Male InfertilityNCT04959864
Efficacy Study of a Food Supplement With Myo-inositol, N-Acetyl-Cystein, Zinc and Vitamins on Sperm DNA Fragmentation
A study testing Isitol® in people with Male Infertility, run by GYNOV at 1 site in France.
Trial summary
In industrialised countries, it is estimated that about 15% of couples who wish to have a child are currently facing infertility problems, of which, in half of the cases, an anomaly in sperm quality or at least a factor of male origin is identified. Read more about this study
- Who is it for?
- Ages 20 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Male Infertility
- What is being tested?
- Isitol®
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 1 siteFrance
- Study dates
- 7 Jul 2021to Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Sperm DNA fragmentation rate ≥ 30 %
Who cannot join
- Positive semen culture
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Laboratoire Drouot
Paris, 75009
Axel Dries, Master, +33636630660 ext. +33547742633, a.dries@gynov.com
Pierre-Yves Mousset, MD, +33616310400 ext. +33547742633, py.mousset@gynov.com
About this study
Official title: Double-Blind Randomized Controlled Trial Evaluating the Efficacy of the Food Supplement Isitol® Versus Placebo on the Rate of Abnormal Sperm DNA Fragmentation
In industrialised countries, it is estimated that about 15% of couples who wish to have a child are currently facing infertility problems, of which, in half of the cases, an anomaly in sperm quality or at least a factor of male origin is identified. The evaluation of sperm quality in males is based, for the most part, on the micro and macroscopic examination of various parameters (concentration, motility, physical abnormalities of the spermatozoa, etc.). Nevertheless, an increasing number of scientific studies have shown that the quality of sperm DNA, and in particular its fragmentation rate, is also associated with a lower fertilisation rate. The integrity of sperm DNA may be affected by an imbalance in the Red/Ox balance leading to uncompensated oxidative stress, and could be restored or improved by dietary hygiene measures and the consumption of specific dietary products. The ISITOL clinical study aims to evaluate the efficacy of a dietary supplement specifically formulated to target the various issues associated with male infertility, and in particular to contribute to the improvement of the sperm DNA fragmentation rate. The efficacy of the dietary supplement Isitol® (GYNOV SAS) on sperm DNA fragmentation rate and other secondary parameters is being evaluated through a single-centre, prospective, randomised, double-blind, interventional vs. placebo clinical study being conducted in France at Laboratoire Drouot (21 Rue Drouot - 75009 Paris - France) and led by Dr. Nino-Guy Cassuto. A total of 72 men aged between 20 and 45 years, with sperm DNA fragmentation rate ≥ 30% and with negative semen culture are recruited. The recruited patients were randomized in a 1:1 scheme into 2 groups (Isitol® treated vs placebo treated).
[Results to be reported later]
Read the detailed description
Infertility is generally defined as a partner's failure to conceive after at least 12 months off contraception and is steadily increasing worldwide. In industrialised countries, it is estimated that around 15% of couples who wish to have a child are now facing it, and in half of the cases, an abnormality in sperm quality or at least a male factor is identified.
In males, the measurement of male fertility is mainly based on analyses that assess sperm quality macroscopically (spermiogram, spermocytogram) by evaluating the number, morphology, motility, presence of abnormalities, etc. These indicators are still considered to be the preferred indicators for assessing male fertility.
Nevertheless, since the mid-2000s, numerous in vitro and in vivo studies in humans and animals have shown that the integrity of sperm DNA, assessed by measuring the rate of DNA fragmentation and chromatin decondensation in spermatozoa, could be a relevant parameter in the etiology of male infertility. Furthermore, it has been observed that the rate of sperm DNA fragmentation is inversely correlated with pregnancy rate, success rate of assisted reproductive techniques and embryo quality.
The major identified cause of direct damage to DNA molecules and their possible fragmentation, but also to proteins and cell membranes in spermatozoa is oxidative stress. Unreduced Reactive oxygen species produced in the mitochondria-rich midpiece in excess are susceptible to damage the DNA in the sperm head. Several exogenous factors such as exposure to toxins, smoking, alcohol or unbalanced diet are also associated with promoting oxidative stress.
