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Completed

NCT Number: NCT03953781

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

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.

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Key information

Sex eligibility

Male

Study type

Observational

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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 .

Treatment and study plan

Effect of valporate on Reproductive Functions in Newly Diagnosed Epileptic Males

Drug

Other names: Effect of depakin monotherapy on epileptic males reproductive function

Effect of levetiracetam on epileptic males reproductive function

Drug

Other names: Effect of levepex on epileptic males reproductive function

Primary outcomes

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

    Time frame: 8-weeks

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

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

    Time frame: 8-weeks

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

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

    Time frame: 8-weeks

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

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

    Time frame: 8-weeks

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

Sponsors and collaborators

Lead sponsor

Zagazig University

Other Gov

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
May 17, 2019
Registry last updated
May 17, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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