Condition or disease | Intervention/treatment |
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Epilepsy | Drug: Effect of valporate on Reproductive Functions in Newly Diagnosed Epileptic Males Drug: Effect of levetiracetam on epileptic males reproductive function |
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 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 |
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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
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Drug: Effect of valporate on Reproductive Functions in Newly Diagnosed Epileptic Males
Other Name: Effect of depakin monotherapy on epileptic males reproductive function
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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.
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Drug: Effect of levetiracetam on epileptic males reproductive function
Other Name: Effect of levepex on epileptic males reproductive function
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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 |
Inclusion Criteria:
Exclusion Criteria:
No Contacts or Locations Provided
Tracking Information | |||||||||||||||
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First Submitted Date | April 17, 2019 | ||||||||||||||
First Posted Date | May 17, 2019 | ||||||||||||||
Last Update Posted Date | May 17, 2019 | ||||||||||||||
Actual Study Start Date | June 1, 2016 | ||||||||||||||
Actual Primary Completion Date | March 31, 2017 (Final data collection date for primary outcome measure) | ||||||||||||||
Current Primary Outcome Measures |
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Original Primary Outcome Measures | Same as current | ||||||||||||||
Change History | No Changes Posted | ||||||||||||||
Current Secondary Outcome Measures | Not Provided | ||||||||||||||
Original Secondary Outcome Measures | Not Provided | ||||||||||||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||||||||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||||||||||
Descriptive Information | |||||||||||||||
Brief Title | Effect of Valproate Versus Levetiracetam Monotherapy on Reproductive Functions in Epileptic Males | ||||||||||||||
Official Title | Effect of Valproate Versus Levetiracetam Monotherapy on Reproductive Functions in Newly Diagnosed Epileptic Males | ||||||||||||||
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. |
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Study Type | Observational | ||||||||||||||
Study Design | Observational Model: Case-Only Time Perspective: Prospective |
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Target Follow-Up Duration | Not Provided | ||||||||||||||
Biospecimen | Not Provided | ||||||||||||||
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) | ||||||||||||||
Condition | Epilepsy | ||||||||||||||
Intervention |
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Study Groups/Cohorts |
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Publications * | Not Provided | ||||||||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||||||||
Recruitment Status | Completed | ||||||||||||||
Actual Enrollment |
50 | ||||||||||||||
Original Actual Enrollment | Same as current | ||||||||||||||
Actual Study Completion Date | June 30, 2017 | ||||||||||||||
Actual Primary Completion Date | March 31, 2017 (Final data collection date for primary outcome measure) | ||||||||||||||
Eligibility Criteria |
Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | Child, Adult, Older Adult | ||||||||||||||
Accepts Healthy Volunteers | Not Provided | ||||||||||||||
Contacts | Contact information is only displayed when the study is recruiting subjects | ||||||||||||||
Listed Location Countries | Not Provided | ||||||||||||||
Removed Location Countries | |||||||||||||||
Administrative Information | |||||||||||||||
NCT Number | NCT03953781 | ||||||||||||||
Other Study ID Numbers | ZU-IRB#4731\ 24-1-2018 | ||||||||||||||
Has Data Monitoring Committee | Yes | ||||||||||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement |
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Responsible Party | rania sanad, Zagazig University | ||||||||||||||
Study Sponsor | Zagazig University | ||||||||||||||
Collaborators | Not Provided | ||||||||||||||
Investigators | Not Provided | ||||||||||||||
PRS Account | Zagazig University | ||||||||||||||
Verification Date | May 2019 |