A fragmentation rate higher than 30% is considered high, it is indicative of altered chromatin and especially associated with a low probability of conceiving naturally or through in vitro techniques.
To resolve this problem and improve the process of spermatogenesis and fertilisation, it is relevant to evaluate the effectiveness of a food supplement (Isitol®), manufactured and marketed by the company Gynov SAS (2B Rue Sauteyron - 33000 Bordeaux - France), which provides myo-inositol and a complex with antioxidant properties based on N-acetyl-cysteine, group B vitamins (B2, B3, B6, B9), vitamin E and zinc.
In addition to providing the nutrients that contribute to a better management of the reactive oxygen species, the food supplement provides myo-inositol, which is essential for the functioning of a wide range of cellular functions. This molecule, related to glucose, is produced in the testis, mainly by Sertoli cells, and is excreted into the seminiferous tubules as a gradient. This gradient contributes to sperm maturation by reducing sperm viscosity and increasing sperm motility. Numerous studies evaluating the impact of myo-inositol have shown a significant improvement in sperm parameters (concentration, motility, morphology) and in particular in the rate of sperm DNA fragmentation.
In order to evaluate the efficacy of this dietary supplement, a single-centre, prospective, randomised, double-blind, interventional vs. placebo clinical study was set up in France at Laboratoire Drouot (21 Rue Drouot - 75009 Paris - France) and directed by Dr. Nino-Guy Cassuto. A total of 72 men aged between 20 and 45 years, with sperm DNA fragmentation rate ≥ 30% and with negative semen culture are recruited. The recruited patients were randomised in a 1:1 design into 2 groups (Isitol® treated vs placebo treated).
The primary hypothesis is that after 16 (± 2) weeks of treatment with the dietary supplement, the expected decrease in sperm DNA fragmentation rate will be ≥ 23% compared to the placebo treated group to validate the efficacy hypothesis. The measurement of the sperm DNA fragmentation rate is performed by TUNEL (Terminal deoxynucleotidyl transferase dUTP (deoxyuridine triphosphate) nick end labeling) method. The secondary objectives are the evaluation of classical sperm parameters (spermiogram, spermocytogram), sperm morphology score, chromatin decondensation rate, sperm red/ox potential, differential expression of 11 specific genes involved in spermatogenesis and/or at different stages of the fertilisation process (AURKA, CCDC60, CCDC88B, etc.)).
[Results to be reported later]
- Conditions
- Male Infertility
- Being tested
- Isitol®, Placebo
- Keywords
- Spermatozoa, DNA Fragmentation, Chromatin Condensation, Food supplement, TUNEL
- Medical subject headings
- Infertility, Male
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Isitol®Dietary supplement
1 sachet of Isitol® (2,1g) contains :
- 1000 mg of myo-inositol ;
- 300 mg of N-acetyl-cystein ;
- 48.5 mg of zinc citrate (equivalent zinc pure element : 15 mg) ;
- 35 mg of D-a-tocopherol (equivalent vitamin E pure element : 12 mg) ;
- 16 mg of vitamin B3 ;
- 1.8 mg of pyridoxin hydrochloride (equivalent vitamin B6 pure element : 1.4 mg) ;
- 1.4 mg of vitamin B2 ;
- 0.37 mg of (6S)-5-methyltetrahydrofolic acid, glucosamine salt (equivalent vitamin B9 pure element : 0.2 mg).
Sachets are packaged in box of 30.
PlaceboOther
1 sachet of placebo (2,1g) contains :
- 1765.1 of maltodextrin ;
- 300 mg of magnesium carbonate ;
- 40 mg of citric acid ;
- 5.3 mg of beta-carotene ;
- 2.16 mg of silicon dioxide ;
- 1.44 mg of sucralose.
Sachets are packaged in box of 30.
| Study group | Role | What they receive |
|---|---|---|
| Isitol® (Food supplement treated group) | Experimental | 36 eligible males between 20 and 45 yo. (included limits) will take 1 sachet of Isitol® per day during 16 (± 2) weeks. The sachet of powder is to dissolve in a glass of water or directly in mouth.
