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Clinical Trials/NCT05616598
NCT05616598CompletedPhase 2

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

Benha University2 sites in 1 country200 target enrollmentStarted: March 1, 2022Last updated:
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Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 2
Status
Completed
Enrollment
200
Locations
2
Primary Endpoint
Treatment of HCV
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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 Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Single Group
Primary Purpose
Basic Science
Masking
None

Eligibility Criteria

Ages
18 Years to 55 Years (Adult)
Sex
Male
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • •Men patients with HCV

Exclusion Criteria

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

Arms & Interventions

Pateint group

Active Comparator

Men with HCV

Intervention: Sofosbuvir +daclatasvir+ simeprevir+Ribavirin (Drug)

Outcomes

Primary Outcomes

Treatment of HCV

Time Frame: 3 months

HCV titer by PCR is below detection level

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Essam Mohamed El-sayed Akl

Assistant Professor of Dermatology and Andrology

Benha University

Study Sites (2)

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