NCT07008495

Brief Summary

A varicocele is an abnormal dilatation and tortuosity of the veins of the spermatic cord. Although varicoceles are common in the general population and are frequently found on routine physical examinations, they represent the most common correctable cause of male factor infertility. Male factor infertility affects up to half of all couples struggling to conceive, and 10-20% of men evaluated for infertility are found to be azoospermic.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2024

Geographic Reach
1 country

1 active site

Status
recruiting

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

September 1, 2024

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

May 28, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 6, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 20, 2025

Completed
11 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2025

Completed
Last Updated

June 13, 2025

Status Verified

September 1, 2024

Enrollment Period

12 months

First QC Date

May 28, 2025

Last Update Submit

June 10, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Sperm retrieval rate

    Evaluation of Sperm retrieval rate after varicocelectomy in men with non obstructive azoospermia

    Two Weeks

Secondary Outcomes (1)

  • fertility rate

    3 months from the operation

Study Arms (2)

Group of varicocele ligation

ACTIVE COMPARATOR

About 25 male patients will undergo varicocele ligation then microTESE.

Procedure: varicocelectomy

Group of TESE

ACTIVE COMPARATOR

About 25 male patients will undergo microTESE without varicocele ligation.

Procedure: varicocelectomy

Interventions

to detect testicular sperm retrieval rate after varicocelectomy in men with non obstructive azoospermia.

Also known as: TESE
Group of TESEGroup of varicocele ligation

Eligibility Criteria

Age20 Years - 60 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Men with non obstructive azoospermia.
  • Clinically palpable varicocele ( unilateral or bilateral ).

You may not qualify if:

  • Known cases of obstructive azoospermia.
  • Non palpable varicocele.
  • Uncorrectable female causes of infertility.
  • genetic abnormalities like klinefelter syndrome.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

South Valley University Hospital

Qina, South Valley, Egypt

RECRUITING

Study Officials

  • Gamal A. Alsagheer, Professor

    Urology Department, Faculty of Medicine, South Valley University, Qena, Egypt

    STUDY CHAIR

Central Study Contacts

Yacoub Nagah Abdelwahab, Resident

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident at Urology Department, Faculty of Medicine

Study Record Dates

First Submitted

May 28, 2025

First Posted

June 6, 2025

Study Start

September 1, 2024

Primary Completion

August 20, 2025

Study Completion

August 31, 2025

Last Updated

June 13, 2025

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL

Locations