Skip to main content
OpenTrials
Completed

NCT Number: NCT02475395

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 the TRAK device.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Fertility, Male Genital Diseases Genital Diseases, Male Infertility Infertility, Male Male Urogenital Diseases Sub-Fertility, Male Urogenital Diseases

Age range

20 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

California Reproductive Services: Huntington Reproductive Center, Encino, California, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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.

Treatment and study plan

TRAK device

Device

Use of TRAK to attain sperm concentration measurement

Other names: Sperm Concentration

Primary outcomes

  1. 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

    Time frame: 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.

Secondary outcomes

  1. Number of Accurate and Inaccurate Subfertility Results as Obtained by Healthcare Professionals Observing Assays Result Performed by Untrained Lay Users.

    Time frame: Participants will be followed for one visit for up to 2 hours

    Healthcare professions obtained a categorical sperm concentration result by observing completed assay outputs as performed by Lay Users. Positive (for subfertility) results are less than or equal to 15 M/mL threshold. Reference result using gold standard (CASA) was measured and compared to Trak. True positive and true negative matched Reference category result and false negative, false positive did not match reference category result.

  2. Number of Accurate and Inaccurate Results Obtained by Healthcare Professionals Performing Trak Assays on Subjects' Samples.

    Time frame: Participants will be followed for one visit for up to 2 hours

    Healthcare professions obtained a categorical sperm concentration result by performing assay on aliquot obtained from Lay User's sample. Positive (for subfertility) results are less than or equal to 15 M/mL threshold. Reference result using gold standard (CASA) was measured and compared to Trak. True positive and true negative matched Reference category result and false negative, false positive did not match reference category result.

Sponsors and collaborators

Lead sponsor

Sandstone Diagnostics

Industry

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Jun 18, 2015
Registry last updated
Oct 18, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.