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

Sponsor

Aytu BioPharma, Inc. (Industry)

Overall Status

Withdrawn

CT.gov ID

NCT02839447

Collaborator

(none)

Enrollment

Locations

Anticipated Duration (Months)

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

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]).

Condition or Disease	Intervention/Treatment	Phase
Male Infertility	Other: no intervention

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 Design

Study Type:

Observational

Actual Enrollment :

0 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Anticipated Study Start Date :

Sep 1, 2016

Anticipated Primary Completion Date :

Jan 1, 2017

Anticipated Study Completion Date :

Apr 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Normal Semen Semen that meet the criteria for "normal" on sperm number, motility, and morphology as described by the current WHO manual.	Other: no intervention
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.	Other: no intervention

Arm

Intervention/Treatment

Normal Semen

Semen that meet the criteria for "normal" on sperm number, motility, and morphology as described by the current WHO manual.

Other: no intervention

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.

Other: no intervention

Outcome Measures

Primary Outcome Measures

Static Oxidation Reduction Potential (sORP) between Normal and Abnormal semen samples [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).

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years to 45 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Miami	Miami	Florida	United States	33146
2	Tulane University	New Orleans	Louisiana	United States	70118
3	Mayo Clinic	Rochester	Minnesota	United States	55905
4	Cleveland Clinic	Cleveland	Ohio	United States	44195
5	Baylor College of Medicine	Houston	Texas	United States	76798
6	Odessa Regional Medical Center	Odessa	Texas	United States	79761