25 years research finds oxidative stress is a leading cause of damage to sperm function

Aytu BioScience, Inc., a specialty pharmaceutical company focused on products in the field of urology, today announced the publication of journal article describing the effectiveness of its MiOXSYS System for assessing the level of oxidative stress in semen as an aid in the diagnosis of infertility in men.

The article, titled, “Clinical Relevance of Oxidation-Reduction Potential in the Evaluation of Male Infertility,” will be published in the medical journal Urology, the “Gold Journal”.

Josh Disbrow, Chief Executive Officer of Aytu, said that the research spanning more than 25 years, leaves little doubt that oxidative stress is a leading cause of damage to sperm function, leading to failure to conceive or lack of embryo development.

Disbrow continued: “Yet until recently there have been no clinically feasible options for rapid, in-office testing for oxidative stress in semen. We are therefore pleased with the results of this study, which demonstrate that MiOXSYS may overcome many of the specific limitations of current methods for assessing sperm oxidative stress.”

The CEO  said that the study provides the first indication of how specific oxidative stress cut offs, as measured by MiOXSYS, might be used to help predict important parameters such as sperm motility, potentially distinguishing men with good semen quality from those with poor semen quality in a much simpler and cost-efficient manner than is used in andrology laboratories today.

Oxidative stress in sperm stems from excessive production of reactive oxygen species (ROS), which are found in 25-40% of infertile men yet remains difficult to measure with current laboratory methods. Currently, a combination of independent assays, both direct and indirect, are used to measure seminal ROS.  These antiquated methods, such as the chemiluminescence assay, are highly time sensitive, time consuming and expensive, limiting their feasibility for routine in-office or laboratory use.  They also provide an incomplete picture of the true oxidative stress environment since they are based on single-biomarker assays rather than on a global measure of oxidative stress.  MiOXSYS measures oxidation-reduction potential (ORP), which provides a comprehensive measure of oxidative stress by simultaneously accounting for all the known and unknown oxidants and antioxidants in the semen sample.

Aytu said that the results of the latest study showed MiOXSYS’s ability to accurately identify sperm quality and established OS as a key mechanism in patients suffering from oligozoospermia. Furthermore, the study also showed that ORP levels declined with increases in sperm concentration and motility in patients who had repeated semen analyses and ORP levels analyzed, demonstrating that ORP can serve as an indicator of sperm quality over time.

The company explained that receiver operating characteristic (ROC) analysis was used to establish the updated ORP cutoffs associated with infertile and fertile men.  Based on the cutoffs for infertile men (1.57 mV/106 sperm) and oligozoospermia (2.59 mV/106 sperm), the results indicated that men with poor sperm quality can be identified by the ORP values with a high degree of accuracy and repeatability.  Based on these cutoff values, the specificity was 88% and sensitivity 70%, whereas in oligozoospermia, sensitivity and specificity were higher at 88% and 91%.

Ashok Agarwal, Director of the Andrology Center at the Glickman Urological & Kidney Institute of  Cleveland Clinic and Director of the American Center for Reproductive Medicine, said that the identified a major etiological factor, oxidative stress, of male infertility along with predicting abnormal sperm quality. He said that the study has shown that ORP levels were able to predict poor sperm quality at the time of diagnosis and during repeated semen analysis testing, indicating its ability to monitor sperm quality throughout the patient continuum. “This makes it easier to diagnose oxidative stress-related infertility,” Agarwal.

MiOXSYS has obtained CE Marking for commercialization in Europe and other markets, as well as medical device clearance from Health Canada.  Aytu says it is currently pursuing an FDA clearance pathway in the United States.