A Clinical Evaluation of Semen Quality Using the MiOXSYS™ System 2.0
Overview
Tab Title Description
Study type
ObservationalDescribes 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.
Study IDs
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. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
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.
- Trauma in the previous 90 days.
- 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.
- Semen sample does not liquefy in 60 minutes.
- White blood cells and/or round cells are greater than or equal to 1 million sperm/mL.
- Sperm concentration in semen sample is less than 1 million sperm/mL.
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Rochester, Minn.
Mayo Clinic principal investigator Matthew Ziegelmann, M.D. |
Closed for enrollment |
|
More information
Publications
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Leukocytes contribute directly and indirectly to reactive oxygen species (ROS) production. Although leukocytospermia is defined as the presence of ≥ 1 × 106 white blood cells/mL (WBC/mL) in a semen sample, the presence of less than 1×10(6) WBC/mL (low-level leukocytospermia) can still produce a detectable amount of ROS, impairing sperm function and lowering the chances of pregnancy. Our objective was to assess the effect of low-level leukocytospermia on semen quality, ROS levels, and DNA damage in infertile men.
Read More on PubMed
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A routine semen analysis is a first step in the laboratory evaluation of the infertile male. In addition, other tests such as measurement of reactive oxygen species can provide additional information regarding the etiology of male infertility. The objective of this study was to investigate the association of semen parameters with reactive oxygen species (ROS) in two groups: healthy donors of unproven and proven fertility and infertile men. In addition, we sought to establish an ROS cutoff value in seminal plasma at which a patient may be predicted to be infertile.
Read More on PubMed