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临床试验/NCT03953781
NCT03953781已完成不适用

Effect of Valproate Versus Levetiracetam Monotherapy on Reproductive Functions in Newly Diagnosed Epileptic Males

Zagazig University0 个研究点目标入组 50 人开始时间: 2016年6月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
50
主要终点
the effect of levetiracetam on males' sex hormones in newly diagnosed epileptic males.

研究概览

简要总结

Background: Different antiepileptic drugs are responsible for reproductive dysfunction in male epileptic patients. The aim of this study is to evaluate the effect of valproate versus levetiracetam as a monotherapy on males' sex hormones and sperm parameters in newly diagnosed epilepsy. Methods: This comparative study included 50 newly diagnosed epileptic male participants from outpatient clinic of Neurology department of Zagazig University Hospitals. All participants were subjected to complete general and neurological examination, Doppler ultrasonography of the testis, pre and post treatment serum sex hormone assay and semen analysis. Post- treatment re- evaluation check point was determined if eight weeks have passed after the last seizures. This study included two groups, group I: 25 participants, were treated by valproate (VPA) as a monotherapy till became seizure free at the last 8-weeks before post treatment check-point, with ages ranged from 18-43 years. Group II: 25 participants were treated by levetiracetam (LEV) with the same regimens of valproate as a monotherapy, with ages ranged from 20-45 years.

详细描述

Background: Epilepsy is a chronic neurological disorder characterized by recurrent epileptic attacks and researches have reported that the relation between epilepsy and the reproductive dysfunction is not yet completely understood. Seizures are linked with sexual dysfunction as part of the disease pathophysiology in these patients. Through epileptic discharge, hypothalamus receives signals from hippocampus, amygdala and cerebral cortex. Hypothalamic-pituitary axis signaling changes is leading to sex hormones release including follicle stimulating hormones and luteinizing hormone changes.

However, the available antiepileptic drugs (AED) have not yet been proven to have negative impacts on sexual function. Evaluation of AED induced sexual dysfunction is complicated, less than clear, and is hard to find. Sex hormone levels can be changed due to AEDs which are the cause of sexual dysfunction and reproductive disorders Different antiepileptic drugs are responsible for reproductive dysfunction in male epileptic patients. The aim of this study is to evaluate the effect of valproate versus levetiracetam as a monotherapy on males' sex hormones and sperm parameters in newly diagnosed epilepsy. Methods: This comparative study included 50 newly diagnosed epileptic male participants from outpatient clinic of Neurology department of Zagazig University Hospitals. All participants were subjected to complete general and neurological examination, Doppler ultrasonography of the testis, pre and post treatment serum sex hormone assay and semen analysis. Post- treatment re- evaluation check point was determined if eight weeks have passed after the last seizures. This study included two groups, group I: 25 participants, were treated by valproate (VPA) as a monotherapy till became seizure free at the last 8-weeks before post treatment check-point, with ages ranged from 18-43 years. Group II: 25 participants were treated by levetiracetam (LEV) with the same regimens of valproate as a monotherapy, with ages ranged from 20-45 years.

研究设计

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

入排标准

性别
Male
接受健康志愿者

入选标准

  • Ages between 18-45 years.
  • All participants had normal brain imaging (Brain CT or MRI).
  • All participants had normal thyroid functions and normal sex hormones assay.

排除标准

  • participants are currently receiving hormonal replacement therapy, or any drugs that may affect reproductive functions were excluded.
  • participants with significant or progressive medical illness.
  • participants with testicular atrophy, varicocele or infectious diseases .

研究组 & 干预措施

group 1

25 participants, were treated by valproate (VPA) as a monotherapy till became seizure free at the last 8-weeks before post treatment check-point, with ages ranged from 18-43 years

干预措施: Effect of valporate on Reproductive Functions in Newly Diagnosed Epileptic Males (Drug)

group 2

25 participants were treated by levetiracetam (LEV) with the same regimens of valproate as a monotherapy, with ages ranged from 20-45 years.

干预措施: Effect of levetiracetam on epileptic males reproductive function (Drug)

结局指标

主要结局

the effect of levetiracetam on males' sex hormones in newly diagnosed epileptic males.

时间窗: 8-weeks

percent of levetiracetam treated patients with change in luteinizing hormone and follicle stimulating hormones and prolactin serum level.

the effect of valproate on sperm parameters in newly diagnosed epileptic males.

时间窗: 8-weeks

percent of valproate treated patients with change in semen analysis parameters.

the effect of levetiracetam on sperm parameters in newly diagnosed epileptic males.

时间窗: 8-weeks

percent of levetiracetam treated patients with change in semen analysis parameters.

the effect of valproate on males' sex hormones in newly diagnosed epileptic males.

时间窗: 8-weeks

percent of valproate treated patients with change in luteinizing hormone and follicle stimulating hormones and prolactin serum level.

次要结局

未报告次要终点

研究者

申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

rania sanad

Principal Investigator

Zagazig University

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