Condition category
Nervous System Diseases
Date applied
12/04/2020
Date assigned
26/04/2020
Last edited
24/04/2020
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting
Publication status
Results overdue

Plain English Summary

Background and study aims
Epilepsy is a common condition that affects the brain and causes frequent seizures. Seizures are bursts of electrical activity in the brain that temporarily affect how it works.
Epilepsy is a common chronic neurological disorder with a worldwide prevalence of approximately 1%. Globally, there were 45.9 million patients with active epilepsy (both idiopathic and secondary epilepsy) in 2016. The first-line therapy for epilepsy is antiepileptic drugs (AEDs) treatment, and approximately 70% of people with epilepsy can achieve seizure control with a single antiepileptic medication. The National Institute for Health and Care Excellence guidelines recommend carbamazepine (CBZ) or lamotrigine (LTG) as first-line treatment options for patients with newly diagnosed partial seizures and then recommend levetiracetam (LEV), OXC, or VPA if CBZ and LTG are unsuitable or not tolerated. High-quality evidence also indicates that CBZ and LTG are suitable first-line treatments for patients with partial-onset seizures and demonstrates that LEV may be a suitable alternative. However, because CBZ and LTG have higher rash rates than the other three drugs, LEV is more expensive than OXC or VPA. Therefore, VPA and OXC continue to be commonly used AEDs for partial seizures. Clinical studies on the side effects of VPA and OXC have mostly focused on liver and gastrointestinal dysfunction, abnormal blood parameters, rashes and similar effects. It has been reported that VPA and OXC may be associated with decreased sexual function and increased frequency of morphologically abnormal sperm. There is evidence that VPA can lead to a significant reduction in the levels of FSH and testosterone (T) in male patients with epilepsy compared with healthy controls.
However, there remains controversy regarding the effects of VPA and OXC on the sexual function of male patients with epilepsy. Moreover, there have been few studies regarding the effects of OXC on semen quality and sex hormone levels. At the same time, due to the demand for reproductive health in reproductive-aged men, the current study aimed to evaluate the effects of VPA and OXC on sexual function, semen, and sex hormones in newly diagnosed young male epilepsy patients and provide a reference for AED selection in these patients.

Who can participate?
Adult male patients with simple partial seizures, complex partial seizures or secondarily generalized seizures. Healthy young male volunteers form the control group.

What does the study involve?
Participants will have semen quality, sex hormone levels, and sexual function assessments at baseline and six months. Epilepsy patients will be randomly allocated to receive one of two different epilepsy drugs for the six month study period.

What are the possible benefits and risks of participating?
None.

Where is the study run from?
Epilepsy Center of People's Hospital of Sichuan Province (China)

When is the study starting and how long is it expected to run for?
September 2014 to December 2016

Who is funding the study?
Sichuan Provincial People’s Hospital for Doctors or Youths (China)

Who is the main contact?
Qiong’ Zhu, zhuqiong427@126.com

Trial website

Contact information

Type

Scientific

Primary contact

Mr Qiong' Zhu

ORCID ID

http://orcid.org/0000-0001-7747-8975

Contact details

Sichuan Provincial People’s Hospital
32# W. Sec 2
1st Ring Rd.
Chengdu
610000
China
+86 17708130527
zhuqiong427@126.com

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

Nil known

Study information

Scientific title

The effects of sodium valproate and oxcarbazepine on semen, sex hormones and sexual function in young male patients with epilepsy

Acronym

Study hypothesis

This study aims to evaluate the effect of VPA and OXC on semen quality, sex hormones and sexual function in young male patients with partial epilepsy.

Ethics approval

Approved 13/03/2013, Ethics committee of Sichuan Academy of Medical Sciences and Sichuan Provincial People’s Hospital (32# W. Sec 2, 1st Ring Rd. Chengdu, China; +86-028-87393265; no email provided), ref: none provided

Study design

Observational case-control

Primary study design

Observational

Secondary study design

Case-control study

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Epilepsy

Intervention

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 survey will be conducted using the International Index of Erectile Function 5 (IIEF-5) regarding participants’ sexual life. Semen quality, sexual function questionnaire scores and sex hormone results will be compared between the two groups.

The epileptic patients are treated with VPA (trade name: Depakote; 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/kg. The dosage of OXC is initially 300 mg twice daily, then gradually increased to an effective dose, and the maximum daily dose will not exceed 2400 mg/d. All patients will be followed up once a month by a doctor. After 6 months of treatment, the semen quality and sex hormones of the patients will be tested again, and the IIEF-5 questionnaire used to evaluate the patients’ sexual life. Semen quality, sexual function questionnaire scores, and sex hormone levels will be compared between the VPA group and the OXC group before and after treatment.

Intervention type

Drug

Phase

Phase IV

Drug names

Sodium valproate, oxcarbazepine

Primary outcome measure

Quality of semen measured using lab test of semen sample at baseline and six months

Secondary outcome measures

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

Overall trial start date

13/01/2013

Overall trial end date

15/12/2016

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Patients with simple partial seizures, complex partial seizures or secondarily generalized seizures
2. Healthy young male volunteers (control group)

Participant type

Patient

Age group

Adult

Gender

Male

Target number of participants

77

Participant 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

Recruitment start date

30/09/2014

Recruitment end date

01/12/2016

Locations

Countries of recruitment

China

Trial participating centre

Epilepsy Center of People's Hospital of Sichuan Province
32# W. Sec 2, 1st Ring Rd.
Chengdu
610000
China

Sponsor information

Organisation

Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital

Sponsor details

32# W. Sec 2
1st Ring Rd.
Chengdu
610000
China
+86-028-87393265
zhuqiong427@126.com

Sponsor type

University/education

Website

https://www.samsph.com/

Funders

Funder type

Hospital/treatment centre

Funder name

Sichuan Provincial People’s Hospital for Doctors or Youths

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer-reviewed journal.

IPD sharing statement:
All data generated or analysed during this study will be included in the subsequent results publication.

Intention to publish date

30/12/2025

Participant level data

Other

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

21/04/2020: Trial’s existence confirmed by ethics committee of Sichuan Academy of Medical Sciences and Sichuan Provincial People’s Hospital.