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临床试验/NCT00385762
NCT00385762已完成不适用

Effect of Selective Serotonin Reuptake Inhibitor Antidepressants on Semen Parameters

Weill Medical College of Cornell University1 个研究点 分布在 1 个国家目标入组 35 人开始时间: 2007年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
35
试验地点
1
主要终点
Sperm Motility

研究概览

简要总结

According to the National Institute of Mental Health, depressive disorders afflict over six million U.S. men annually. Most cases of moderate or severe depression are treated with antidepressants, including monoamine oxidase inhibitors, tricyclic antidepressants, and, more recently, selective serotonin reuptake inhibitors (SSRIs) and antidepressants with modest serotonin and norepinephrine reuptake inhibition but unknown mechanism-of-action. Over the past two years, prescribing data show a steady increase in antidepressant dispensing rates (especially including serotonin reuptake inhibitors) for adults. SSRIs are known to have an effect on ejaculatory function and are therapeutically used for treatment of premature (rapid) ejaculation. However, few studies have evaluated the potential impact of antidepressant medications on male fertility, and no studies have been published with respect to the impact of newer antidepressants, such as SSRIs, on male fertility. In the high-volume male infertility practice at New York Hospital-Cornell Medical Center, several patients have presented who have had a clear temporal association between SSRI use and impairment in sperm motility and/or sperm transport (emission). These men have shown improvement in sperm counts and motility after discontinuation of antidepressant medications.

详细描述

We propose a crossover pilot study of normal healthy males to ascertain possible effects of SSRIs on semen parameters. After initial screening semen analyses, subjects will take the SSRI paroxetine for five weeks. Serial semen analyses will be obtained while on medication and one month after discontinuation of medication. Comparisons between semen parameters on and off medication will be used to evaluate the frequency and significance of semen analysis changes during SSRI treatment.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • Normal, healthy male volunteers, ages 18-65
  • Must be able to swallow pills

排除标准

  • Known sexual dysfunction
  • Tobacco use
  • Prescription medications
  • History of psychiatric disorders
  • Previous chemotherapy or radiation treatment
  • History of seizure disorder
  • Alcohol use greater than 2 ounces daily
  • Illicit drug use
  • Azoospermia on screening semen analysis
  • Varicocele
  • Currently attempting to achieve pregnancy

结局指标

主要结局

Sperm Motility

时间窗: 2 months post initial visit

percent of sperm with movement

Semen Volume

时间窗: 2 months post initial visit

measured in mL

Sperm Concentration

时间窗: 2 months post initial visit

number of sperm per cubic centimeter of semen

Sperm Morphology

时间窗: 2 months post initial visit

percent of sperm with normal shape

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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