Clinical trial NCT02839447: A Clinical Evaluation of Semen Quality Using the MiOXSYS™ System 2.0
Official title: A Clinical Evaluation of Semen Quality Using the MiOXSYS™ System 2.0
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Male Infertility
Keywords: semen
sperm
oxidative stress
reactive oxygen species
idiopathic male infertility
Lead sponsor: Aytu BioPharma, Inc.
Sponsor class: INDUSTRY
First posted: 2016-07-21
Enrollment: 0
Sex: MALE
Minimum age (years): 21
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Human males interested in fertility

Brief 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 \[2010\]).

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.

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.

Primary outcomes:
measure: 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
Secondary outcomes:
Other outcomes:
Locations:
city: Miami
country: United States
facility: University of Miami
state: Florida
city: New Orleans
country: United States
facility: Tulane University
state: Louisiana
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
city: Odessa
country: United States
facility: Odessa Regional Medical Center
state: Texas
Study officials:
References:
citation: Agarwal A, Sharma RK, Sharma R, Assidi M, Abuzenadah AM, Alshahrani S, Durairajanayagam D, Sabanegh E. Characterizing semen parameters and their association with reactive oxygen species in infertile men. Reprod Biol Endocrinol. 2014 May 7;12:33. doi: 10.1186/1477-7827-12-33.
citation: Agarwal A, Mulgund A, Alshahrani S, Assidi M, Abuzenadah AM, Sharma R, Sabanegh E. Reactive oxygen species and sperm DNA damage in infertile men presenting with low level leukocytospermia. Reprod Biol Endocrinol. 2014 Dec 19;12:126. doi: 10.1186/1477-7827-12-126.
citation: Du Plessis SS, Agarwal A, Halabi J, Tvrda E. Contemporary evidence on the physiological role of reactive oxygen species in human sperm function. J Assist Reprod Genet. 2015 Apr;32(4):509-20. doi: 10.1007/s10815-014-0425-7. Epub 2015 Feb 3.
citation: Agarwal A, Sharma R, Roychoudhury S, Du Plessis S, Sabanegh E. MiOXSYS: a novel method of measuring oxidation reduction potential in semen and seminal plasma. Fertil Steril. 2016 Sep 1;106(3):566-573.e10. doi: 10.1016/j.fertnstert.2016.05.013. Epub 2016 May 31.