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

NCT ID: NCT03953781

Last Updated: 2019-05-17

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 50 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-06-01
• Study Completion Date: 2017-06-30

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.

Conditions

Epilepsy

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

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

Effect of valporate on Reproductive Functions in Newly Diagnosed Epileptic Males

Intervention Type: 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.

Effect of levetiracetam on epileptic males reproductive function

Intervention Type: DRUG

Interventions

Effect of valporate on Reproductive Functions in Newly Diagnosed Epileptic Males

Intervention Type: DRUG

Effect of levetiracetam on epileptic males reproductive function

Intervention Type: DRUG

Other Intervention Names

Effect of depakin monotherapy on epileptic males reproductive function; Effect of levepex on epileptic males reproductive function

Eligibility Criteria

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 .

• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Zagazig University

OTHER_GOV

Sponsor Role: lead

Responsible Party

rania sanad

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

ZU-IRB#4731\ 24-1-2018

Identifier Type: -

Identifier Source: org_study_id