Back to resultsAssessment of Seminal Levels of Cystatin C and Endoglin in Infertile Men With Varicocele
Primary Purpose
Varicocele, Infertility, Male
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Varicocelectomy
Sponsored by
About this trial
This is an interventional basic science trial for Varicocele focused on measuring Male infertility, Varicocele, Cystatin C, Endoglin
Eligibility Criteria
Inclusion Criteria:
- Infertile men
- Varicocele
- Poor sperm parameters
Exclusion Criteria:
- Men with systemic diseases
- Infertile men due to other causes than varicocele
Sites / Locations
- Benha Faculty of Medecine
- Benha Faculty of Medicine
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Varicocelectomy
Arm Description
Subinguinal varicocelectomy under general anesthesia and complete aseptic condition
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04856579
Brief Title
Assessment of Seminal Levels of Cystatin C and Endoglin in Infertile Men With Varicocele
Official Title
Assessment of Seminal Levels of Cystatin C and Endoglin in Infertile Men With Varicocele
Study Type
Interventional
2. Study Status
Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
January 1, 2019 (Actual)
Primary Completion Date
December 31, 2020 (Actual)
Study Completion Date
December 31, 2020 (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
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
Detailed Description
Subinguinal varicocelectomy under general anesthesia and complete aseptic condition was done to infertile men with varicocele
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Varicocele, Infertility, Male
Keywords
Male infertility, Varicocele, Cystatin C, Endoglin
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Varicocelectomy
Arm Type
Other
Arm Description
Subinguinal varicocelectomy under general anesthesia and complete aseptic condition
Intervention Type
Procedure
Intervention Name(s)
Varicocelectomy
Intervention Description
Subinguinal varicocelectomy under general anesthesia and complete aseptic condition
Primary Outcome Measure Information:
Title
The Quality of Semen
Description
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
10. Eligibility
Sex
Male
Gender Based
Yes
Gender Eligibility Description
Infertile men with varicocele
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
39 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Infertile men
Varicocele
Poor sperm parameters
Exclusion Criteria:
Men with systemic diseases
Infertile men due to other causes than varicocele
Facility Information:
Facility Name
Benha Faculty of Medecine
City
Banhā
Country
Egypt
Facility Name
Benha Faculty of Medicine
City
Banhā
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Assessment of Seminal Levels of Cystatin C and Endoglin in Infertile Men With Varicocele
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