Trial Outcomes & Findings for Assessment of TetraSOD® Efficacy to Improve Semen Parameters in Men With Idiopathic Infertility (NCT NCT04864314)
NCT ID: NCT04864314
Last Updated: 2026-03-27
Results Overview
Sperm progressive motility (in percentage) will be assessed according to the method described in the WHO (World Health Organization) laboratory manual for the examination and processing of human semen, 5th ed. Geneva: World Health Organization (2010)
COMPLETED
NA
80 participants
90 days
2026-03-27
Participant Flow
Participant milestones
| Measure |
Control Group
Group supplemented with a daily dose of placebo
Sham: Participants in the Control group will receive a daily dose of placebo in a capsule during 90 days. After treatment, the group will stop consumption of placebo and a wash-out period of three months will start
|
Experimental Group
Group supplemented with a daily dose of TetraSOD®
Marine microalgae Tetraselmis chuii with high Superoxide Dismutase (SOD) activity: Participants in the Experimental group will receive a daily dose of 250 mg of TetraSOD® in a capsule during 90 days. After treatment, the group will stop consumption of TetraSOD® and a wash-out period of three months will start
|
|---|---|---|
|
Visit 1 (3 Months of Supplementation)
STARTED
|
40
|
40
|
|
Visit 1 (3 Months of Supplementation)
COMPLETED
|
31
|
31
|
|
Visit 1 (3 Months of Supplementation)
NOT COMPLETED
|
9
|
9
|
|
Visit 2 (3 Months of Wash-out)
STARTED
|
31
|
31
|
|
Visit 2 (3 Months of Wash-out)
COMPLETED
|
23
|
26
|
|
Visit 2 (3 Months of Wash-out)
NOT COMPLETED
|
8
|
5
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Control Group
n=40 Participants
Group supplemented with a daily dose of placebo
Sham: Participants in the Control group will receive a daily dose of placebo in a capsule during 90 days. After treatment, the group will stop consumption of placebo and a wash-out period of three months will start
|
Experimental Group
n=40 Participants
Group supplemented with a daily dose of TetraSOD®
Marine microalgae Tetraselmis chuii with high Superoxide Dismutase (SOD) activity: Participants in the Experimental group will receive a daily dose of 250 mg of TetraSOD® in a capsule during 90 days. After treatment, the group will stop consumption of TetraSOD® and a wash-out period of three months will start
|
Total
n=80 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
37.13 years
STANDARD_DEVIATION 4.39 • n=40 Participants
|
37.02 years
STANDARD_DEVIATION 5.71 • n=40 Participants
|
37.075 years
STANDARD_DEVIATION 5.06 • n=80 Participants
|
|
Sex/Gender, Customized
Male
|
40 participants
n=40 Participants
|
40 participants
n=40 Participants
|
80 participants
n=80 Participants
|
|
Sex/Gender, Customized
Female
|
0 participants
n=40 Participants
|
0 participants
n=40 Participants
|
0 participants
n=80 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Spain
|
40 participants
n=40 Participants
|
40 participants
n=40 Participants
|
80 participants
n=80 Participants
|
|
Body Mass Index (BMI)
|
26.35 Kg/m^2
STANDARD_DEVIATION 3.81 • n=40 Participants
|
26.49 Kg/m^2
STANDARD_DEVIATION 4.36 • n=40 Participants
|
26.42 Kg/m^2
STANDARD_DEVIATION 4.07 • n=80 Participants
|
PRIMARY outcome
Timeframe: 90 daysSperm progressive motility (in percentage) will be assessed according to the method described in the WHO (World Health Organization) laboratory manual for the examination and processing of human semen, 5th ed. Geneva: World Health Organization (2010)
Outcome measures
| Measure |
Control Group
n=31 Participants
Group supplemented with a daily dose of placebo
Sham: Participants in the Control group will receive a daily dose of placebo in a capsule during 90 days. After treatment, the group will stop consumption of placebo and a wash-out period of three months will start
|
Experimental Group
n=31 Participants
Group supplemented with a daily dose of TetraSOD®
Marine microalgae Tetraselmis chuii with high Superoxide Dismutase (SOD) activity: Participants in the Experimental group will receive a daily dose of 250 mg of TetraSOD® in a capsule during 90 days. After treatment, the group will stop consumption of TetraSOD® and a wash-out period of three months will start
|
|---|---|---|
|
Sperm Progressive Motility
|
19.62 percentage
Standard Deviation 14.59
|
25.11 percentage
Standard Deviation 17.03
|
PRIMARY outcome
Timeframe: 90 daysSperm concentration will be determined according to the method described in the WHO laboratory manual for the examination and processing of human semen, 5th ed. Geneva: World Health Organization (2010)
Outcome measures
| Measure |
Control Group
n=31 Participants
Group supplemented with a daily dose of placebo
Sham: Participants in the Control group will receive a daily dose of placebo in a capsule during 90 days. After treatment, the group will stop consumption of placebo and a wash-out period of three months will start
|
Experimental Group
n=31 Participants
Group supplemented with a daily dose of TetraSOD®
Marine microalgae Tetraselmis chuii with high Superoxide Dismutase (SOD) activity: Participants in the Experimental group will receive a daily dose of 250 mg of TetraSOD® in a capsule during 90 days. After treatment, the group will stop consumption of TetraSOD® and a wash-out period of three months will start
|
|---|---|---|
|
Sperm Concentration
|
38.70 Million sperm/ml
Standard Deviation 53.72
|
37.79 Million sperm/ml
Standard Deviation 49.19
|
SECONDARY outcome
Timeframe: 90 daysDNA integrity/fragmentation was evaluated using the COMET assay. Approximately 10,000 sperm from cryopreserved samples were embedded in 1% low-melting-point agarose gel and subjected to lysis. Slides were immersed in either neutral or alkaline electrophoresis buffer for 30 min, followed by electrophoresis at 22 V for 10-15 min, maintaining current below 280 mA to prevent overheating. DNA was then stained with SYBR™ Gold (Invitrogen™, ThermoFisher scientific©, USA) and visualized by fluorescence microscopy. DNA fragments migrated further than intact chromatin, forming a characteristic comet tail. The percentage of fragmented sperm was quantified by analyzing 60-120 cells per sample.
