A Clinical Evaluation of Semen Quality Using the MiOXSYS™ System 2.0 (NCT02839447) | Clinical Trial Compass
WithdrawnNot Applicable
A Clinical Evaluation of Semen Quality Using the MiOXSYS™ System 2.0
Stopped: Study halted prematurely, prior to enrollment of first participant
United States0Started 2025-09
Plain-language summary
The purpose of this study is to determine if elevations in oxidative stress, as measured by oxidation-reduction potential (ORP), can distinguish between semen samples from men with abnormal semen parameters from those with normal semen parameters. Static ORP (sORP) results, measured by the MiOXSYS System- a novel technology, will be compared to the current World Health Organization (WHO) semen analysis parameters (5th Edition WHO Laboratory Manual for the Examination and Processing of Human Semen \[2010\]).
Who can participate
Age range
21 Years – 45 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Between 21 and 45 years of age, inclusive.
. Male at birth.
. Sexually abstinent for a minimum of 48 hours.
. Sexually abstinent for no more than 7 days.
. Provides written informed consent.
. Agrees to complete all aspects of the study.
Exclusion criteria
. Diagnosis of azoospermia.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Static Oxidation Reduction Potential (sORP) between Normal and Abnormal semen samples
Timeframe: Semen samples, collected in accordance with published guidelines, will be tested within 1 hour of liquefaction
. Enrolled in another clinical study at the time of screening.
. Diagnosed and/or is taking chronic medication for a chronic gastrointestinal condition including irritable bowel syndrome, colitis, or similar metabolic dietary conditions.
. History of prostate cancer or any cancer that has been active over the last 5 years.