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

NCT04213534 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 60

Last updated 2023-04-10

No results posted yet for this study

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

Sponsors & Collaborators

  • Peking University Third Hospital

    lead OTHER

Principal Investigators

  • Jinxia Zhao, doctorate · Peking University Third Hospital

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-10-10
Primary Completion
2023-06-30
Completion
2023-12-31

Countries

  • China

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04213534 on ClinicalTrials.gov