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

Overview

  • Study type

    Observational
  • Study IDs

  • Describes the nature of a clinical study. Types include:

    • Observational study — observes people and measures outcomes without affecting results.
    • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
    • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
  • Site IRB
    • Rochester, Minnesota: 16-003328
    NCT ID: NCT02839447
    Sponsor Protocol Number: PCL-0002

About this study

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.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.

See eligibility criteria

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.

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Landon Trost, M.D.

Contact us for the latest status

Contact information:

Pamela Draayer CCRP

(507)293-2471

Draayer.Pamela@mayo.edu

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CLS-20270762

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