Development of A Sperm Morphology Standard

精子形态学标准的制定

• 批准号: 6646303
• 负责人: SUSAN A ROTHMANN
• 金额: $ 13.73万
• 依托单位: FERTILITY SOLUTIONS, INC.
• 依托单位国家: 美国
• 财政年份: 2003
• 资助国家: 美国
• 起止时间: 2003-05-14 至 2004-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6646303
• 关键词: Internet; cell morphology; computer assisted instruction; cytodiagnosis; diagnosis design /evaluation; diagnosis quality /standard; digital imaging; fertility; human tissue; male; male reproductive system disorder diagnosis; sperm

DESCRIPTION (provided by applicant): Infertility affects an estimated ten million Americans annually. A critical "gateway" diagnostic test used in over 10,000 USA labs is sperm morphology, one of the most predictive measures of fertility potential that often determines the course of clinical intervention. Morphology also is an important measure of toxic exposure from environmental and occupational sources. Unfortunately, morphology analysis often is the most unreliable and difficult part of a semen profile to interpret, due primarily to lack of a useful Standard. Several schemes exist, none of which have adequate agreement among laboratories. The goal of the proposal is to determine the feasibility of developing a consensus Standard for sperm morphology associated with reproducible visual and morphometric characteristics. A set of sperm images illustrating different typologies will be created with emphasis on the most problematic -- normal and borderline normal forms. Approximately 100 expert andrologists will classify each sperm image and describe the visual characteristics associated with classification. Data will be analyzed to determine the images with the most agreement and disagreement using Cohen's Kappa measure. Correlation of classification will be made with specific visual parameters such as oval shape, smoothness, perceived length to width ratio. The end results of the feasibility study will be: 1) a set of images with good agreement and a set needing more study and clarification (low Kappa); 2) data on agreement that can be used to set sample sizes needed for images and reviewers in the Phase II application; 3) a better understanding of what images are problematic and why; 4) a Phase II application to create a definitive Standard in multimedia formats. The image sets and data would be expanded and developed in a subsequent Phase II application to create a Standard multimedia sperm atlas for training and reference. In Phase II, a Computer Assisted Semen Analyzer (CASA) would be used to rapidly find multiple images for each sperm type. A comprehensive image set based on community consensus will be developed into multimedia teaching and quality control tools. The Standard would be available in print and CD and as an lnternet on-line subscription service for internationally accessible laboratory training and reference.

描述（由申请人提供）：不孕症每年影响大约一千万美国人。在超过10，000个美国实验室中使用的关键“门户”诊断测试是精子形态学，这是生育潜力的最具预测性的指标之一，通常决定临床干预的过程。形态学也是环境和职业来源的毒性暴露的重要量度。不幸的是，形态学分析通常是精液分析中最不可靠和最难解释的部分，主要是由于缺乏有用的标准。有几种方案，其中没有一种在实验室之间达成充分的一致。 该提案的目的是确定制定与可重现的视觉和形态测量特征相关的精子形态共识标准的可行性。将创建一组说明不同类型学的精子图像，重点是最有问题的正常和边缘正常形式。大约有100名男科专家将对每个精子图像进行分类，并描述与分类相关的视觉特征。将使用Cohen的Kappa测量对数据进行分析，以确定最一致和最不一致的图像。分类将与特定的视觉参数（例如椭圆形、平滑度、感知长宽比）进行关联。可行性研究的最终结果将是：1）一组具有良好一致性的图像和一组需要更多研究和澄清的图像（低Kappa值）; 2）可用于设置II期申请中图像和审查员所需样本量的一致性数据; 3）更好地了解哪些图像存在问题及其原因; 4）第二阶段应用程序，以创建多媒体格式的最终标准。 图像集和数据将在随后的第二阶段应用中扩展和开发，以创建标准多媒体精子图谱，供培训和参考。在第二阶段，计算机辅助精液分析仪（CASA）将用于快速找到每种精子类型的多个图像。一个基于社区共识的综合图像集将被开发成多媒体教学和质量控制工具。该标准将以印刷品和光盘的形式提供，并作为国际上可获得的实验室培训和参考资料的因特网在线订阅服务提供。