NCT05616598

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Mar 2022

Shorter than P25 for phase_2

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2022

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

November 1, 2022

Completed
14 days until next milestone

First Posted

Study publicly available on registry

November 15, 2022

Completed
10 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 25, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

February 8, 2023

Status Verified

February 1, 2023

Enrollment Period

9 months

First QC Date

November 1, 2022

Last Update Submit

February 6, 2023

Conditions

Male InfertilityHCV

Keywords

SemenDAAMale infertility

Outcome Measures

Primary Outcomes (1)

  • Treatment of HCV

    HCV titer by PCR is below detection level

    3 months

Study Arms (2)

Pateint group

ACTIVE COMPARATOR

Men with HCV

Drug: Sofosbuvir +daclatasvir+ simeprevir+Ribavirin

Control group

NO INTERVENTION

Men without HCV

Interventions

Sofosbuvir +daclatasvir+ simeprevir+RibavirinDRUG

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

Pateint group

Eligibility Criteria

Age18 Years - 55 Years
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsMen patients with HCV
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Men patients with HCV

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Faculty of Medicine, Benha University

Al Qalyūbīyah, Benha, Egypt

Location

Benha Faculty of Medecine

Banhā, Egypt

Location

MeSH Terms

Conditions

Infertility, Male

Condition Hierarchy (Ancestors)

Genital Diseases, MaleGenital DiseasesUrogenital DiseasesInfertilityMale Urogenital Diseases

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Model Details: DAA oral therapy for HCV.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Dermatology and Andrology

Study Record Dates

First Submitted

November 1, 2022

First Posted

November 15, 2022

Study Start

March 1, 2022

Primary Completion

November 25, 2022

Study Completion

December 31, 2022

Last Updated

February 8, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations

EG(2)