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

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ClinicalTrials.gov Identifier: NCT03953781
Recruitment Status : Completed
First Posted : May 17, 2019
Last Update Posted : May 17, 2019
Sponsor:
Information provided by (Responsible Party):
rania sanad, 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.

Condition or disease Intervention/treatment
Epilepsy Drug: Effect of valporate on Reproductive Functions in Newly Diagnosed Epileptic Males Drug: Effect of levetiracetam on epileptic males reproductive function

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.


Layout table for study information
Study Type : Observational
Actual Enrollment : 50 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Effect of Valproate Versus Levetiracetam Monotherapy on Reproductive Functions in Newly Diagnosed Epileptic Males
Actual Study Start Date : June 1, 2016
Actual Primary Completion Date : March 31, 2017
Actual Study Completion Date : June 30, 2017


Group/Cohort Intervention/treatment
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
Other Name: Effect of depakin monotherapy on epileptic males reproductive function

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
Other Name: Effect of levepex on epileptic males reproductive function




Primary Outcome Measures :
  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.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
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)
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 .

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Responsible Party: rania sanad, Principal Investigator, Zagazig University
ClinicalTrials.gov Identifier: NCT03953781     History of Changes
Other Study ID Numbers: ZU-IRB#4731\ 24-1-2018
First Posted: May 17, 2019    Key Record Dates
Last Update Posted: May 17, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: after publishing the manuscript in the Egyptian journal of neurology, psychiatry and neurosurgery
Supporting Materials: Study Protocol
Statistical Analysis Plan (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
URL: http://ejnpn.springeropen.com

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by rania sanad, Zagazig University:
Epilepsy
antiepileptic drugs
males
reproduction
Additional relevant MeSH terms:
Layout table for MeSH terms
Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Levetiracetam
Valproic Acid
Anticonvulsants
Nootropic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
GABA Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Antimanic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs