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

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

Study Description

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.

Study Design

• 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

Groups and Cohorts

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

Outcome Measures

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.

Eligibility Criteria

• 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 .

Contacts and Locations

No Contacts or Locations Provided

More Information

• Responsible Party: rania sanad, Principal Investigator, Zagazig University
• ClinicalTrials.gov Identifier: NCT03953781
• Other Study ID Numbers: ZU-IRB#4731\ 24-1-2018
• First Posted: May 17, 2019
• 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

• 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:

Epilepsy; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Levetiracetam; Anticonvulsants; Nootropic Agents