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，该项目将使辅助生殖技术（ART）提供商、不孕夫妇和保险公司受益。随着全球不孕症的增加，抗逆转录病毒治疗服务有巨大的潜在市场。然而，目前的试管婴儿技术提供的结果不充分，而且成本高昂，这对少数能够负担得起试管婴儿的不孕夫妇和大多数无法负担这项技术的夫妇都产生了重大影响。通过减少男科医生和胚胎学家的处理时间需求以及减少精子分离的劳动力需求，成功开发出一种一次性、低成本的平台，自动化试管婴儿的所有步骤，预计将大大提高ART诊所的生产力。这将反过来提高抗逆转录病毒技术诊所的效率、能力和盈利能力，同时降低体外受精的总体成本。较低的价格将减轻使用抗逆转录病毒药物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药物的机会。这项技术还有望提高受精率，提高试管受精的成功率。这个小企业创新研究（SBIR）第一阶段项目将开发一个体外受精芯片平台，以满足对成本效益和高度控制的体外受精过程的需求。操作人员技术水平的差异和操作造成的配子损伤导致试管婴儿成功率的显著差异，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芯片工作流程中执行整个试管婴儿过程，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。该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库和一个用于卵子受精的片段。该项目将开发一个单一的用户友好的商业设备，并通过严格的分析和优化时间、流量、孵化和培养基条件，优化牛配子体外受精过程的每个步骤的条件。该装置将在小鼠和牛模型上进行测试，作为人类治疗的先驱，并与传统的体外受精进行比较。如果成功，完全开发的平台系统将满足对简单易用、价格合理、功能强大和高通量精子样品制备的需求，用于医疗和临床应用，从而提高受精率并改善患者预后。该奖项反映了美国国家科学基金会的法定使命，并通过使用基金会的知识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.