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

Epilepsy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03953781
• Other study ID #: ZU-IRB#4731\ 24-1-2018
• Status: Completed
• Start date: June 1, 2016
• Est. completion date: June 30, 2017

Study information

• Verified date: May 2019
• Source: Zagazig University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: June 30, 2017
• Est. primary completion date: March 31, 2017
• Gender: Male
• Age group: N/A and older

Eligibility

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 .

Related Conditions & MeSH terms

• Epilepsy

Intervention

Drug:
• Effect of valporate on Reproductive Functions in Newly Diagnosed Epileptic Males

• Effect of levetiracetam on epileptic males reproductive function

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Zagazig University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the effect of valproate on males' sex hormones in newly diagnosed epileptic males.	percent of valproate treated patients with change in luteinizing hormone and follicle stimulating hormones and prolactin serum level.	8-weeks
Primary	the effect of valproate on sperm parameters in newly diagnosed epileptic males.	percent of valproate treated patients with change in semen analysis parameters.	8-weeks
Primary	the effect of levetiracetam on males' sex hormones in newly diagnosed epileptic males.	percent of levetiracetam treated patients with change in luteinizing hormone and follicle stimulating hormones and prolactin serum level.	8-weeks
Primary	the effect of levetiracetam on sperm parameters in newly diagnosed epileptic males.	percent of levetiracetam treated patients with change in semen analysis parameters.	8-weeks