NCT04856579

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2019

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2019

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 6, 2021

Completed
17 days until next milestone

First Posted

Study publicly available on registry

April 23, 2021

Completed
Last Updated

April 23, 2021

Status Verified

April 1, 2021

Enrollment Period

2 years

First QC Date

April 6, 2021

Last Update Submit

April 20, 2021

Conditions

VaricoceleInfertility, Male

Keywords

Male infertilityVaricoceleCystatin CEndoglin

Outcome Measures

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).

    6 months

Study Arms (1)

Varicocelectomy

OTHER

Subinguinal varicocelectomy under general anesthesia and complete aseptic condition

Procedure: Varicocelectomy

Interventions

VaricocelectomyPROCEDURE

Subinguinal varicocelectomy under general anesthesia and complete aseptic condition

Varicocelectomy

Eligibility Criteria

Age18 Years - 39 Years
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsInfertile men with varicocele
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Infertile men
  • Varicocele
  • Poor sperm parameters

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Benha Faculty of Medecine

Banhā, Egypt

Location

Benha Faculty of Medicine

Banhā, Egypt

Location

MeSH Terms

Conditions

VaricoceleInfertility, Male

Condition Hierarchy (Ancestors)

Genital Diseases, MaleGenital DiseasesUrogenital DiseasesMale Urogenital DiseasesVascular DiseasesCardiovascular DiseasesInfertility

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

April 6, 2021

First Posted

April 23, 2021

Study Start

January 1, 2019

Primary Completion

December 31, 2020

Study Completion

December 31, 2020

Last Updated

April 23, 2021

Record last verified: 2021-04

Locations

EG(2)