Study of the Consumer Use of a New Home Test to Measure Sperm Concentration
Completed · Not applicable
Conditions studied: Fertility, Male, Sub-Fertility, Male
In brief
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.
Key facts
- Study ID
- NCT02475395
- Run by
- Sandstone Diagnostics
- People needed
- 272
- Starts
- 2015-09-02
- Expected to finish
- 2015-11-01
- Last updated by the study team
- 2017-10-18
Who can join
Age: 20 and older, up to 50. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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
You may not qualify if…
- 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.
Where it is running
- California Reproductive Services: Huntington Reproductive Center — Encino, California, United States
- San Fernando Valley Urological Associates Medical Group — Tarzana, California, United States
- Men's Fertility Laboratory — Great Neck, New York, United States
Full record on ClinicalTrials.gov
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