A Clinical Study Evaluating Consumer Use of a New Device (TRAK) to Measure Sperm Concentration From Human Semen Samples, and Comparing TRAK Test Results With Laboratory Reference Method Testing
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 272
- 试验地点
- 6
- 主要终点
- Number of Untrained Lay Users That Obtained Accurate and Inaccurate Subfertility Results From the TRAK Device When Compared to Results Obtained From the Gold Standard
研究概览
简要总结
The objective of the study is to evaluate the agreement in measurement of sperm concentration in human semen between lay users with TRAK and a recognized reference method. The study will also include the measurement of matched samples by TRAK when tested by healthcare professionals trained in use of the TRAK device.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects (Donor/Tester)
- •Generally healthy (apart from fertility or reproductive care), ambulatory, and have absence of chronic conditions or treatments, except those related to fertility and reproductive care
- •20 - 50 years of age inclusive
- •Male sex (subjects providing and/or testing human semen specimens)
- •For males providing human semen specimens, either healthy subjects or men receiving health care for any one or more of the following reasons:
- •Partner in a couple having difficulty conceiving
- •Diagnosed with male factor infertility
- •Post-vasectomy patients
- •Post-vasectomy reversal patients
- •Testers Only
- •Be able to provide signed Informed Consent
- •20 - 50 years of age inclusive
排除标准
- •Any medical or personal issue that would impair the ability of the subject to adhere to the protocol (e.g. substance abuse, neurological disorders)
- •Patients currently taking investigational drugs or who are active participants in a treatment trial for any condition
- •Unable to speak, understand, or write English
- •Mental illness that would interfere with understanding during the discussion of Informed Consent or that would compromise ability to follow the study protocol including, but not limited to, review of the TRAK™ Instructional Booklet, semen specimen collection, and semen specimen testing.
研究组 & 干预措施
Donor/Tester Subjects
Male subjects use the TRAK device to attain a measurement of sperm concentration from their semen specimen
干预措施: TRAK device (Device)
Tester Only Subjects
Male or female subjects use the TRAK device to attain a measurement of sperm concentration from another donor's semen specimen.
干预措施: TRAK device (Device)
结局指标
主要结局
Number of Untrained Lay Users That Obtained Accurate and Inaccurate Subfertility Results From the TRAK Device When Compared to Results Obtained From the Gold Standard
时间窗: Participants will be followed for one visit for up to 2 hours
Lay users obtained categorical sperm concentration result. Positive (for subfertility) results are less than or equal to 15 M/mL threshold. Gold standard reference (analysis by Computer-aided Semen Analysis \[CASA\]) result was measured and compared to Trak. True positive and true negative matched Reference category result and false negative, false positive did not match gold standard reference category result.
次要结局
- Number of Accurate and Inaccurate Subfertility Results as Obtained by Healthcare Professionals Observing Assays Result Performed by Untrained Lay Users.(Participants will be followed for one visit for up to 2 hours)
- Number of Accurate and Inaccurate Results Obtained by Healthcare Professionals Performing Trak Assays on Subjects' Samples.(Participants will be followed for one visit for up to 2 hours)