Male InfertilityPhase 2/3NCT05616598
Effect of New Oral Treatment for Hepatitis C Virus on Seminal Parameters
A Phase 2/3 study testing Sofosbuvir +daclatasvir+ simeprevir+Ribavirin in people with Male Infertility and HCV, run by Benha University at 2 sites in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Male Infertility, HCV
- What is being tested?
- Sofosbuvir +daclatasvir+ simeprevir+Ribavirin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 2 sitesEgypt
- Study dates
- 1 Mar 2022to 31 Dec 2022
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Men patients with HCV
Who cannot join
- Patients with other hepatic disease, endocrinal disorder, malignancy, or urinary tract infection.
Trial locations and contacts
2 sites in 1 country.
Egypt2 sites
Faculty of Medicine, Benha University
Al Qalyūbīyah, Benha
Benha Faculty of Medecine
Banhā
About this study
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.
Read the 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.
- Conditions
- Male Infertility, HCV
- Being tested
- Sofosbuvir +daclatasvir+ simeprevir+Ribavirin
- Keywords
- Semen, DAA, Male infertility
- Medical subject headings
- Infertility, Male
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sofosbuvir +daclatasvir+ simeprevir+RibavirinDrug
Oral daily dose of Sofosbuvir +daclatasvir + simeprevir+ Ribavirin for 3 months
| Study group | Role | What they receive |
|---|---|---|
| Pateint group | Active comparator | Men with HCV Receives: Drug: Sofosbuvir +daclatasvir+ simeprevir+Ribavirin |
| Control group | No intervention | Men without HCV |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment of HCV
HCV titer by PCR is below detection level
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2022
- Study start1 Mar 2022
- Primary completion25 Nov 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Male InfertilityStudies of the same condition, open and under way.
- More trials run by Benha UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- DAA oral therapy for HCV.
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Benha University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Essam Mohamed El-sayed Akl, Benha University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05616598
- Sponsor's protocol ID
- RC 39-10-2022
- Status last verified
- Feb 2023
- First submitted
- 1 Nov 2022
- Last updated
- 8 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of New Oral Treatment for Hepatitis C Virus on Seminal Parameters
- ClinicalTrials.gov ID
- NCT05616598
- Acronym / sponsor ID
- RC 39-10-2022
- Conditions
- Male Infertility, HCV
- Keywords
- Semen, DAA, Male infertility
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Benha UniversityUniversity, hospital or other
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 25 Nov 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 15 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- DAA oral therapy for HCV.
| Arm | Type | Receives |
|---|---|---|
| Pateint group | Active comparator | Drug: Sofosbuvir +daclatasvir+ simeprevir+RibavirinMen with HCV |
| Control group | No intervention | –Men without HCV |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Men patients with HCV
Key exclusion criteria (1 listed)
- Patients with other hepatic disease, endocrinal disorder, malignancy, or urinary tract infection.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sofosbuvir +daclatasvir+ simeprevir+RibavirinOral daily dose of Sofosbuvir +daclatasvir + simeprevir+ Ribavirin for 3 months | Drug | Pateint group |
Primary outcome
Treatment of HCV
Time frame: 3 months
HCV titer by PCR is below detection level
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Sofosbuvir +daclatasvir+ simeprevir+Ribavirin in people with Male Infertility and HCV, run by Benha University at 2 sites in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment of HCV (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2023.