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

Overview

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:

  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 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

  • To measure oxidative reduction potential (ORP) in semen and seminal plasma and to establish their reference levels. Read More on PubMed
  • Reactive oxygen species (ROS) play an important role in male fertility. Overproduction of reactive oxygen species (ROS) has been associated with a variety of male fertility complications, including leukocytospermia, varicocele and idiopathic infertility. The subsequent oxidative insult to spermatozoa can manifest as insufficient energy metabolism, lipid peroxidation and DNA damage, leading to loss of motility and viability. However, various studies have demonstrated that physiological amounts of ROS play important roles in the processes of spermatozoa maturation, capacitation, hyperactivation and acrosome reaction. It is therefore crucial to define and understand the delicate oxidative balance in male reproductive cells and tissues for a better understanding of both positive as well as negative impact of ROS production on the fertilizing ability. This review will discuss the specific physiological roles, mechanisms of action and effects that ROS have on the acquisition of structural integrity and physiological activity of spermatozoa. Read More on PubMed
  • 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
  • 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

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CLS-20270762

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