Status:
RECRUITING
Oxidative Stress and Male Infertility.
Lead Sponsor:
IRCCS San Raffaele
Conditions:
Male Infertility
Eligibility:
MALE
18-50 years
Brief Summary
Study Aims: To evaluate the impact of oxidative and nitrosative stress, as well as DNA methylation, on male reproductive health. This is achieved by analyzing urinary biomarkers: 8-oxoGua, 8-oxoGuo, ...
Detailed Description
Infertility affects approximately 15% of couples in their reproductive age. Male factors contribute to 45-50% of infertility cases, with 7% of the global male population diagnosed as infertile. Oxidat...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
June 27 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
June 30 2025
Estimated Enrollment :
800 Patients enrolled
Trial Details
Trial ID
NCT06210568
Start Date
June 27 2023
End Date
June 30 2025
Last Update
January 18 2024
Active Locations (1)
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1
IRCCS San Raffaele
Milan, MI, Italy, 20132