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

• Sponsor: Benha University (Other)
• Overall Status: Completed
• CT.gov ID: NCT04856579
• Collaborator: (none)
• Enrollment: 30
• Locations: 2
• Arm: 1
• Actual Duration (Months): 24
• Patients Per Site: 15
• Patients Per Site Per Month: 0.6

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Varicocele; Infertility, Male	Procedure: Varicocelectomy	N/A

Detailed Description

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

Study Design

• Study Type: Interventional
• Actual Enrollment: 30 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Basic Science
• Official Title: Assessment of Seminal Levels of Cystatin C and Endoglin in Infertile Men With Varicocele
• Actual Study Start Date: Jan 1, 2019
• Actual Primary Completion Date: Dec 31, 2020
• Actual Study Completion Date: Dec 31, 2020

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. The Quality of Semen [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).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 39 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Infertile men

• Varicocele

• Poor sperm parameters

Exclusion Criteria:

• Men with systemic diseases

• Infertile men due to other causes than varicocele

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Benha Faculty of Medecine	Banhā		Egypt
2	Benha Faculty of Medicine	Banhā		Egypt

Sponsors and Collaborators

• Benha University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Essam Mohamed El-sayed Akl, Assistant Professor, Benha University
• ClinicalTrials.gov Identifier: NCT04856579
• Other Study ID Numbers: RC-5-4-2021
• First Posted: Apr 23, 2021
• Last Update Posted: Apr 23, 2021
• Last Verified: Apr 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Essam Mohamed El-sayed Akl, Assistant Professor, Benha University: Male infertility; Varicocele; Cystatin C; Endoglin
• Additional relevant MeSH terms: Infertility; Varicocele; Infertility, Male

Study Results

No Results Posted as of Apr 23, 2021