1 sachet of Isitol® (2,1g) contains 1000 mg of myo-inositol, 300 mg of N-acetyl-cysteine, 150 % of the Nutritional Reference Values (NRV) in zinc and 100 % of the NRV: in vitamins B2, B3, B6, B9 and E. Receives: Dietary Supplement: Isitol® |
| Placebo treated group | Placebo comparator | 36 eligible males between 20 and 45 yo. (included limits) will take 1 sachet of placebo per day during 16 (± 2) weeks. The sachet of powder is to dissolve in a glass of water or directly in mouth.
1 sachet of placebo (2,1g) contains only excipients used in Isitol® and excipients to get similar organoleptic aspect (maltodextrin, sucralose, silicon dioxide, magnesium carbonate, citric acid and beta-carotene). Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline sperm DNA fragmentation rate at 4 months
Sperm DNA fragmentation rate is assessed by the TUNEL (Terminal deoxynucleotidyl transferase dUTP nick end labeling) method. This method is based on the attachment of fluorochrome-coupled biotin-deoxyuridine (dUDP) complexes to the 3'OH ends of possible DNA fragments. The binding of the complexes to the DNA is catalysed by the enzyme Terminal-deoxynucleotidyltransferase. Spermatozoa with fragmented DNA are detected and their percentage measured directly by in-situ confocal fluorescence microscopy.
Measured: Sperm DNA fragmentation rate is measured at first Visit (V0) and at the last Visit (V2) after 16 +/- 2 weeks of treatment with Isitol or placebo
Secondary outcomes (11)
Change from baseline nuclear chromatin decondensation of spermatozoa at 4 months
Nuclear chromatin decondensation is assessed by the aniline blue method and expressed in percentage (%).
Measured: Nuclear chromatin decondensation is measured at first Visit (V0) and at the last Visit (V2) after 16 +/- 2 weeks of treatment with Isitol or placebo
Change from baseline semen volume at 4 months
Semen volume is expressed in mL.
Measured: Semen volume is mesured at first Visit (V0) and at the last Visit (V2) after 16 +/- 2 weeks of treatment with Isitol or placebo
Change from baseline semen pH at 4 months
Semen pH is expressed without unit, the values ranging from 1 to 14.
Measured: Semen pH is measured at first Visit (V0) and at the last Visit (V2) after 16 +/- 2 weeks of treatment with Isitol or placebo
Change from baseline semen liquefaction time at 4 months
When the sample is collected it presents a state of coagulation, and must be liquefied to proceed to its study. Semen liquefaction time is expressed in minutes.
Measured: Semen liquefaction time is mesured at first Visit (V0) and at the last Visit (V2) after 16 +/- 2 weeks of treatment with Isitol or placebo
Change from baseline spermiogram total spermatozoa, round cells and polynuclear cells count at 4 months
The total number of each cell type is counted and expressed in millions (10^6)/ejaculate. The relative concentrations in spermatozoa, round cells and polynuclear cells are obtained after weighting by sample volume and expressed in millions (10^6)/mL.
Measured: Cells counts are realised at first Visit (V0) and at the last Visit (V2) after 16 +/- 2 weeks of treatment with Isitol or placebo
Change from baseline spermiogram viability and mobility count at 4 months
Viability and mobility of spermatozoa is evaluated and expressed in percentage (%).
Measured: Viability and mobility are are evaluated at first Visit (V0) and at the last Visit (V2) after 16 +/- 2 weeks of treatment with Isitol or placebo
Change from baseline spermocytogram abnormalities count at 4 months
Spermocytogram is a microscopic analysis of the ejaculate in order to evaluate the number of sperm morphological abnormalities on each part of the spermatozoon (head, middle piece, flagellum).
Measured: Spermocytogram abnormalities count is realised at first Visit (V0) and at the last Visit (V2) after 16 +/- 2 weeks of treatment with Isitol or placebo
Change from baseline spermocytogram isolated flagella and of spermatozoa in cell lysis phase numbers at 4 months
Isolated flagella and spermatozoa in cell lysis phase are counted and expressed in percentage (%).
