Infertility is an increasing global public health problem present in about 15-20% of the
population of reproductive age, affecting as many as 186 million people worldwide. A male
factor is present in approximately 50% of the infertile couples, a large number of them
of unknown or idiopathic origin.
Spermatogenesis is a complex biological process that requires a highly regulated genetic
and hormonal program in a singular environment created by the interaction with different
cell types to orchestrate a successful differentiation process. This process occurs
periodically every 72 days during a man's fertile life. It has been demonstrated that
semen quality is deteriorating over the time, perhaps as a result of exposure to several
environmental factors related with lifestyle: drug use (such us tobacco, alcohol,
marijuana, cocaine, opioids and anabolic agents), diet and overweight, disorders of the
sleep-wake cycle and working conditions (continuous exposure to heat sources or toxic
substances) that could impact both directly and indirectly on the complex process of
spermatogenesis.
Currently, the impact of oxidative stress, a cellular state product of an imbalance
between the generation of highly unstable molecules known as reactive oxygen species
(ROS) and the antioxidant cellular capacity in male fertility is being deeply
investigated. High levels of oxidative stress in semen have been associated with both
lower sperm concentration, sperm motility and acrosome integrity and higher sperm DNA
damage and mitochondrial activity. Recent clinical trials have demonstrated the high
prevalence of sperm DNA damage by up to 80% of men diagnosed with idiopathic male
infertility. This DNA damage produced during spermatogenesis or sperm maturation process
could be the result of an increase of reactive oxygen species (ROS) in male reproductive
tract, which are related to different known factors (chronic systemic disease, use of
some drugs, radiation or pesticides, febrile processes, old age and environmental factors
related to lifestyle: smoking, obesity, alcohol) and other unknown so far.
Antioxidant supplementation has gained relevance within routine practices in patients
with reproductive problems. Different studies have shown the beneficial effect of
antioxidant consumption against oxidative damage caused by environmental and pathological
components, improving sperm characteristics associated with the seminal analysis. There
are scientific evidences about the improvement of male fertility and higher rates of live
newborn after antioxidant treatment in subfertile men.
TetraSOD® is a unique commercial product comprised of 100% lyophilized biomass of the
marine microalgae Tetraselmis chuii strain CCFM03 (Culture Collection of Fitoplancton
Marino 03), which is currently marketed for food and nutraceutical applications around
the world by the company Fitoplancton Marino, S.L. This microalgae product is
characterized by a high content in the antioxidant enzyme superoxide dismutase (SOD), as
it is produced using own patent-protected technology developed by the company. Results of
in vitro studies with human cell lines suggest that TetraSOD® stimulates the cellular
protective mechanisms against oxidative stress. Moreover, results previously obtained in
a pilot study with the highest dose of TetraSOD® (250 mg/day) were promising, since a
high statistically significant response was observed in three of the four studied
parameters after three months of treatment.
Taking into account these results, a new extended double-blind randomized and
placebo-controlled clinical study has been performed to confirm the positive effects of
dietary supplementation with 250 mg of TetraSOD® during 3 months (corresponding to the
time of a complete spermatogenic cycle) in sperm quality.
The main objective of this new study is to check the usefulness of a lower dose of
TetraSOD® (125 mg/day) in the improvement of sperm quality, including sperm DNA
fragmentation. As previously mentioned, oxidative stress is one of the main causes of
sperm DNA damage. Nowadays, a diagnostic test for the study of the sperm DNA
fragmentation exists, but it requires a specific sperm sample processing and the results
are obtained in delay-time. In this new trial, correlation between sperm DNA
fragmentation and static oxidation reduction potential (sORP) degree by the use of the
Male Infertility Oxidative System (MiOXSYS) will be also tested as in the previous one
with a higher dose of TetraSOD® (250 mg/day). Classical seminal parameters (semen volume,
sperm concentration and number, sperm progressive motility) will be also quantified. In
that way, with this new trial it will be possible to determine a range of TetraSOD®
dosage being clinically active for the treatment of male infertility.