N/A N=272 Randomized Diagnostic

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

Fertility, Male · Sub-Fertility, Male

Bottom Line

View on ClinicalTrials.gov: NCT02475395 ↗

Enrolled (actual)

272

Serious AEs

0.0%

Results posted

Jul 2017

Primary outcome: Primary: 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 — 52; 2; 160; 7 Participants

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: TRAK device (Device)
Age: Adult · 20+ yrs
Sex: All
Sponsor: Sandstone Diagnostics
Primary completion: Nov 2015

Outcome Measures

Outcome	Result	p-value
PRIMARY 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	52; 2; 160; 7; 10; 2	—
SECONDARY Number of Accurate and Inaccurate Subfertility Results as Obtained by Healthcare Professionals Observing Assays Result Performed by Untrained Lay Users.	56; 1; 161; 7; 9; 2	—
SECONDARY Number of Accurate and Inaccurate Results Obtained by Healthcare Professionals Performing Trak Assays on Subjects' Samples.	57; 1; 160; 7; 9; 2	—

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.

Eligibility Criteria

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02475395). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.