Study of the Consumer Use of a New Home Test to Measure Sperm Concentration (NCT02475395) | Clinical Trial Compass
CompletedNot Applicable
Study of the Consumer Use of a New Home Test to Measure Sperm Concentration
United States272 participantsStarted 2015-09-02
Plain-language 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.
Who can participate
Age range20 Years – 50 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 TRAKâ„¢ Instructional Booklet, semen specimen collection, and semen specimen testing.
What they're measuring
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
Timeframe: Participants will be followed for one visit for up to 2 hours