Actively Recruiting
Double-Blind Randomized Controlled Trial Evaluating the Efficacy of the Food Supplement Isitol4 Versus Placebo on Abnormal Sperm DNA Fragmentation Rate
Led by GYNOV · Updated on 2025-08-22
72
Participants Needed
1
Research Sites
13 weeks
Total Duration
On this page
Sponsors
G
GYNOV
Lead Sponsor
L
Laboratoire Drouot
Collaborating Sponsor
AI-Summary
What this Trial Is About
Male infertility affects about 15% of couples in industrialized countries, with male factors like sperm quality issues contributing to half of these cases. Researchers are studying the dietary supplement Isitol4 (made by GYNOV SAS) to see if it can improve sperm DNA fragmentation, a key factor linked to fertility. This interventional, double-blind, randomized clinical trial compares Isitol4 to a placebo in men aged 20 to 45 with high sperm DNA fragmentation rates. Participants are randomly assigned to one of two groups: one group takes a daily sachet of Isitol4 containing myo-inositol, N-acetyl-cysteine, zinc, and vitamins for 16 weeks, while the other group receives a placebo sachet with similar appearance and taste. The study aims to measure changes in sperm DNA fragmentation and secondary sperm quality parameters after the treatment period. During the study, sperm DNA fragmentation and other sperm characteristics are measured at the start and after about 16 weeks of treatment. Researchers also assess sperm chromatin decondensation, semen volume, pH, liquefaction time, sperm counts, morphology, red/ox potential, and gene expression related to sperm production. The study includes safety monitoring and aims to provide detailed information about the supplement's impact on male fertility over the treatment duration.
CONDITIONS
Brief Title
Efficacy Study of a Food Supplement With Myo-inositol, N-Acetyl-Cystein, Zinc and Vitamins on Sperm DNA Fragmentation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male patient volunteers aged 20 to 45 years (limits included)
- Socially insured patient receiving benefits from the French Social Security's health branch
- Sperm DNA fragmentation rate 2030%
- Negative semen culture
- Not currently consuming dietary supplements
- Body Mass Index (BMI) between 19 and 29 inclusive
You will not qualify if you...
- Infertility of infectious or genetic origin
- Pathology requiring concomitant medical treatment
- Consumption of dietary supplements during the previous 3 months and during the study
- Smoking 5 or more cigarettes per day
- Alcohol consumption of 10 or more drinks per week
- Occupation with risk of exposure to carcinogenic, mutagenic, or toxic reproductive agents
- Unable to give consent
- Minors, protected adults, or vulnerable persons
- Currently participating in another clinical research study
- Positive semen culture
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 16 ± 2 weeks
Participants take 1 sachet of either the food supplement Isitol® or a placebo daily to evaluate the effect on sperm DNA fragmentation and related sperm parameters.
2 visits (baseline and end of treatment, both in-person)
Trial Site Locations
Total: 1 location
1
Laboratoire Drouot
Paris, France, 75009
Actively Recruiting
Research Team
P
Pierre-Yves Mousset, MD
A
Axel Dries, Master
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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