Evaluating the impact of oxidative stress on male infertility
Role of Oxidative Stress in Male Infertility: an Observational Case-control Study
This study is trying to see if certain chemical changes in the body are linked to infertility in men by comparing those who are struggling to conceive with those who are fertile.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 800 (estimated) |
| Ages | 18 Years to 50 Years |
| Sex | Male |
| Sponsor | IRCCS San Raffaele Academic / other |
| Locations | 1 site (Milan, MI) |
| Trial ID | NCT06210568 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the effects of oxidative and nitrosative stress, along with DNA methylation, on male reproductive health. It involves a prospective case-control design comparing infertile males diagnosed with couple infertility to fertile male volunteers. Urinary biomarkers such as 8-oxoGua and 5-methylcytidine will be analyzed to understand their role in male infertility and implications for assisted reproductive techniques. The study seeks to provide insights into the biochemical factors contributing to male infertility.
Who should consider this trial
Good fit: Ideal candidates include males aged 18 to 50 with a diagnosis of infertility due to no conception for over 12 months.
Not a fit: Patients with clear diagnoses of infertility due to established clinical evidence or those unable to produce a useful semen sample may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved understanding and potential interventions for male infertility.
How similar studies have performed: Other studies have indicated the significance of oxidative stress in male infertility, suggesting that this approach is supported by existing research.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Infertile Male Patients: a diagnosis of couple infertility due to no conception for over 12 months (as per the access criteria for Assisted Reproductive Technology defined by law 40/2004), aged between 18 and 50 years, and having signed informed consent. Fertile Males:Inclusion criteria are having fathered at least one child, aged between 18 and 50 years, and having signed informed consent. Exclusion Criteria: Infertile Male Patients: Exclusion criteria include a clear diagnosis of infertility due to established clinical evidence (evident endocrinological disorders, previous testicular trauma, vasectomy, epididymitis, orchitis, cryptorchidism, varicocele), inability to produce a useful semen sample for analysis (azoospermia), past diseases that involved radiological therapies in the genital area, and creatinuria levels outside the WHO normal range (0.3-3 grams). Fertile Males:conception using assisted reproductive techniques and a waiting time of more than 12 months for conception, as well as creatinuria levels outside the WHO normal range (0.3-3 grams).
Where this trial is running
Milan, MI
- IRCCS San Raffaele — Milan, Mi, Italy (Recruiting)
Study contacts
- Principal investigator: Luca Pagliardini — IRCCS San Raffaele
- Study coordinator: Luca Pagliardini
- Email: pagliardini.luca@hsr.it
- Phone: +39 02 2643 4834
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.