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

Benha University

Status and phase: Completed; Phase 3; Phase 2

Conditions: Male Infertility; HCV

Treatments: Drug: Sofosbuvir +daclatasvir+ simeprevir+Ribavirin

Study type: Interventional

Funder types: Other

Identifiers

NCT05616598

RC 39-10-2022

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 patients

Sex: Male

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

Men patients with HCV

Exclusion criteria

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

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

Pateint group

Active Comparator group

Description:

Men with HCV

Treatment:

Drug: Sofosbuvir +daclatasvir+ simeprevir+Ribavirin

Control group

No Intervention group

Description:

Men without HCV