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

NCT03953781 | Completed DMC FDA Drug

• 1 other identifier: ZU-IRB#4731\ 24-1-2018
• Study Type: observational
• Target: 50
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Epilepsy

Keywords

Epilepsy; antiepileptic drugs; males; reproduction

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• 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

Study Arms (2)

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

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

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.

Drug: Effect of levetiracetam on epileptic males reproductive function

Interventions

Effect of valporate on Reproductive Functions in Newly Diagnosed Epileptic Males DRUG

Also known as: Effect of depakin monotherapy on epileptic males reproductive function

group 1

Effect of levetiracetam on epileptic males reproductive function DRUG

Also known as: Effect of levepex on epileptic males reproductive function

group 2

Eligibility Criteria

• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The study included 50 newly diagnosed epileptic males (clinically and electro physiologically ((EEG)) according to the International League against Epilepsy ((ILAE)) classification 2010)

You may qualify if:

• 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.

You may not qualify if:

• 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 .

Sponsors & Collaborators

• Zagazig University: lead

MeSH Terms

Conditions

Epilepsy

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 17, 2019
• First Posted: May 17, 2019
• Study Start: June 1, 2016
• Primary Completion: March 31, 2017
• Study Completion: June 30, 2017
• Last Updated: May 17, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: after publishing the manuscript in the Egyptian journal of neurology, psychiatry and neurosurgery
• Access Criteria: after publishing the manuscript in the Egyptian journal of neurology, psychiatry and neurosurgery