Measured: Spermocytogram isolated flagella and of spermatozoa in cell lysis phase count is realised at first Visit (V0) and at the last Visit (V2) after 16 +/- 2 weeks of treatment with Isitol or placebo
Change from baseline sperm morphology scoring at 4 months
The score of sperm morphology is assessed according to Cassuto-Barak classification. Spermatozoa are classified into 3 categories (I,II,III) according to the number and/or localisation of morphological abnormalities. The results are expressed in percentage (%) of each class I, II and III.
Measured: Sperm morphology scoring is realised at first Visit (V0) and at the last Visit (V2) after 16 +/- 2 weeks of treatment with Isitol or placebo
Change from baseline semen Red/ox potential at 4 months
The measurement of the semen Red/Ox potential is performed using the MiOXSYS measuring device (Aytu Bioscience 373 Inverness Parkway - Englewood, CO 80112 USA). This device measures the static oxidation reduction potential (sORP) of a biological sample, in this case human semen. The sORP has been described as an integrated measure of the balance between total oxidative activity (including reactive oxygen species) and total reducing activity. Therefore, the level of oxidative stress (increase in oxidative species and/or decrease in antioxidant activity) can be quantified electrically using an sORP sensor. The result is indicated in mV and the increase in sORP is correlated with an increase in the level of oxidative stress. The relative sORP is obtained after weighting by concentration in spermatozoa and expressed in mV/millions (10^6)/mL.
Measured: Red/ox potential measurement is realised at first Visit (V0) and at the last Visit (V2) after 16 +/- 2 weeks of treatment with Isitol or placebo
Change from baseline genes expression (AURKA, CCDC60, CCDC88B, CFAP46, HDAC4, CACNA1C, CACNA1H, CARHSP1, DNAH2, HMGB4, SPATA18) at 4 months
The expression level of the AURKA, CCDC60, CCDC88B, CFAP46, HDAC4, CACNA1C, CACNA1H, CARHSP1, DNAH2, HMGB4 and SPATA18 genes in spermatozoa will be measured using an RT-qPCR (Reverse transcriptase quantitative polymerase chain reaction) technique with specific primer pairs. The different mRNAs will be extracted from spermatozoa using an extraction kit (miRNeasy Kit (QIAGEN)). Using primers specific to each of the genes studied, the mRNAs of these genes of interest will be back-transcribed into complementary DNA and then amplified according to a determined number of replication cycles (45 cycles). By measuring the fluorescence intensity in each of the cells, the concentration of complementary DNA is calculated. The relative expression of these different genes is obtained after normalisation using two ubiquitous and constant expression genes.
Measured: Genes expression measurement is realised at first Visit (V0) and at the last Visit (V2) after 16 +/- 2 weeks of treatment with Isitol or placebo
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2021
- Study start7 Jul 2021
- Primary completionApr 2026 (estimated)
- Study completionJul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Male InfertilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The randomization scheme is 1 : 1 (treated with food supplement vs placebo). The different treatments (2) have been anonymized, a randomization list is used to assign an anonymous box number (5 random numbers) according to the patient's order of inclusion. Only the promoter is aware of the assignment of the randomization number with which treatment it corresponds.
