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

NCT02839447 | Withdrawn

• 1 other identifier: PCL-0002
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 6

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 \[2010\]).

Conditions

Male Infertility

Keywords

semen; sperm; oxidative stress; reactive oxygen species; idiopathic male infertility

Outcome Measures

Primary Outcomes (1)

• 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).

  Semen samples, collected in accordance with published guidelines, will be tested within 1 hour of liquefaction

Study Arms (2)

Normal Semen

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

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.

Diagnostic Test: Diagnostic

Interventions

Diagnostic DIAGNOSTIC_TEST

Diagnostic

Abnormal Semen; Normal Semen

Eligibility Criteria

• Age: 21 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Human males interested in fertility

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Aytu BioPharma, Inc.: lead

Study Sites (6)

University of Miami

Miami, Florida, 33146, United States

Location

Tulane University

New Orleans, Louisiana, 70118, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Baylor College of Medicine

Houston, Texas, 76798, United States

Location

Odessa Regional Medical Center

Odessa, Texas, 79761, United States

Location

Related Publications (4)

• 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.

  PMID: 24885775 BACKGROUND

• 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.

  PMID: 25527074 BACKGROUND

• 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.

  PMID: 25646893 BACKGROUND

• 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.

  PMID: 27260688 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

human male semen containing sperm

MeSH Terms

Conditions

Infertility, Male

Interventions

Diagnosis

Condition Hierarchy (Ancestors)

Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Infertility; Male Urogenital Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 15, 2016
• First Posted: July 21, 2016
• Study Start: September 1, 2025
• Primary Completion: January 1, 2026
• Study Completion: April 1, 2026
• Last Updated: March 8, 2024

Record last verified: 2024-03

Locations

US (6)