Sandstone Diagnostics, Inc., Pleasanton, CA, USA.
Department of Epidemiology, Boston University School of Public Health, Boston, MA, USA.
Paediatr Perinat Epidemiol. 2020 Sep;34(5):504-512. doi: 10.1111/ppe.12612. Epub 2019 Dec 15.
Semen quality assessment in population-based epidemiologic studies presents logistical and financial challenges due to reliance on centralised laboratory semen analysis. The Trak Male Fertility Testing System is an FDA-cleared and validated at-home test for sperm concentration and semen volume, with a research use only sperm motility test. Here we evaluate the Trak System's overall utility among men participating in Pregnancy Study Online (PRESTO), a web-based study of North American couples planning pregnancy.
US male participants aged ≥21 years with ≤6 months of pregnancy attempt time at study enrolment were invited to participate in the semen testing substudy after completing their baseline questionnaire. Consenting participants received a Trak Engine (battery-powered centrifuge) and two test kits. Participants shared their test results via smartphone images uploaded to online questionnaires. Data were then linked with covariate data from the baseline questionnaire.
Of the 688 men invited to participate, 373 (54%) provided consent and 271 (73%) completed at least one semen test result. The distributions of semen volume, sperm concentration, motile sperm concentration, total sperm count, and total motile sperm count were similar to 2010 World Health Organization (WHO) semen parameter data of men in the general population. The overall usability score for the Trak System was 1.4 on a 5-point Likert scale (1 = Very Easy, 5 = Difficult), and 92% of participants believed they performed the test correctly and received an accurate result. Lastly, men with higher motile sperm count were more likely to report feeling "at ease" or "excited" following testing, while men with low motile sperm count were more likely to report feeling "concerned" or "frustrated." Overall, 91% of men reported they would like to test again.
The Trak System provides a simple and potentially cost-effective means of measuring important semen parameters and may be useful in population-based epidemiologic fertility studies.
由于依赖集中式实验室精液分析，基于人群的流行病学研究中的精液质量评估存在后勤和财务方面的挑战。Trak 男性生育力测试系统是一种经过 FDA 批准和验证的、用于测量精子浓度和精液量的家庭使用测试系统，同时还具有仅供研究使用的精子活力测试。在这里，我们评估了 Trak 系统在参与北美夫妇生育计划的在线妊娠研究（Presto）的男性中的整体效用。
在研究招募时，年龄≥21 岁且尝试怀孕时间≤6 个月的美国男性参与者被邀请在完成基线问卷后参加精液测试子研究。同意参与的参与者收到了 Trak 引擎（带电池的离心机）和两个测试套件。参与者通过智能手机图像将测试结果上传到在线问卷中进行分享。然后，数据与基线问卷中的协变量数据进行了关联。
在受邀参加的 688 名男性中，有 373 名（54%）表示同意，有 271 名（73%）完成了至少一次精液测试结果。精液量、精子浓度、活动精子浓度、总精子数和总活动精子数的分布与 2010 年世界卫生组织（WHO）一般人群男性精液参数数据相似。Trak 系统的整体可用性评分为 5 分制中的 1.4 分（1=非常容易，5=困难），92%的参与者认为他们正确地进行了测试并获得了准确的结果。最后，精子活动度较高的男性在测试后更有可能感到“轻松”或“兴奋”，而精子活动度较低的男性更有可能感到“担忧”或“沮丧”。总体而言，91%的男性表示他们愿意再次进行测试。
Trak 系统提供了一种简单且具有潜在成本效益的测量重要精液参数的方法，可能对基于人群的流行病学生育力研究有用。
