NCT06257459

Brief Summary

In the current study, the adult infertile patients with clinical varicoceles will be included. the patients will undergo subinguinal varicocelectomy. The patients with spermatic cord lipoma detected at the time of surgery will be enrolled and divided into 2 groups( excision group, group A and preservation group (B). semen parameters will be compared in both group at 3 and 6 months after surgery

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2023

Typical duration for not_applicable

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2023

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

January 30, 2024

Completed
15 days until next milestone

First Posted

Study publicly available on registry

February 14, 2024

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2024

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

February 14, 2024

Status Verified

February 1, 2024

Enrollment Period

1.4 years

First QC Date

January 30, 2024

Last Update Submit

February 12, 2024

Conditions

Male Infertility

Outcome Measures

Primary Outcomes (2)

  • semen parameters improvement

    semen analysis

    3 and 6 months after surgery

  • symptoms improvement (pain and swelling)

    improvement of preoperative scrotal pain and swelling was assessed

    3 and 6 months after surgery

Secondary Outcomes (1)

  • postoperative complications

    early after surgery and late

Study Arms (2)

Lipoma Excision (group A)

ACTIVE COMPARATOR

excison of spermatic cord lipoma detected during subinguinal varicocelectomy in infertile males

Procedure: subinguinal varicocelectomy

Lipoma Preservation (group B)

ACTIVE COMPARATOR

preservation of spermatic cord lipoma detected during subinguinal varicocelectomy in infertile males

Procedure: subinguinal varicocelectomy

Interventions

subinguinal varicocelectomyPROCEDURE

exision or preservation of spermatic cord lipoma during subinguinal varicocelectomy

Lipoma Excision (group A)Lipoma Preservation (group B)

Eligibility Criteria

Age18 Years - 50 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Adult infertile males
  • Clinical varicocele
  • Semen analysis show oligo-athenospermia

You may not qualify if:

  • Adolescent varicocele
  • Recurrent varicocele
  • Presence of inguinal hernia
  • Azospermic patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ahmed Zoeir

Tanta, Gharbia Governorate, 11511, Egypt

RECRUITING

MeSH Terms

Conditions

Infertility, Male

Condition Hierarchy (Ancestors)

Genital Diseases, MaleGenital DiseasesUrogenital DiseasesInfertilityMale Urogenital Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
faculty of medicine, Tanta, ElGeish street, Egypt

Study Record Dates

First Submitted

January 30, 2024

First Posted

February 14, 2024

Study Start

January 1, 2023

Primary Completion

June 1, 2024

Study Completion

December 1, 2024

Last Updated

February 14, 2024

Record last verified: 2024-02

Locations

EG(1)