ClinicalTrials.gg
CompletedNCT04856579Updated Apr 23, 2021

Assessment of Seminal Levels of Cystatin C and Endoglin in Infertile Men With Varicocele

An interventional study of Varicocelectomy in Varicocele and Infertility, Male, sponsored by Benha University. Completed at 2 sites in Egypt. Open to male participants aged 18 Years to 39 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-04-23.

Sponsored by Benha University · Not applicable, Interventional, and Basic science

From the registry’s dates

  • Registered 2 years 3 months after the study started (first participant enrolled Jan 2019, registered Apr 2021).
Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Not applicable
Ages
18 Years to 39 Years
Sex
Male
01

Study 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. 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

02

Conditions studied

  • Varicocele
  • Infertility, Male

Keywords

  • Male infertility
  • Varicocele
  • Cystatin C
  • Endoglin
03

In context

Varicocele

53 studies on the registry are indexed under Varicocele; 15 are open to participants now.

This study's enrollment of 30 is below the median of 72 across 36 interventional studies indexed under Varicocele.

Browse Varicocele studies →

Lead sponsor

Benha University is the lead sponsor of 362 studies on the registry; 66 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 39 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Infertile men
  • Varicocele
  • Poor sperm parameters

Exclusion criteria

Exclusion Criteria:

  • Men with systemic diseases
  • Infertile men due to other causes than varicocele
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
30 participants (actual)

Study arms

  • Other
    Varicocelectomy

    Subinguinal varicocelectomy under general anesthesia and complete aseptic condition

    Procedure: Varicocelectomy

Interventions

  • ProcedureVaricocelectomy

    Subinguinal varicocelectomy under general anesthesia and complete aseptic condition

06

What researchers measure

Primary outcomes

  1. 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).

    Time frame: 6 months

07

Study locations

2 sites
  • Benha Faculty of Medecine
    Banhā, Egypt
  • Benha Faculty of Medicine
    Banhā, Egypt
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Jan 2019 to primary completion in Dec 2020, 23 months.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 6, 2021
First posted
Apr 23, 2021
StartActual
Jan 1, 2019
Primary completionActual
Dec 31, 2020
CompletionActual
Dec 31, 2020
Last update
Apr 23, 2021
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 23, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04856579
Lead sponsor
Benha University
Responsible party
Essam Mohamed El-sayed Akl (Assistant Professor, Benha University) — Principal investigator
First posted
Apr 23, 2021
Start date
Jan 1, 2019
Primary completion
Dec 31, 2020
Completion
Dec 31, 2020
Last update
Apr 23, 2021

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2021. You cannot join it, but the record below documents what was studied.

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