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Assessment 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
Benha University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Varicocele focused on measuring Male infertility, Varicocele, Cystatin C, Endoglin

Eligibility Criteria

18 Years - 39 Years (Adult)MaleAccepts Healthy Volunteers

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

First Posted
April 6, 2021
Last Updated
April 20, 2021
Sponsor
Benha University
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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

Learn more about this trial

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

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