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Search / Trial NCT06210568

Oxidative Stress and Male Infertility.

Launched by IRCCS SAN RAFFAELE · Jan 8, 2024

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

ClinConnect Summary

This clinical trial is studying the relationship between oxidative stress and male infertility. Oxidative stress happens when there are too many harmful molecules in the body, which can affect reproductive health. The researchers are looking at specific markers in urine from both infertile men (who have been trying to conceive for over a year without success) and fertile men (who have fathered at least one child). By comparing these two groups, the study aims to understand how oxidative stress might play a role in male infertility and how this knowledge could help in assisted reproductive techniques.

To be eligible for the study, infertile men need to be between 18 and 50 years old and willing to provide consent. They cannot have certain medical conditions that are known to cause infertility. Fertile men also need to be in the same age range and must have successfully fathered a child. Participants will provide urine samples for analysis, and the findings may help improve treatments for men facing infertility challenges. If you or someone you know is interested in participating, be sure to discuss it with a healthcare provider for more information.

Gender

MALE

Eligibility 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).

About Irccs San Raffaele

IRCCS San Raffaele is a prestigious research hospital and clinical trial sponsor based in Milan, Italy, renowned for its commitment to advancing medical science through innovative research and high-quality patient care. As an Institute for Research and Healthcare, it specializes in a wide range of therapeutic areas, including oncology, neurology, and cardiology, and is dedicated to translating scientific discoveries into effective clinical practices. With a multidisciplinary team of experts and state-of-the-art facilities, IRCCS San Raffaele plays a pivotal role in conducting rigorous clinical trials that contribute to the development of novel treatments and improve patient outcomes globally.

Locations

Milan, , Italy

Patients applied

0 patients applied

Trial Officials

Enrico Papaleo

Study Director

IRCCS San Raffaele

Luca Pagliardini

Principal Investigator

IRCCS San Raffaele

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported