A Clinical Evaluation of Semen Quality Using the MiOXSYS™ System 2.0

March 6, 2024 updated by: Aytu BioPharma, Inc.
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]).

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

Oxidative stress reflects an imbalance in the redox system in favor of the activity of reactive oxygen species and other free radicals. It is also dependent upon the biological system's ability to detoxify these oxidative compounds through the application of antioxidants and other reductants. Disturbances in the normal redox state can cause adverse effects on cells including protein oxidation, lipid peroxidation, and DNA fragmentation.

Male infertility has been associated with oxidative stress. Higher levels of reactive oxygen species (ROS) have been found in semen from men with low sperm count and motility, and poor sperm morphology, suggesting an imbalance in the redox system and an opportunity to use oxidative stress as a biomarker for semen quality. While several methods are available for measuring oxidative stress, they are not being implemented routinely in semen analysis likely because they are arduous and typically reflect only one side of the redox balance- oxidant activity.

A quick and all-inclusive measure of oxidative stress that could be used in a diagnostic setting (academic, hospital, clinical or reference laboratory) is the measure of static oxidation reduction potential (sORP) ; sORP reflects an integrated measure of the redox balance taking into account the activity of all oxidants (i.e. ROS, reactive nitrogen species, transition metal ions) and all antioxidants (i.e. small molecule antioxidants like ascorbate and enzymatic antioxidants like glutathione). Because sORP values are an integrated measures of both sides of the redox balance, sORP levels could be an identifying characteristic of semen quality.

The MiOXSYS System measures the redox balance by measuring sORP values. The MiOXSYS test results is used in conjunction with the established WHO semen analysis parameters. Previous studies suggest that increases in sORP are associated with lower sperm numbers, fewer motile sperm, and more abnormal sperm morphologies. The advantage of the MiOXSYS System is that sORP measures take into account both the oxidant and antioxidant sides of the redox balance, providing a rapid measure of oxidative stress, all with no sample preparation.

The objective of this study is to evaluate the performance of the MiOXSYS System as it measures sORP in semen samples with various degrees of semen quality. The MiOXSYS System is comprised of the MiOXSYS Analyzer and disposable, single-use MiOXSYS Sensors. Thirty microliters (30 uL) of neat semen is required for each test. sORP results from each semen sample will be compared to their corresponding results on the WHO semen analysis parameters (5th Edition Laboratory Manual for the Examination and Processing of Human Semen [2010]), which is the current methods for assessing semen quality.

Study Type

Observational

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Miami, Florida, United States, 33146
        • University of Miami
    • Louisiana
      • New Orleans, Louisiana, United States, 70118
        • Tulane University
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic
    • Texas
      • Houston, Texas, United States, 76798
        • Baylor College of Medicine
      • Odessa, Texas, United States, 79761
        • Odessa Regional Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Human males interested in fertility

Description

Inclusion Criteria:

  1. Between 21 and 45 years of age, inclusive.
  2. Male at birth.
  3. Sexually abstinent for a minimum of 48 hours.
  4. Sexually abstinent for no more than 7 days.
  5. Provides written informed consent.
  6. Agrees to complete all aspects of the study.

Exclusion Criteria:

  1. Diagnosis of azoospermia.
  2. Study participant on a previous date.
  3. Unable to complete all aspects of the study.
  4. Enrolled in another clinical study at the time of screening.
  5. Diagnosed and/or is taking chronic medication for a chronic gastrointestinal condition including irritable bowel syndrome, colitis, or similar metabolic dietary conditions.
  6. History of prostate cancer or any cancer that has been active over the last 5 years.
  7. Vasectomy.
  8. Surgery in the previous 90 days.
  9. Trauma in the previous 90 days.
  10. Takes additional daily antioxidant supplements including Vitamin C, Beta-Carotene, Vitamin E, Zinc, N-acetylcysteine, or Selenium. Multivitamin is acceptable for inclusion into the study.
  11. Semen sample does not liquefy in 60 minutes.
  12. White blood cells and/or round cells are greater than or equal to 1 million sperm/mL.
  13. Sperm concentration in semen sample is less than 1 million sperm/mL.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Normal Semen
Semen that meet the criteria for "normal" on sperm number, motility, and morphology as described by the current WHO manual.
Diagnostic test: Diagnostic
Diagnostic
Abnormal Semen
Semen that fail to achieve one or more of the criteria for "normal" on sperm number, motility, and morphology as described by the current WHO manual.
Diagnostic test: Diagnostic
Diagnostic

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Static Oxidation Reduction Potential (sORP) between Normal and Abnormal semen samples
Time Frame: Semen samples, collected in accordance with published guidelines, will be tested within 1 hour of liquefaction
Determine potential differences in sORP between the group of semen samples ("Normal") that meet WHO parameters for normal (good quality) semen and the group of semen samples ("Abnormal") that fail one or more WHO parameters (see Group description above). sORP is recorded as millivolts per sperm concentration (mV/million sperm/mL).
Semen samples, collected in accordance with published guidelines, will be tested within 1 hour of liquefaction

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aytu BioPharma, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 1, 2025

Primary Completion (Estimated)

January 1, 2026

Study Completion (Estimated)

April 1, 2026

Study Registration Dates

First Submitted

July 15, 2016

First Submitted That Met QC Criteria

July 18, 2016

First Posted (Estimated)

July 21, 2016

Study Record Updates

Last Update Posted (Actual)

March 8, 2024

Last Update Submitted That Met QC Criteria

March 6, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PCL-0002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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