Ignite Creation Date:
2024-05-06 @ 8:17 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06324071
Status:
RECRUITING
Last Update Posted:
2024-03-22
First Post:
2024-03-15
Brief Title:
Study to Verify the Efficacy of a Product Containing 125 mg of TetraSOD for the Treatment of Male Infertility
Sponsor:
Fitoplancton Marino SL
Organization:
Fitoplancton Marino SL
Study Overview
Official Title:
A Double-blind Randomized Placebo-controlled Clinical Study to Verify the Efficacy of TetraSOD in the Improvement of Semen Quality in Patients With iIdiopathic Infertility
Status:
RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
TetraSOD is a unique marine phytoplankton Tetraselmis chuii SOD-rich ingredient that is grown under patent-protected technology exclusively designed by the company Fitoplancton Marino SL Spain In a previous pilot trial the ability of TetraSOD dose 250 mgday to improve semen characteristics in idiopathic infertile men after three months of treatment was assessed revealing significant improvements in almost all of the analyzed parameters In a further clinical trial close to finish ClinicalTrialsgov Identifier NCT04864314 using the same dose such positive results have been tested again in a higher number of patients and additional parameters have been included in order to gain insights into the sperm physiological changes that underpin the improvement in semen quality In this new clinical trial an intermediate dose 125 mgday is going to be tested in an attempt to determine a range of TetraSOD dosage being clinically active for the treatment of male infertility
Detailed Description:
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 mans fertile life It has been demonstrated that semen quality is deteriorating over the time perhaps as a result of exposition 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 exposition 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 which is currently marketed for food and nutraceutical applications around the world by the company Fitoplancton Marino SL This microalgae product is characterized by a high content in the antioxidant enzyme superoxide dismutase SOD as it is produced using own patent pending 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 mgday 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 mgday 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 mgday 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
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 mans fertile life It has been demonstrated that semen quality is deteriorating over the time perhaps as a result of exposition 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 exposition 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 which is currently marketed for food and nutraceutical applications around the world by the company Fitoplancton Marino SL This microalgae product is characterized by a high content in the antioxidant enzyme superoxide dismutase SOD as it is produced using own patent pending 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 mgday 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 mgday 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 mgday 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None