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Study of the Consumer Use of a New Home Test to Measure Sperm Concentration

NCT02475395 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 272

Last updated 2017-10-18

Study results available
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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.

Conditions

  • Fertility, Male
  • Sub-Fertility, Male

Interventions

DEVICE

TRAK device

Use of TRAK to attain sperm concentration measurement

Sponsors & Collaborators

  • Sandstone Diagnostics

    lead INDUSTRY

Principal Investigators

  • Eugene Dula, MD · San Fernando Valley Urological Associates Medical Group

  • Robert Boostanfar, MD · California Reproductive Services: Huntington Reproductive Center

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-09-02
Primary Completion
2015-11-30
Completion
2015-11-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02475395 on ClinicalTrials.gov