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:
2025-12-25 @ 2:24 AM
Ignite Modification Date:
2025-12-25 @ 2:24 AM
NCT ID:
NCT04213534
Eligibility Criteria:
Inclusion Criteria:
1. Male, aged 18 \~45 years old;
2. In accordance with the gout classification criteria of the American Rheumatic Society in 1977 or ACR/EULAR (European Alliance against Rheumatism) in 2015 ;
3. Willing to receive uric acid-lowering drugs regularly for at least 3 months;
4. No drugs affecting sperm quality were taken within 3 months before screening.
5. Sign the informed consent form.
Exclusion Criteria:
1. Patients who have a pregnancy plan during the trial;
2. Patients with severe heart, liver, kidney and other important organs, blood and endocrine system diseases, the evaluation criteria are as follows:
1. Heart disease: patients with a history of heart disease such as decompensated cardiac insufficiency, refractory hypertension or coronary heart disease;
2. Liver function: alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) ≥ 2 times the upper limit of normal reference value (ULN);
3. Renal function: complicated with renal tubule and/or renal interstitial lesions, or renal insufficiency: serum creatinine≥ULN or glomerular filtration rate (eGFR) \<60ml/min/1.73m2;
3. leukocyte (WBC) count \<3 × 109/L and/or hemoglobin (Hb) \<100g/L and/or platelet (PLT) count \<80 × 109/L;
4. Other serious diseases, such as tumors, etc;
5. Those who are unable to cooperate with the treatment of mental illness or other reasons;
6. Allergic constitution or multi-drug allergy;
7. Those who are known to be allergic or intolerant to uric acid-lowering drugs in the trial;
8. Chromosome abnormality or deletion of AZF region of Y chromosome;
9. Previous history of orchitis, epididymitis, mumps or varicocele affecting sperm quality;
10. Positive semen bacterial culture, or Chlamydia trachomatis, Ureaplasma Urealyticum and Mycoplasma hominis;
11. Those who have a history of exposure to high temperature, chemistry, physics or toxicants in the past year;
12. Those who undergo X-ray or CT examination in the past 3 months and during the period of enrollment;
13. Patients with other systemic diseases who are being treated with other drugs that may affect semen quality.
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Maximum Age:
45 Years
Study:
NCT04213534
Study Brief:
Protocol Section:
NCT04213534