The Influence of Urate-lowering Therapy on Sperm Quality of Male Gouty Patients：A Prospective Cohort Study

NCT04213534 | Unknown

• 1 other identifier: M2019259
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Gout is a kind of crystal-associated arthropathy caused by monosodium urate deposition, which is directly related to hyperuricemia caused by purine metabolic disorder and/or decreased uric acid excretion. It belongs to the category of metabolic rheumatism. Gout can be complicated with kidney disease. The severe cases can occur joint destruction, renal function damage, and often accompanied by hyperlipidemia, hypertension, diabetes, arteriosclerosis and coronary heart disease and so on. The prevalence of gout varies greatly from different countries. But on the whole, the prevalence of gout is increasing year by year, and the incidence of gout is getting younger. With the continuous improvement of living standards in today's society, middle-aged men have quietly become a high incidence group of gout. The pathophysiological basis of gout is hyperuricemia, so reducing uric acid is the core of gout treatment. The reducing uric acid in patients with gout is a long-term process, and the drug can not be stopped after the serum uric acid is reduced to normal. Once patients with gout stop taking uric acid-lowering drugs, serum uric acid quickly returns to the pre-treatment level, which can not only cause gout attack again, but also bring the risk of kidney and cardio-cerebrovascular involvement if serum uric acid does not reach the control standard for a long time. Therefore, uric acid-lowering therapy requires the use of a minimum dose of uric acid-lowering drugs to maintain long-term uric acid levels. In recent years, with the aggravation of environmental pollution and the postponement of childbearing age, the incidence of male infertility is increasing year by year. However, there are relatively few studies on the effect of gout caused by hyperuricemia on male sperm quality. With the rejuvenation of gout patients and the long-term nature of uric acid-lowering therapy, the safety of uric acid-lowering drugs in male gout patients of childbearing age during pregnancy is not sure. Coupled with the opening of China's comprehensive second-child policy, more and more male gout patients join this fertility group. Unfortunately, so far, no animal or human trial has observed the effect of uric acid-lowering drugs on sperm quality. For this reason, this study intends to carry out this observational clinical trial to evaluate the effect of long-term use of uric acid-lowering drugs on male sperm quality by collecting relevant data of patients with gout treated with uric acid-lowering drugs. Aim to provide a theoretical basis for the safety of uric acid-lowering drugs during pregnancy.

Conditions

Gout

Keywords

gout; management; semen quality; male fertility; allopurinol; febuxostat; benzbromarone

Outcome Measures

Primary Outcomes (1)

• The mean change from baseline to week 12 in semen quality.

  According to the current world health orgnization semen analysis guidelines, semen quality evaluation can not use a single index to evaluate semen quality grade. The change of semen quality needs to be evaluated comprehensively from two aspects, namely basic semen analysis and sperm DNA integrity analysis Therefore, all the measurements will be aggregated to arrive at the reported value as semen quality.

  At baseline, week 4 and week 12 visits

Secondary Outcomes (1)

• Comparison of the reproductive hormone levels, oxidative stress level,the rate of the target serum urate level of <6.0 mg/dl at week12 of treatment, et al among different groups.

  At baseline, week 4 and week 12 visits

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: The purpose of this study is to investigate the effect of uric acid-lowering drugs on sperm quality, so the inclusion of patients must be male.
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

The patients included in this study are male patients with gout. These patients were treated in the outpatient clinic of the Department of Rheumatology and Immunology, Peking University Third Hospital, China. And they were followed up regularly in the outpatient clinic. We will give individualized uric acid lowering treatment according to the specific conditions of the patients on the basis of clinical routine. Then the effect of uric acid-lowering drugs on semen quality parameters was observed.

You may qualify if:

• Male, aged 18 \~45 years old;
• In accordance with the gout classification criteria of the American Rheumatic Society in 1977 or ACR/EULAR (European Alliance against Rheumatism) in 2015 ;
• Willing to receive uric acid-lowering drugs regularly for at least 3 months;
• No drugs affecting sperm quality were taken within 3 months before screening.
• Sign the informed consent form.

You may not qualify if:

• Patients who have a pregnancy plan during the trial;
• Patients with severe heart, liver, kidney and other important organs, blood and endocrine system diseases, the evaluation criteria are as follows:
• Heart disease: patients with a history of heart disease such as decompensated cardiac insufficiency, refractory hypertension or coronary heart disease;
• Liver function: alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) ≥ 2 times the upper limit of normal reference value (ULN);
• 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;
• leukocyte (WBC) count \<3 × 109/L and/or hemoglobin (Hb) \<100g/L and/or platelet (PLT) count \<80 × 109/L;
• Other serious diseases, such as tumors, etc;
• Those who are unable to cooperate with the treatment of mental illness or other reasons;
• Allergic constitution or multi-drug allergy;
• Those who are known to be allergic or intolerant to uric acid-lowering drugs in the trial;
• Chromosome abnormality or deletion of AZF region of Y chromosome;
• Previous history of orchitis, epididymitis, mumps or varicocele affecting sperm quality;
• Positive semen bacterial culture, or Chlamydia trachomatis, Ureaplasma Urealyticum and Mycoplasma hominis;
• Those who have a history of exposure to high temperature, chemistry, physics or toxicants in the past year;
• Those who undergo X-ray or CT examination in the past 3 months and during the period of enrollment;

Sponsors & Collaborators

• Peking University Third Hospital: lead

Study Sites (1)

Peking University Third Hospital

Beijing, Beijing Municipality, 100191, China

RECRUITING

MeSH Terms

Conditions

Gout

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Crystal Arthropathies; Rheumatic Diseases; Purine-Pyrimidine Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Jinxia Zhao, doctorate

  Peking University Third Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jinxia Zhao, doctorate

CONTACT

+86-13810098187; zhao-jinxia@163.com

Changhong Li, doctorate

CONTACT

+86-18901291436; changhongli@bjmu.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy department director

Study Record Dates

• First Submitted: December 20, 2019
• First Posted: December 30, 2019
• Study Start: October 10, 2020
• Primary Completion: June 1, 2023
• Study Completion: December 1, 2023
• Last Updated: April 10, 2023

Record last verified: 2023-04

Locations

CN (1)