Clinical trial: The Influence of Urate-lowering Therapy on Sperm Quality of Male Gouty Patients：A Prospective Cohort Study (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. When entering the group, the semen routine did not reach the standard stipulated in
             the WHO Manual for Laboratory examination of Human semen and sperm-Cervical mucus
             interaction (Fifth Edition), that is, semen volume>1.5ml, pH>7.2, sperm
             density>15x106/ ml, sperm motility (percentage of forward motile sperm, PR)>32%,
             normal sperm morphology>4%;

         14. Patients with other systemic diseases who are being treated with other drugs that may
             affect semen quality.
Male
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 45 Years

Patient description (medical language): A 39-year-old man comes to the emergency department with an acute onset of severe left toe pain.  The toe is red and exhibits swelling. The patient is not febrile, and does not remember any recent trauma. Medical history is not significant except for the similar attacks and the diagnosis of gouty arthritis. His medication history includes Allopurinol to prevent gouty attacks. His father has the same medical condition. However, his older brother who is 41 years old is healthy with no history of gouty arthritis. Physical examination shows a swollen, tender first metatarsophalangeal joint.  Aspiration of the joint showed high leukocyte count, negative Gram stain, and numerous needle-shaped crystals, which is compatible with gouty arthritis.

Patient description (patient's own words): I'm a 39-year-old man and got admitted to the ER after an unbearable pain in my left toe. My toe was red and terribly swollen. I was still standing on my feet, not febrile and I don't remember hitting my head or anything. I don't have any special medical history, but I had been diagnosed with gout before. I take Lopurin to prevent my gouty attacks. My dad had the same problem, but my 41-year-old brother is healthy and does not have gouty attacks. The doctor did a physical exam and found that the joints between my toes and the rest of my foot were swollen and tender. The doctor renewed his diagnosis of gouty arthritis.

Does the patient match the trial criteria? Contradiction