Outcome measures
| Measure |
Control Group
n=31 Participants
Group supplemented with a daily dose of placebo
Sham: Participants in the Control group will receive a daily dose of placebo in a capsule during 90 days. After treatment, the group will stop consumption of placebo and a wash-out period of three months will start
|
Experimental Group
n=31 Participants
Group supplemented with a daily dose of TetraSOD®
Marine microalgae Tetraselmis chuii with high Superoxide Dismutase (SOD) activity: Participants in the Experimental group will receive a daily dose of 250 mg of TetraSOD® in a capsule during 90 days. After treatment, the group will stop consumption of TetraSOD® and a wash-out period of three months will start
|
|---|---|---|
|
DNA Integrity
Single-strand DNA fragmentation
|
31.29 percentage of sperm with fragmented DNA
Standard Deviation 10.25
|
30.31 percentage of sperm with fragmented DNA
Standard Deviation 12.52
|
|
DNA Integrity
Double-strand DNA fragmentation
|
31.41 percentage of sperm with fragmented DNA
Standard Deviation 15.31
|
26.60 percentage of sperm with fragmented DNA
Standard Deviation 11.28
|
SECONDARY outcome
Timeframe: 90 daysAny kind of adverse event attributable to TetraSOD® will be recorded during the duration of the trial
Outcome measures
| Measure |
Control Group
n=31 Participants
Group supplemented with a daily dose of placebo
Sham: Participants in the Control group will receive a daily dose of placebo in a capsule during 90 days. After treatment, the group will stop consumption of placebo and a wash-out period of three months will start
|
Experimental Group
n=31 Participants
Group supplemented with a daily dose of TetraSOD®
Marine microalgae Tetraselmis chuii with high Superoxide Dismutase (SOD) activity: Participants in the Experimental group will receive a daily dose of 250 mg of TetraSOD® in a capsule during 90 days. After treatment, the group will stop consumption of TetraSOD® and a wash-out period of three months will start
|
|---|---|---|
|
Adverse Effects
|
2 Number of participants
|
0 Number of participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 90 daysIn addition to seminal parameters and DNA fragmentation, sORP (static oxidation reduction potential) was also assessed using the MiOXSYS system. The MiOXSYS® galvanostatic system (Caerus Biotechnologies, Switzerland) was used to measure the balance between total oxidant and reductant activity in seminal plasma. For each measurement, 30 μl of fresh ejaculate was deposited on a single-use sample holder chip. The seminal sORP was then displayed in mV on the device screen and subsequently normalized to sperm concentration (sORP/C). Two different cohorts were defined in each experimental group, those presenting a pathological sORP/C (\>1.34 mV/million sperm/mL), and those presenting a non-pathological sORP/C (\<1.34 mV (millivolt)/million sperm/mL). Seminal parameters and DNA fragmentation wera analyzed in each cohort in each experimental group.
Outcome measures
| Measure |
Control Group
n=31 Participants
Group supplemented with a daily dose of placebo
Sham: Participants in the Control group will receive a daily dose of placebo in a capsule during 90 days. After treatment, the group will stop consumption of placebo and a wash-out period of three months will start
|
Experimental Group
n=31 Participants
Group supplemented with a daily dose of TetraSOD®
Marine microalgae Tetraselmis chuii with high Superoxide Dismutase (SOD) activity: Participants in the Experimental group will receive a daily dose of 250 mg of TetraSOD® in a capsule during 90 days. After treatment, the group will stop consumption of TetraSOD® and a wash-out period of three months will start
|
|---|---|---|
|
MiOXSYS System as a Diagnostic Test of Abnormal Seminal Parameters and DNA Fragmentation
|
2.59 mV/10^6 sperm/mL
Standard Deviation 2.67
|
3.17 mV/10^6 sperm/mL
Standard Deviation 3.25
|
Adverse Events
Control Group
Experimental Group
Serious adverse events
| Measure |
Control Group
n=31 participants at risk
Group supplemented with a daily dose of placebo
Sham: Participants in the Control group will receive a daily dose of placebo in a capsule during 90 days. After treatment, the group will stop consumption of placebo and a wash-out period of three months will start
|
Experimental Group
n=31 participants at risk
Group supplemented with a daily dose of TetraSOD®
Marine microalgae Tetraselmis chuii with high Superoxide Dismutase (SOD) activity: Participants in the Experimental group will receive a daily dose of 250 mg of TetraSOD® in a capsule during 90 days. After treatment, the group will stop consumption of TetraSOD® and a wash-out period of three months will start
|
|---|---|---|
|
Reproductive system and breast disorders
Protruding in testes
|
3.2%
1/31 • Number of events 1 • 3 months
|
0.00%
0/31 • 3 months
|
|
Reproductive system and breast disorders
Epididymitis
|
3.2%
1/31 • Number of events 1 • 3 months
|
0.00%
0/31 • 3 months
|
Other adverse events
Adverse event data not reported
Additional Information
Dr Meritxell Jodar
Molecular Biology of Reproduction and Development Research Group, Fundació Recerca Clínic Barcelona - IDIBAPS. Genetics Unit, Department of Biomedicine, Universitat de Barcelona (UB), Barcelona, Spain
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place