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NCT05616598 Clinical Trial

Effect of New Oral Treatment for Hepatitis C Virus on Seminal Parameters

Male Infertility Clinical Trial

Official title:
Effect of New Oral Treatment for Hepatitis C Virus on Seminal Parameters

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05616598
Other study ID # RC 39-10-2022
Secondary ID
Status Completed
Phase Phase 2/Phase 3
First received
Last updated
Start date March 1, 2022
Est. completion date December 31, 2022

Study information
Verified date February 2023
Source Benha University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Hepatitis C virus is commona viral infection. Direct-acting antiviral (DAA) oral drugs has been used in treatment of HCVs. the effect of these drugs on male infertility is still under investigation.

Description:

Semen analysis will be done to male patients with HCV before and after treatment with DAA. The included men will take therapy for 3 months and HCV RNA titter will be evaluated. changes of seminal parameters will be recorded and analyzed.

Recruitment information / eligibility
Status Completed
Enrollment 200
Est. completion date December 31, 2022
Est. primary completion date November 25, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years to 55 Years
Eligibility Inclusion Criteria: Men patients with HCV Exclusion Criteria: Patients with other hepatic disease, endocrinal disorder, malignancy, or urinary tract infection.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Sofosbuvir +daclatasvir+ simeprevir+Ribavirin
Oral daily dose of Sofosbuvir +daclatasvir + simeprevir+ Ribavirin for 3 months

Locations
Country Name City State
Egypt Faculty of Medicine, Benha University Al Qalyubiyah Benha
Egypt Benha Faculty of Medecine Banha

Sponsors (1)
Lead Sponsor Collaborator
Benha University

Country where clinical trial is conducted

Egypt, 

Outcome
Type Measure Description Time frame Safety issue
Primary Treatment of HCV HCV titer by PCR is below detection level 3 months
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