A multicenter study to evaluate oxidative stress by oxidation-reduction potential, a reliable and reproducible method

Area of Science:

• Reproductive Medicine
• Andrology
• Biochemistry

Background:

• Seminal oxidative stress (OS) significantly affects male fertility, but inconsistent measurement methods hinder clinical application.
• Current OS tests often measure single markers, lacking standardization and comprehensive assessment.
• Oxidation-reduction potential (ORP) provides a holistic measure of oxidant and reductant activity, emerging as a superior OS indicator.

Purpose of the Study:

• To evaluate the reliability and reproducibility of Oxidation-reduction potential (ORP) measurements for assessing seminal oxidative stress (OS) in differentiating fertile from infertile semen samples.
• To compare ORP assessment with traditional semen analysis parameters across two international laboratories.
• To establish a standardized ORP cutoff value for clinical utility in male fertility assessment.

Main Methods:

• A retrospective study comparing semen analysis and MiOXSYS ORP data from 194 patients and 51 fertile donors (USA) and 400 patients and 50 fertile donors (Qatar) over 12 months.
• Standardized protocols were applied in both andrology laboratories.
• Receiver Operating Characteristic (ROC) analysis was used to determine the ORP cutoff value for differentiating fertile and infertile groups.

Main Results:

• Infertile men consistently exhibited higher ORP levels and poorer semen parameters (sperm concentration, motility, morphology) compared to fertile men across both datasets (p < 0.05).
• While traditional semen parameters showed significant inter-center variability, ORP levels remained consistent between the USA and Qatar laboratories (p = 0.08).
• An ORP cutoff of 1.42 mV/10^6/mL demonstrated high accuracy in distinguishing fertile from infertile semen in both individual datasets and the combined data.

Conclusions:

• ORP measurement via MiOXSYS is a reproducible and reliable tool for assessing seminal oxidative stress, consistently differentiating fertile from infertile semen across different geographical locations.
• The established ORP cutoff value provides a standardized metric for clinical use in male fertility evaluations.
• ORP assessment offers a more standardized and reliable approach to evaluating male fertility compared to traditional, variable semen parameters.