Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 2:14 PM
Ignite Modification Date:
2025-12-24 @ 2:14 PM
NCT ID:
NCT02475395
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.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
20 Years
Maximum Age:
50 Years
Study:
NCT02475395
Study Brief:
Protocol Section:
NCT02475395