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- GYNOV
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Laboratoire Drouot
- Responsible party
- Sponsor-investigator, GYNOV, GYNOV
- Investigators
- Nino-Guy Cassuto, PharmD, Principal investigator, Laboratoire Drouot
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04959864
- Sponsor's protocol ID
- 2020-A02402-37
- Status last verified
- Aug 2025
- First submitted
- 23 Jun 2021
- Last updated
- 22 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double-Blind Randomized Controlled Trial Evaluating the Efficacy of the Food Supplement Isitol® Versus Placebo on the Rate of Abnormal Sperm DNA Fragmentation
- ClinicalTrials.gov ID
- NCT04959864
- Acronym / sponsor ID
- 2020-A02402-37
- Conditions
- Male Infertility
- Keywords
- Spermatozoa, DNA Fragmentation, Chromatin Condensation, Food supplement, TUNEL
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- GYNOVIndustry (pharma, biotech, devices)
- Collaborators
- Laboratoire Drouot
- Study start
- 7 Jul 2021 (actual)
- Primary completion
- Apr 2026 (estimated)
- Study completion
- Jul 2026 (estimated)
- First posted
- 13 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In industrialised countries, it is estimated that about 15% of couples who wish to have a child are currently facing infertility problems, of which, in half of the cases, an anomaly in sperm quality or at least a factor of male origin is identified. The evaluation of sperm quality in males is based, for the most part, on the micro and macroscopic examination of various parameters (concentration, motility, physical abnormalities of the spermatozoa, etc.). Nevertheless, an increasing number of scientific studies have shown that the quality of sperm DNA, and in particular its fragmentation rate, is also associated with a lower fertilisation rate. The integrity of sperm DNA may be affected by an imbalance in the Red/Ox balance leading to uncompensated oxidative stress, and could be restored or improved by dietary hygiene measures and the consumption of specific dietary products. The ISITOL clinical study aims to evaluate the efficacy of a dietary supplement specifically formulated to target the various issues associated with male infertility, and in particular to contribute to the improvement of the sperm DNA fragmentation rate. The efficacy of the dietary supplement Isitol® (GYNOV SAS) on sperm DNA fragmentation rate and other secondary parameters is being evaluated through a single-centre, prospective, randomised, double-blind, interventional vs. placebo clinical study being conducted in France at Laboratoire Drouot (21 Rue Drouot - 75009 Paris - France) and led by Dr. Nino-Guy Cassuto. A total of 72 men aged between 20 and 45 years, with sperm DNA fragmentation rate ≥ 30% and with negative semen culture are recruited. The recruited patients were randomized in a 1:1 scheme into 2 groups (Isitol® treated vs placebo treated).
[Results to be reported later]
Detailed description
Infertility is generally defined as a partner's failure to conceive after at least 12 months off contraception and is steadily increasing worldwide. In industrialised countries, it is estimated that around 15% of couples who wish to have a child are now facing it, and in half of the cases, an abnormality in sperm quality or at least a male factor is identified.
In males, the measurement of male fertility is mainly based on analyses that assess sperm quality macroscopically (spermiogram, spermocytogram) by evaluating the number, morphology, motility, presence of abnormalities, etc. These indicators are still considered to be the preferred indicators for assessing male fertility.
Nevertheless, since the mid-2000s, numerous in vitro and in vivo studies in humans and animals have shown that the integrity of sperm DNA, assessed by measuring the rate of DNA fragmentation and chromatin decondensation in spermatozoa, could be a relevant parameter in the etiology of male infertility. Furthermore, it has been observed that the rate of sperm DNA fragmentation is inversely correlated with pregnancy rate, success rate of assisted reproductive techniques and embryo quality.
The major identified cause of direct damage to DNA molecules and their possible fragmentation, but also to proteins and cell membranes in spermatozoa is oxidative stress. Unreduced Reactive oxygen species produced in the mitochondria-rich midpiece in excess are susceptible to damage the DNA in the sperm head. Several exogenous factors such as exposure to toxins, smoking, alcohol or unbalanced diet are also associated with promoting oxidative stress.
A fragmentation rate higher than 30% is considered high, it is indicative of altered chromatin and especially associated with a low probability of conceiving naturally or through in vitro techniques.
To resolve this problem and improve the process of spermatogenesis and fertilisation, it is relevant to evaluate the effectiveness of a food supplement (Isitol®), manufactured and marketed by the company Gynov SAS (2B Rue Sauteyron - 33000 Bordeaux - France), which provides myo-inositol and a complex with antioxidant properties based on N-acetyl-cysteine, group B vitamins (B2, B3, B6, B9), vitamin E and zinc.
In addition to providing the nutrients that contribute to a better management of the reactive oxygen species, the food supplement provides myo-inositol, which is essential for the functioning of a wide range of cellular functions. This molecule, related to glucose, is produced in the testis, mainly by Sertoli cells, and is excreted into the seminiferous tubules as a gradient. This gradient contributes to sperm maturation by reducing sperm viscosity and increasing sperm motility. Numerous studies evaluating the impact of myo-inositol have shown a significant improvement in sperm parameters (concentration, motility, morphology) and in particular in the rate of sperm DNA fragmentation.
