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NCT02475395 · ClinicalTrials.gov registry record · NA
Study of the Consumer Use of a New Home Test to Measure Sperm Concentration
A NA study of Fertility, Male and Sub-Fertility, Male, sponsored by Sandstone Diagnostics.
- Completed
- Registry status
- NA
- Development phase
- 272
- Enrollment target
- 3
- Study locations
NCT02475395: Completed NA study of Fertility, Male and Sub-Fertility, Male, sponsored by Sandstone Diagnostics.
NCT02475395 is a NA study of Fertility, Male and Sub-Fertility, Male that has completed, run by Sandstone Diagnostics. The registered enrollment target is 272 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (81% lower). The trial reports 3 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02475395, a NA study of Fertility, Male and Sub-Fertility, Male, has completed, sponsored by Sandstone Diagnostics.
- COMPLETED
- Registry status
- NA
- Development phase
- 272 participants
- Enrollment target
- 3
- Study locations
Study 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.
Primary Outcome
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.
Conditions Studied
Interventions
- DEVICE TRAK device
Study Locations (3)
California
- California Reproductive Services: Huntington Reproductive Center - Encino
- San Fernando Valley Urological Associates Medical Group - Tarzana
New York
- Men's Fertility Laboratory - Great Neck
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 272 participants |
| Start Date | 2015-09-02 |
| Est. Completion | 2015-11 |
| Phase | NA |
What the finished NCT02475395 record still lists
NCT02475395 is an interventional study that assigns participants to a tested intervention. The registered 272 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (81% lower).
The record links to 2 conditions, with Fertility, Male appearing as the primary indexed condition, and to 1 intervention - of which TRAK device is the first listed.
NCT02475395 reports a single indexed study location in California, New York.
Frequently Asked Questions
What is clinical trial NCT02475395 about?
NCT02475395 is a clinical study titled "Study of the Consumer Use of a New Home Test to Measure Sperm Concentration". 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...
What is the current status of trial NCT02475395?
This trial is currently completed. It is a NA study. The enrollment target is 272 participants. The study started on 2015-09-02. Estimated completion is 2015-11.
What conditions does trial NCT02475395 study?
This clinical trial studies the following conditions: Fertility, Male, Sub-Fertility, Male.
What interventions are being tested in trial NCT02475395?
The interventions under investigation include: TRAK device (DEVICE).
Who is sponsoring clinical trial NCT02475395?
This trial is sponsored by Sandstone Diagnostics, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02475395 being conducted?
This trial has 3 study locations across California, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02475395's enrollment target sits among peer trials
272 387th of 2000 higher than 1,614 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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