At a glance
ClinicalIndex Comparison RecordN/ACompleted· 272 enrolled
Drug / intervention
TRAK devicedevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A clinical study evaluating TRAK device for Fertility, Male and Sub-Fertility, Male. Completed, enrolled 272 participants across 3 sites.
Detailed Summary
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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsFertility, Male, Sub-Fertility, Male
CountriesUnited States
Collaborators--
Timeline
N/ACompletedFinished
20162017201820192020202120222023202420252026
First PostedJun 2015
Enrollment StartSep 2015
Primary CompletionNov 2015
TodayJul 2026
First PostedJun 18, 2015
Enrollment StartSep 2, 2015
Primary CompletionNov 1, 2015
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 11.0 years ago
Interventions
TRAK devicedevice
Use of TRAK to attain sperm concentration measurement