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

April 20, 2021 updated by: Essam Mohamed El-sayed Akl, Benha University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Subinguinal varicocelectomy under general anesthesia and complete aseptic condition was done to infertile men with varicocele

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Banhā, Egypt
        • Benha Faculty of Medecine
      • Banhā, Egypt
        • Benha Faculty of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 39 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Infertile men
  • Varicocele
  • Poor sperm parameters

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Varicocelectomy
Subinguinal varicocelectomy under general anesthesia and complete aseptic condition
Procedure: Varicocelectomy
Subinguinal varicocelectomy under general anesthesia and complete aseptic condition

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Benha University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2019

Primary Completion (Actual)

December 31, 2020

Study Completion (Actual)

December 31, 2020

Study Registration Dates

First Submitted

April 6, 2021

First Submitted That Met QC Criteria

April 20, 2021

First Posted (Actual)

April 23, 2021

Study Record Updates

Last Update Posted (Actual)

April 23, 2021

Last Update Submitted That Met QC Criteria

April 20, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RC-5-4-2021

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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