更广泛的影响/商业潜力是，通过提高体外受精（IVF）的成功率，该项目将有利于辅助生殖技术（ART）提供者，不孕夫妇和保险公司。随着全球不孕症的增加，ART服务有着巨大的潜在市场。然而，目前的试管婴儿技术提供的结果不足，并且成本高，这对能够负担得起试管婴儿的少数不孕夫妇和大多数技术价格无法承受的不孕夫妇都产生了重大影响。一次性、低成本平台的成功开发使IVF的所有步骤自动化，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要求，来提高ART诊所的生产率。这将反过来提高ART诊所的效率，能力和盈利能力，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疗法的夫妇及其保险公司的负担，同时增加低收入人口获得抗逆转录病毒疗法的机会。该技术还有望提高受精率，提高成功的IVF受孕结果。这个小企业创新研究（SBIR）第一阶段项目将开发一个IVF芯片平台，以满足对成本效益和高度控制的IVF过程的需求。操作者技能水平的差异和操作造成的配子损伤导致IVF性能的显著差异，成功率平均仅为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来消除这种不一致性。该平台包括一个精子选择区、一个精子获能池和一个卵子受精区。该项目将开发一种单一的用户友好的商业设备，并通过严格分析和优化时间，流量，孵育和培养基条件，优化牛配子IVF过程的每个步骤的条件。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，并与传统的IVF进行比较。如果成功的话，这个完全开发的平台系统将满足医学治疗和临床应用对简单易用、价格合理、稳定可靠和高通量精子样本制备的需求，从而提高受精率和改善患者预后。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。

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.