Evaluating a dietary supplement for improving sperm DNA quality
Double-Blind Randomized Controlled Trial Evaluating the Efficacy of the Food Supplement Isitol® Versus Placebo on the Rate of Abnormal Sperm DNA Fragmentation
This study is testing a dietary supplement to see if it can improve sperm DNA quality in men aged 20 to 45 who are struggling with infertility.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 72 (estimated) |
| Ages | 20 Years to 45 Years |
| Sex | Male |
| Sponsor | Gynov Industry-sponsored |
| Locations | 1 site (Paris) |
| Trial ID | NCT04959864 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the efficacy of a dietary supplement containing Myo-inositol, N-Acetyl-Cystein, Zinc, and vitamins on reducing sperm DNA fragmentation in men experiencing infertility. The study focuses on male patients aged 20 to 45 who have a sperm DNA fragmentation rate of 30% or higher. Participants will be randomly assigned to receive either the supplement or a placebo, with the aim of assessing improvements in sperm quality and potential impacts on fertility. The trial seeks to address the growing concern of male infertility linked to oxidative stress and DNA integrity.
Who should consider this trial
Good fit: Ideal candidates for this study are male patients aged 20 to 45 with a sperm DNA fragmentation rate of 30% or higher.
Not a fit: Patients with infertility due to infectious or genetic causes, or those requiring concurrent medical treatment, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a novel dietary intervention to improve sperm quality and enhance fertility outcomes for men facing infertility issues.
How similar studies have performed: While the approach of using dietary supplements for improving sperm quality is gaining interest, this specific combination has not been widely tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Selection Criteria: * Male patient volunteers aged 20 to 45 years (limits included); * Socially insured patient receiving benefits from the French Social Security's health branch Non-Selection Criteria: * Patients suffering from infertility of infectious or genetic origin, or from a pathology requiring concomitant medical treatment; * Consumption of dietary supplements during the previous 3 months and during the course of the study; * Smoking ≥ 5 cigarettes/day; * Alcoholism ≥ 10 drinks (alcohol standard)/week ; * Body Mass Index (BMI) not between \[19 and 29\] (inclusive). * Occupation at risk of exposure to carcinogenic, mutagenic and toxic agents for reproduction defined according to articles R.4412-2 2°, R.4412-3 and R.4412-60 of the French Labour Code; * Patient unable to give consent; * Minors and protected adults, vulnerable persons; * Patient participating in another clinical research study Inclusion Criteria: * Sperm DNA fragmentation rate ≥ 30 % Exclusion Criteria: * Positive semen culture
Where this trial is running
Paris
- Laboratoire Drouot — Paris, France (Recruiting)
Study contacts
- Principal investigator: Nino-Guy Cassuto, PharmD — Laboratoire Drouot
- Study coordinator: Pierre-Yves Mousset, MD
- Email: py.mousset@gynov.com
- Phone: 616310400
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.