P-082 Use of TetraSOD® in male infertility: double-blind randomized placebo-controlled study

Abstract

Study question

Can the use of TetraSOD^® (microalgae with high content of the antioxidant enzyme superoxide dismutase) improve semen quality and reduce oxidative stress in sperm?

Summary answer

The use of TetraSOD^® reduces the oxidative stress of sperm, increasing the total sperm count in oligozoospermia and reducing the double-stranded DNA sperm fragmentation.

What is known already

Male factor is present in approximately 50% of the infertile couples, a large number of them of unknown or idiopathic origin. It has been demonstrated that semen quality is deteriorating over time, perhaps as a result of exposure to several environmental factors related with lifestyle that could impact both directly and indirectly on the complex process of spermatogenesis. Some of these bad habits of lifestyle increase the levels of oxidative stress in semen, which is associated with lower sperm concentration and motility. In this scenario, the use of antioxidants can be useful to increase sperm quality.

Study design, size, duration

Double-blind randomized placebo-controlled clinical study to assess the effect of 250 mg of TetraSOD^® (microalgae with high content of the primary antioxidant enzyme superoxide dismutase). Eighty patients with idiopathic infertility showing asthenozoospermia, oligozoospermia or oligoasthenozoospermia were recruited and randomized to receive 250 mg of TetraSOD^® (TSOD group) or placebo (Placebo group) for 3 months.

Participants/materials, setting, methods

Men with asthenozoospermia, oligozoospemia or aligoastenozoospermia and idiopatic infertility were recruited after informed consent signature. Patients were randomized into two groups. TetraSOD^® group received 250 mg of TetraSOD^®during 3 months, and Placebo group received capsules without TetraSOD^® during the same period of time. Seminogram, double-strand sperm DNA fragmentation (COMET assay) and sORP (static oxidation- reduction potential) were studied at baseline (V0) and after 3 months (V3).

Main results and the role of chance

TetraSOD^® consumption for three months elicited a statistically significant increase (Wilcoxon matched-pairs signed rank test; p=0.02) in the average number of sperms per ejaculate (from 17.06 x 10⁶ to 41.94 x 10⁶) in participants displaying oligozoospermia (<39 x 10⁶ sperms) at V0. In contrast, the lower variation in the measured values in the Placebo group was not statistically significant.

Regarding sORP, a statistically significant decrease (Wilcoxon matched-pairs signed rank test; p=0.0233) was observed in participants who displayed a value at V0 between 1.34-10. After TetraSOD^® consumption, the average changed from 2.96 to 1.91 mv/10⁶ sperm/ml from V0 to V3. However, not statistically significant changes were detected in the Placebo group between sORP values at V0 and V3.

Moreover, in relation to double-stranded DNA breaks, a statistically significant decrease (Wilcoxon matched-pairs signed rank test; p=0.01) in the average percentages (from 31.81% to 25.93%) was measured after consumption of TetraSOD^® at V3 in participants displaying a compromised redox status (sORP>1.34-10) at V0. No significant changes were found in the Placebo group.

Limitations, reasons for caution

The study was performed only in one ethnic group, so in future studies other ethnicities should be included.

Wider implications of the findings

TetraSOD^® may improve male fertility because increases the number of sperms per ejaculate in oligozoospermia and reduces double-stranded DNA fragmentation in sperm when individuals display an altered redox status in semen. Such results might be related to the indirect antioxidant effect of TetraSOD^®, reducing oxidative stress in seminal fluid.

Trial registration number

Not applicable