Back to resultsEffect of New Oral Treatment for Hepatitis C Virus on Seminal Parameters
Primary Purpose
Male Infertility, HCV
Status
Completed
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
Sofosbuvir +daclatasvir+ simeprevir+Ribavirin
Sponsored by
About this trial
This is an interventional basic science trial for Male Infertility focused on measuring Semen, DAA, Male infertility
Eligibility Criteria
Inclusion Criteria: Men patients with HCV Exclusion Criteria: Patients with other hepatic disease, endocrinal disorder, malignancy, or urinary tract infection.
Sites / Locations
- Faculty of Medicine, Benha University
- Benha Faculty of Medecine
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
Pateint group
Control group
Arm Description
Men with HCV
Men without HCV
Outcomes
Primary Outcome Measures
Treatment of HCV
HCV titer by PCR is below detection level
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05616598
Brief Title
Effect of New Oral Treatment for Hepatitis C Virus on Seminal Parameters
Official Title
Effect of New Oral Treatment for Hepatitis C Virus on Seminal Parameters
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
March 1, 2022 (Actual)
Primary Completion Date
November 25, 2022 (Actual)
Study Completion Date
December 31, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Benha University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Male Infertility, HCV
Keywords
Semen, DAA, Male infertility
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 2, Phase 3
Interventional Study Model
Single Group Assignment
Model Description
DAA oral therapy for HCV.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
200 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Pateint group
Arm Type
Active Comparator
Arm Description
Men with HCV
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Men without HCV
Intervention Type
Drug
Intervention Name(s)
Sofosbuvir +daclatasvir+ simeprevir+Ribavirin
Intervention Description
Oral daily dose of Sofosbuvir +daclatasvir + simeprevir+ Ribavirin for 3 months
Primary Outcome Measure Information:
Title
Treatment of HCV
Description
HCV titer by PCR is below detection level
Time Frame
3 months
10. Eligibility
Sex
Male
Gender Based
Yes
Gender Eligibility Description
Men patients with HCV
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Men patients with HCV
Exclusion Criteria:
Patients with other hepatic disease, endocrinal disorder, malignancy, or urinary tract infection.
Facility Information:
Facility Name
Faculty of Medicine, Benha University
City
Al Qalyūbīyah
State/Province
Benha
Country
Egypt
Facility Name
Benha Faculty of Medecine
City
Banhā
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effect of New Oral Treatment for Hepatitis C Virus on Seminal Parameters
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