Epilepsy Nervous System Diseases
Conditions
Interventions
Semen quality and sex hormone levels are assessed in newly diagnosed young male epileptic patients and healthy volunteers who meet the inclusion criteria. Additionally, a sexual function questionnaire
packing specification: 500 mg × 30 pieces
Manufacturing: Sailof (Hangzhou) Pharmaceutical Co., Ltd.
batch number: H2O010595) or OXC (trade name: Trileptal
packing specification: 0.3 g × 50 pieces
Manufacturing: Novartis Farma S.P.A. (Italy)
batch number: H2O130016) randomly.
The dosage of VPA is initially 250 mg twice daily, then gradually increased to an effective dose, and the maximum daily dose will not exceed 30 mg/k
Sponsors
Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Patients with simple partial seizures, complex partial seizures or secondarily generalized seizures 2. Healthy young male volunteers (control group)
Exclusion criteria
Exclusion criteria: 1. Use of hormones, antidepressants, or drugs to improve sexual function 2. Liver and kidney dysfunction, thyroid disease, diabetes, infectious diseases, varicocele, cryptorchidism, history of testicular surgery, Klinefelter syndrome, or urinary system diseases 3. Long-term alcoholism, smoking, or exposure to toxic substances 4. Mental illness, intracranial occupying lesions, brain injury, or progressive degeneration of the nervous system 5. Inability to cooperate or refusal to participate in the study Individual participation in the study was terminated if any of the following conditions were met: 1. Patients experienced adverse drug reactions after taking the medications and needed to discontinue the drug 2. Patients failed to achieve an ideal treatment effect (i.e., the reduction in the frequency of epileptic seizures is less than 75% after three months of treatment), and other AEDs needed to be substituted or added 3. Patients or volunteers took medications or suffered from diseases that might affect the results during the study 4. Participants withdrew from the study for personal reasons
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Quality of semen measured using lab test of semen sample at baseline and six months | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Sex hormones measured using lab test of blood sample at baseline and six months 2. Sexual function measured using International Index of Erectile Function 5 (IIEF-5) at baseline and six months | — |
Countries
China
Outcome results
None listed