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 range21 Years – 45 Years

SexMALE

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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.
✕. Study participant on a previous date.
✕. Unable to complete all aspects of the study.
✕. 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.
✕. Vasectomy.
✕. Surgery in the previous 90 days.

What they're measuring

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

Trial details

NCT IDNCT02839447

SponsorAytu BioPharma, Inc.

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2026-01

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