Male InfertilityNCT02839447
A Clinical Evaluation of Semen Quality Using the MiOXSYS™ System 2.0
An observational study of Male Infertility, run by Aytu BioPharma, Inc. at 6 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Male Infertility
- What is being tested?
- Diagnostic
- How many people
- 0 participants
- Where
- 6 sitesUnited States
- Study dates
- Sep 2025to Apr 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Study population: Human males interested in fertility
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 13Show fewer
- 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.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Cleveland Clinic
Cleveland, Ohio, 44195
Baylor College of Medicine
Houston, Texas, 76798
University of Miami
Miami, Florida, 33146
Tulane University
New Orleans, Louisiana, 70118
Odessa Regional Medical Center
Odessa, Texas, 79761
Mayo Clinic
Rochester, Minnesota, 55905
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 (5th Edition WHO Laboratory Manual for the Examination and Processing of Human Semen [2010]).
Read the 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.
- Conditions
- Male Infertility
- Being tested
- Diagnostic
- Keywords
- semen, sperm, oxidative stress, reactive oxygen species, idiopathic male infertility
- Medical subject headings
- Infertility, Male
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DiagnosticDiagnostic test
Diagnostic
| Study group | Role | What they receive |
|---|---|---|
| Normal Semen | Semen that meet the criteria for "normal" on sperm number, motility, and morphology as described by the current WHO manual. Receives: Diagnostic Test: Diagnostic | |
| 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. Receives: Diagnostic Test: Diagnostic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Static Oxidation Reduction Potential (sORP) between Normal and Abnormal semen samples
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).
Measured: Semen samples, collected in accordance with published guidelines, will be tested within 1 hour of liquefaction
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2016 (estimated)
- Study startSep 2025 (estimated)
- Primary completionJan 2026 (estimated)
- Study completionApr 2026 (estimated)
Why it stopped: Study halted prematurely, prior to enrollment of first participant
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Male InfertilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aytu BioPharma, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02839447
- Sponsor's protocol ID
- PCL-0002
- Status last verified
- Mar 2024
- First submitted
- 15 Jul 2016
- Last updated
- 8 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 24885775Agarwal 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.
PubMed 25527074Du 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.
PubMed 25646893Agarwal 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.
PubMed 27260688
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Evaluation of Semen Quality Using the MiOXSYS™ System 2.0
- ClinicalTrials.gov ID
- NCT02839447
- Acronym / sponsor ID
- PCL-0002
- Conditions
- Male Infertility
- Keywords
- semen, sperm, oxidative stress, reactive oxygen species, idiopathic male infertility
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Study halted prematurely, prior to enrollment of first participant
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Aytu BioPharma, Inc.Industry (pharma, biotech, devices)
- Study start
- Sep 2025 (estimated)
- Primary completion
- Jan 2026 (estimated)
- Study completion
- Apr 2026 (estimated)
- First posted
- 21 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Normal Semen | – | Diagnostic Test: DiagnosticSemen that meet the criteria for "normal" on sperm number, motility, and morphology as described by the current WHO manual. |
| Abnormal Semen | – | Diagnostic Test: DiagnosticSemen 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. |
Who may qualify
- Ages
- 21 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Human males interested in fertility
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DiagnosticDiagnostic | Diagnostic test | Abnormal Semen, Normal Semen |
Primary outcome
Static Oxidation Reduction Potential (sORP) between Normal and Abnormal semen samples
Time frame: 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).
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2024.
- Background: PubMed 24885775Agarwal 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.
- Background: PubMed 25527074Agarwal 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.
- Background: PubMed 25646893Du 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.
- Background: PubMed 27260688Agarwal 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Male Infertility, run by Aytu BioPharma, Inc. at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 8 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Static Oxidation Reduction Potential (sORP) between Normal and Abnormal semen samples (time frame: Semen samples, collected in accordance with published guidelines, will be tested within 1 hour of liquefaction). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02839447, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Mar 2024.