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

Phase 2

Completed

• Conditions: HCV; Male Infertility
• Interventions: Drug: Sofosbuvir +daclatasvir+ simeprevir+Ribavirin

• Registration Number: NCT05616598
• Lead Sponsor: Benha University

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2022-03-01
• Study First Submitted: 2022-11-01
• Study First Submitted QC: 2022-11-07
• Study First Posted: 2022-11-15
• Primary Completion: 2022-11-25
• Study Completion: 2022-12-31
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-06
• Last Update Posted: 2023-02-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 200

Inclusion Criteria

Men patients with HCV

Exclusion Criteria

Patients with other hepatic disease, endocrinal disorder, malignancy, or urinary tract infection.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Pateint group	Sofosbuvir +daclatasvir+ simeprevir+Ribavirin	Men with HCV

Primary Outcome Measures

Name	Time	Method
Treatment of HCV	3 months	HCV titer by PCR is below detection level

Trial Locations

Locations (2)

Faculty of Medicine, Benha University; 🇪🇬 Al Qalyūbīyah, Benha, Egypt

Benha Faculty of Medecine; 🇪🇬 Banhā, Egypt