Double-Blind Randomized Controlled Trial Evaluating the Efficacy of the Food Supplement Isitol® Versus Placebo on the Rate of Abnormal Sperm DNA Fragmentation

Status: Recruiting
Location: See location...
Intervention Type: Dietary supplement, Other
Study Type: Interventional
Study Phase: Not Applicable
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). \[Results to be reported later\]

Eligibility
Participation Requirements
Sex: Male
Minimum Age: 20
Maximum Age: 45
Healthy Volunteers: t
View:

• Sperm DNA fragmentation rate ≥ 30 %

Locations
Other Locations
France
Laboratoire Drouot
RECRUITING
Paris
Contact Information
Primary
Pierre-Yves Mousset, MD
py.mousset@gynov.com
616310400
Backup
Axel Dries, Master
a.dries@gynov.com
636630660
Time Frame
Start Date: 2021-07-07
Estimated Completion Date: 2026-07
Participants
Target number of participants: 72
Treatments
Experimental: Isitol® (Food supplement treated group)
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_comparator: Placebo treated group
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).
Related Therapeutic Areas
Sponsors
Collaborators: Laboratoire Drouot
Leads: GYNOV

This content was sourced from clinicaltrials.gov