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

NCT ID: NCT05616598

Last Updated: 2023-02-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-01

Study Completion Date

2022-12-31

Brief Summary

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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

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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.

Conditions

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Male Infertility HCV

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

DAA oral therapy for HCV.
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Pateint group

Men with HCV

Group Type ACTIVE_COMPARATOR

Sofosbuvir +daclatasvir+ simeprevir+Ribavirin

Intervention Type DRUG

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

Control group

Men without HCV

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Sofosbuvir +daclatasvir+ simeprevir+Ribavirin

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

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

Men patients with HCV

Exclusion Criteria

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

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Benha University

OTHER

Sponsor Role lead

Responsible Party

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Essam Mohamed El-sayed Akl

Assistant Professor of Dermatology and Andrology

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Faculty of Medicine, Benha University

Al Qalyūbīyah, Benha, Egypt

Site Status

Benha Faculty of Medecine

Banhā, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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RC 39-10-2022

Identifier Type: -

Identifier Source: org_study_id

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