Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:34 PM
Ignite Modification Date:
2025-12-24 @ 5:34 PM
NCT ID:
NCT06210568
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).
Sex:
MALE
Minimum Age:
18 Years
Maximum Age:
50 Years
Study:
NCT06210568
Study Brief:
Protocol Section:
NCT06210568