Evaluating a dietary supplement for improving sperm DNA quality

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.