PFI-TT: A new test for male fertility based on sperm neck structures

这一创新-技术转化伙伴关系(PFI-TT)项目的更广泛影响/商业潜力是开发一种男性生育测试，该测试可以有力地在现有技术无法解释的病例中确定以前无法诊断的不孕原因。目前识别男性因素不育的标准方法是精液分析，但原因不明的男性不育的高发生率表明，精液分析不足以诊断男性不育的原因。这项新技术有望为不孕不育的人类患者提供信息，帮助他们成为父母。此外，使用这项新技术应该有助于降低养牛户的人工授精成本，因为牛精子的商业供应商将有另一种方法来测试精子质量，然后再将其用于田间。此外，通过诊断性测试，有可能开发出直接提高精子质量的治疗方法，而不需要使用辅助生殖技术。这项拟议的项目建立在最近的研究基础上，该研究表明，评估名为中心粒的精子颈结构可以有力地识别男性不育。该PFI项目旨在将这一评估技术转化为具有成本效益的原型。拟议研究的主要目标如下：(I)开发一种试剂盒，通过缩短染色程序来简化测试，产生直接标记其目标的抗体，并找到一种利用更具成本效益的荧光显微镜模型的方法。(Ii)生成用于分析精子中心粒图像的自动化软件，该软件将显示与不育症有关的中心粒质量差。商业化的途径包括完成专利申请并将技术授权给现有公司。这一裁决反映了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 Partnerships for Innovation - Technology Translation (PFI-TT) project is developing a male fertility test that could robustly identify a previously undiagnosable cause of infertility in unexplainable cases with current technology. The current standard method for identifying male-factor infertility is a semen analysis, but the high incidence of unexplained male infertility suggests that semen analysis is insufficient for diagnosing causes of male infertility. This new technology is expected to provide infertile human patients with information to help them achieve parenthood. Additionally, using the new technology should help reduce artificial insemination costs for cattle farmers because the commercial suppliers of cattle sperm will have another method of testing sperm quality before it is used in the field. Furthermore, with a diagnostic test, it would be possible to develop treatments to directly improve sperm quality without using assisted reproductive technology. The proposed project builds upon recent studies demonstrating that assessing a sperm neck structure, called the centriole, could robustly identify male infertility. This PFI project is aimed at translating this assessment technology into a cost-effective prototype. The main goals of the proposed research are as follows: (I) To develop a kit and simplify testing by shortening the staining procedure, generate antibodies that label their targets directly, and find a way to utilize a more cost-effective model of fluorescent microscopy. (II) To generate automated software for analyzing sperm centriole images that would indicate the poor centriole quality associated with infertility. The pathway to commercialization includes completing the patent application and licensing the technology to an existing company.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.