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:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-03-26 @ 3:17 PM
NCT ID:
NCT07330869
Eligibility Criteria:
Inclusion Criteria:
* Male sex, age between 18 and 50 years;
* Scheduled for elective cardiac surgery (valve replacement, valve repair, or other cardiac procedures) with or without indication to Warfarin therapy;
* Ability and willingness to provide semen samples at scheduled timepoints;
* No previous diagnosis of male infertility documented in medical records;
* Signed informed consent.
Exclusion Criteria:
* Known severe testicular pathology (for example, untreated high-grade varicocele, history of cryptorchidism, orchiectomy, testicular tumors);
* Prior chemotherapy or pelvic radiotherapy;
* Current or recent use of anabolic steroids or other drugs known to strongly impair spermatogenesis;
* Known endocrine disorders affecting spermatogenesis (for example, untreated hypogonadism, hyperprolactinaemia, severe thyroid disease);
* Active genitourinary infection at the time of evaluation;
* Life expectancy less than 12 months or clinical conditions preventing adherence to follow-up.
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Maximum Age:
50 Years
Study:
NCT07330869
Study Brief:
Protocol Section:
NCT07330869