Efficacy Study of a Food Supplement With Myo-inositol, N-Acetyl-Cystein, Zinc and Vitamins on Sperm DNA Fragmentation

NCT04959864 | Recruiting

• 1 other identifier: 2020-A02402-37
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief 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. 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). \[Results to be reported later\]

Conditions

Male Infertility

Keywords

Spermatozoa; DNA Fragmentation; Chromatin Condensation; Food supplement; TUNEL

Outcome Measures

Primary Outcomes (1)

• 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.

  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 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 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 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

  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

  Cells counts are realised at first Visit (V0) and at the last Visit (V2) after 16 +/- 2 weeks of treatment with Isitol or placebo

Study Arms (2)

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.

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).

Other: Placebo

Interventions

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.

Isitol® (Food supplement treated group)

Placebo OTHER

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.

Placebo treated group

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Sperm DNA fragmentation rate ≥ 30 %

You may not qualify if:

• Positive semen culture

Sponsors & Collaborators

• GYNOV: lead
• Laboratoire Drouot: collaborator

Study Sites (1)

Laboratoire Drouot

Paris, 75009, France

RECRUITING

MeSH Terms

Conditions

Infertility, Male

Condition Hierarchy (Ancestors)

Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Infertility; Male Urogenital Diseases

Study Officials

• Nino-Guy Cassuto, PharmD

  Laboratoire Drouot

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Pierre-Yves Mousset, MD

CONTACT

616310400; py.mousset@gynov.com

Axel Dries, Master

CONTACT

636630660; a.dries@gynov.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chief Executive Officer

Model Details: 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.

Study Record Dates

• First Submitted: June 23, 2021
• First Posted: July 13, 2021
• Study Start: July 7, 2021
• Primary Completion: April 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: August 22, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)