VaricoceleNCT04856579
Assessment of Seminal Levels of Cystatin C and Endoglin in Infertile Men With Varicocele
A study testing Varicocelectomy in people with Varicocele and Infertility, Male, run by Benha University at 2 sites in Egypt.
Trial summary
Varicocele is a major contributor in male infertility. The improvement of sperm parameters after varicocelectomy supports this contribution. The pathophysiological mechanisms of varicocele-induced male infertility are still under investigation. Read more about this study
- Who is it for?
- Ages 18 to 39 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Varicocele, Infertility, Male
- What is being tested?
- Varicocelectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesEgypt
- Study dates
- 1 Jan 2019to 31 Dec 2020
- Phase
- Interventional
- 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 39 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Infertile men
- Varicocele
- Poor sperm parameters
Who cannot join
- Men with systemic diseases
- Infertile men due to other causes than varicocele
Trial locations and contacts
2 sites in 1 country.
About this study
Varicocele is a major contributor in male infertility. The improvement of sperm parameters after varicocelectomy supports this contribution. The pathophysiological mechanisms of varicocele-induced male infertility are still under investigation. Cystatin C (Cys C) and endoglin are secreted glycoproteins that recently linked to several cellular changes common in varicocele like apoptosis and autophagy.
Read the detailed description
Subinguinal varicocelectomy under general anesthesia and complete aseptic condition was done to infertile men with varicocele
- Conditions
- Varicocele, Infertility, Male
- Being tested
- Varicocelectomy
- Keywords
- Male infertility, Varicocele, Cystatin C, Endoglin
- Medical subject headings
- Varicocele, Infertility, Male
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VaricocelectomyProcedure or surgery
Subinguinal varicocelectomy under general anesthesia and complete aseptic condition
| Study group | Role | What they receive |
|---|---|---|
| Varicocelectomy | Other | Subinguinal varicocelectomy under general anesthesia and complete aseptic condition Receives: Procedure: Varicocelectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Quality of Semen
According to WHO 2010 guidelines regarding semen analysis
- Sperm concentration (to be more than 15 million sperm per milliliter).
- Sperm motility (not less than 60% progressive motility).
- Sperm morphology (not less than 6% normal morphology).
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2021
- Study start1 Jan 2019
- Primary completion31 Dec 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for VaricoceleStudies 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 N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 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
- NCT04856579
- Sponsor's protocol ID
- RC-5-4-2021
- Status last verified
- Apr 2021
- First submitted
- 6 Apr 2021
- Last updated
- 23 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Seminal Levels of Cystatin C and Endoglin in Infertile Men With Varicocele
- ClinicalTrials.gov ID
- NCT04856579
- Acronym / sponsor ID
- RC-5-4-2021
- Conditions
- Varicocele, Infertility, Male
- Keywords
- Male infertility, Varicocele, Cystatin C, Endoglin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Benha UniversityUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 23 Apr 2021 (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.
Varicocele is a major contributor in male infertility. The improvement of sperm parameters after varicocelectomy supports this contribution. The pathophysiological mechanisms of varicocele-induced male infertility are still under investigation. Cystatin C (Cys C) and endoglin are secreted glycoproteins that recently linked to several cellular changes common in varicocele like apoptosis and autophagy.
Detailed description
Subinguinal varicocelectomy under general anesthesia and complete aseptic condition was done to infertile men with varicocele
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Varicocelectomy | Other | Procedure: VaricocelectomySubinguinal varicocelectomy under general anesthesia and complete aseptic condition |
Who may qualify
- Ages
- 18 to 39 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Infertile men
- Varicocele
- Poor sperm parameters
Key exclusion criteria (2 listed)
- Men with systemic diseases
- Infertile men due to other causes than varicocele
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 |
|---|---|---|
| VaricocelectomySubinguinal varicocelectomy under general anesthesia and complete aseptic condition | Procedure or surgery | Varicocelectomy |
Primary outcome
The Quality of Semen
Time frame: 6 months
According to WHO 2010 guidelines regarding semen analysis * Sperm concentration (to be more than 15 million sperm per milliliter). * Sperm motility (not less than 60% progressive motility). * Sperm morphology (not less than 6% normal morphology).
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 23 Apr 2021.
- Individual participant dataSharing planned: Undecided
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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 study testing Varicocelectomy in people with Varicocele and Infertility, Male, 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 3 inclusion and 2 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 23 Apr 2021. 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.
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?
The Quality of Semen (time frame: 6 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 23 Apr 2021.