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

Completed

• Conditions: Epilepsy
• Interventions: Drug: Effect of valporate on Reproductive Functions in Newly Diagnosed Epileptic Males; Drug: Effect of levetiracetam on epileptic males reproductive function

• Registration Number: NCT03953781
• Lead Sponsor: Zagazig University

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2016-06-01
• Primary Completion: 2017-03-31
• Study Completion: 2017-06-30
• Study First Submitted: 2019-04-17
• Status Verified: 2019-05
• Study First Submitted QC: 2019-05-14
• Last Update Submitted: 2019-05-14
• Study First Posted: 2019-05-17
• Last Update Posted: 2019-05-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 50

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 .

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
group 1	Effect of valporate on Reproductive Functions in Newly Diagnosed Epileptic Males	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 2	Effect of levetiracetam on epileptic males reproductive function	25 participants were treated by levetiracetam (LEV) with the same regimens of valproate as a monotherapy, with ages ranged from 20-45 years.

Primary Outcome Measures

Name	Time	Method
the effect of levetiracetam on males' sex hormones in newly diagnosed epileptic males.	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.	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.	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.	8-weeks	percent of valproate treated patients with change in luteinizing hormone and follicle stimulating hormones and prolactin serum level.