In order to evaluate the efficacy of this dietary supplement, a single-centre, prospective, randomised, double-blind, interventional vs. placebo clinical study was set up in France at Laboratoire Drouot (21 Rue Drouot - 75009 Paris - France) and directed by Dr. Nino-Guy Cassuto. A total of 72 men aged between 20 and 45 years, with sperm DNA fragmentation rate ≥ 30% and with negative semen culture are recruited. The recruited patients were randomised in a 1:1 design into 2 groups (Isitol® treated vs placebo treated).
The primary hypothesis is that after 16 (± 2) weeks of treatment with the dietary supplement, the expected decrease in sperm DNA fragmentation rate will be ≥ 23% compared to the placebo treated group to validate the efficacy hypothesis. The measurement of the sperm DNA fragmentation rate is performed by TUNEL (Terminal deoxynucleotidyl transferase dUTP (deoxyuridine triphosphate) nick end labeling) method. The secondary objectives are the evaluation of classical sperm parameters (spermiogram, spermocytogram), sperm morphology score, chromatin decondensation rate, sperm red/ox potential, differential expression of 11 specific genes involved in spermatogenesis and/or at different stages of the fertilisation process (AURKA, CCDC60, CCDC88B, etc.)).
[Results to be reported later]
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- The randomization scheme is 1 : 1 (treated with food supplement vs placebo). The different treatments (2) have been anonymized, a randomization list is used to assign an anonymous box number (5 random numbers) according to the patient's order of inclusion. Only the promoter is aware of the assignment of the randomization number with which treatment it corresponds.
| Arm | Type | Receives |
|---|---|---|
| Isitol® (Food supplement treated group) | Experimental | Dietary Supplement: Isitol®36 eligible males between 20 and 45 yo. (included limits) will take 1 sachet of Isitol® per day during 16 (± 2) weeks. The sachet of powder is to dissolve in a glass of water or directly in mouth. 1 sachet of Isitol® (2,1g) contains 1000 mg of myo-inositol, 300 mg of N-acetyl-cysteine, 150 % of the Nutritional Reference Values (NRV) in zinc and 100 % of the NRV: in vitamins B2, B3, B6, B9 and E. |
| Placebo treated group | Placebo comparator | Other: Placebo36 eligible males between 20 and 45 yo. (included limits) will take 1 sachet of placebo per day during 16 (± 2) weeks. The sachet of powder is to dissolve in a glass of water or directly in mouth. 1 sachet of placebo (2,1g) contains only excipients used in Isitol® and excipients to get similar organoleptic aspect (maltodextrin, sucralose, silicon dioxide, magnesium carbonate, citric acid and beta-carotene). |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Sperm DNA fragmentation rate ≥ 30 %
Key exclusion criteria (1 listed)
- Positive semen culture
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Isitol®1 sachet of Isitol® (2,1g) contains : * 1000 mg of myo-inositol ; * 300 mg of N-acetyl-cystein ; * 48.5 mg of zinc citrate (equivalent zinc pure element : 15 mg) ; * 35 mg of D-a-tocopherol (equivalent vitamin E pure element : 12 mg) ; * 16 mg of vitamin B3 ; * 1.8 mg of pyridoxin hydrochloride (equivalent vitamin B6 pure element : 1.4 mg) ; * 1.4 mg of vitamin B2 ; * 0.37 mg of (6S)-5-methyltetrahydrofolic acid, glucosamine salt (equivalent vitamin B9 pure element : 0.2 mg). Sachets are packaged in box of 30. | Dietary supplement | Isitol® (Food supplement treated group) |
| Placebo1 sachet of placebo (2,1g) contains : * 1765.1 of maltodextrin ; * 300 mg of magnesium carbonate ; * 40 mg of citric acid ; * 5.3 mg of beta-carotene ; * 2.16 mg of silicon dioxide ; * 1.44 mg of sucralose. Sachets are packaged in box of 30. | Other | Placebo treated group |
Primary outcome
Change from baseline sperm DNA fragmentation rate at 4 months
Time frame: Sperm DNA fragmentation rate is measured at first Visit (V0) and at the last Visit (V2) after 16 +/- 2 weeks of treatment with Isitol or placebo
Sperm DNA fragmentation rate is assessed by the TUNEL (Terminal deoxynucleotidyl transferase dUTP nick end labeling) method. This method is based on the attachment of fluorochrome-coupled biotin-deoxyuridine (dUDP) complexes to the 3'OH ends of possible DNA fragments. The binding of the complexes to the DNA is catalysed by the enzyme Terminal-deoxynucleotidyltransferase. Spermatozoa with fragmented DNA are detected and their percentage measured directly by in-situ confocal fluorescence microscopy.
11 secondary outcomes
Change from baseline nuclear chromatin decondensation of spermatozoa at 4 months
Time frame: Nuclear chromatin decondensation is measured at first Visit (V0) and at the last Visit (V2) after 16 +/- 2 weeks of treatment with Isitol or placebo
Change from baseline semen volume at 4 months
Time frame: Semen volume is mesured at first Visit (V0) and at the last Visit (V2) after 16 +/- 2 weeks of treatment with Isitol or placebo
Change from baseline semen pH at 4 months
Time frame: Semen pH is measured at first Visit (V0) and at the last Visit (V2) after 16 +/- 2 weeks of treatment with Isitol or placebo
Change from baseline semen liquefaction time at 4 months
Time frame: Semen liquefaction time is mesured at first Visit (V0) and at the last Visit (V2) after 16 +/- 2 weeks of treatment with Isitol or placebo
Change from baseline spermiogram total spermatozoa, round cells and polynuclear cells count at 4 months
Time frame: Cells counts are realised at first Visit (V0) and at the last Visit (V2) after 16 +/- 2 weeks of treatment with Isitol or placebo
Change from baseline spermiogram viability and mobility count at 4 months
Time frame: Viability and mobility are are evaluated at first Visit (V0) and at the last Visit (V2) after 16 +/- 2 weeks of treatment with Isitol or placebo
Change from baseline spermocytogram abnormalities count at 4 months
Time frame: Spermocytogram abnormalities count is realised at first Visit (V0) and at the last Visit (V2) after 16 +/- 2 weeks of treatment with Isitol or placebo
Change from baseline spermocytogram isolated flagella and of spermatozoa in cell lysis phase numbers at 4 months
Time frame: Spermocytogram isolated flagella and of spermatozoa in cell lysis phase count is realised at first Visit (V0) and at the last Visit (V2) after 16 +/- 2 weeks of treatment with Isitol or placebo
Change from baseline sperm morphology scoring at 4 months
Time frame: Sperm morphology scoring is realised at first Visit (V0) and at the last Visit (V2) after 16 +/- 2 weeks of treatment with Isitol or placebo
Change from baseline semen Red/ox potential at 4 months
Time frame: Red/ox potential measurement is realised at first Visit (V0) and at the last Visit (V2) after 16 +/- 2 weeks of treatment with Isitol or placebo
Change from baseline genes expression (AURKA, CCDC60, CCDC88B, CFAP46, HDAC4, CACNA1C, CACNA1H, CARHSP1, DNAH2, HMGB4, SPATA18) at 4 months
Time frame: Genes expression measurement is realised at first Visit (V0) and at the last Visit (V2) after 16 +/- 2 weeks of treatment with Isitol or placebo
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Nino-Guy Cassuto, PharmD principal investigator
Laboratoire Drouot
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Isitol® in people with Male Infertility, run by GYNOV at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pierre-Yves Mousset, MD (616310400 ext. +33, py.mousset@gynov.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline sperm DNA fragmentation rate at 4 months (time frame: Sperm DNA fragmentation rate is measured at first Visit (V0) and at the last Visit (V2) after 16 +/- 2 weeks of treatment with Isitol or placebo). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2025.