NCT03281915

Brief Summary

to evalute the effect inguinal and subinguinal approach of varicoceclectomy on semen parameter for patients complaining of varicocele with normal semen parameter (pain is the main complaint)

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
32

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2017

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

August 25, 2017

Completed
19 days until next milestone

First Posted

Study publicly available on registry

September 13, 2017

Completed
1 month until next milestone

Study Start

First participant enrolled

October 15, 2017

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 15, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 15, 2018

Completed
Last Updated

September 13, 2017

Status Verified

September 1, 2017

Enrollment Period

1 year

First QC Date

August 25, 2017

Last Update Submit

September 11, 2017

Conditions

Varicocele

Keywords

infertilitypainpregnancy

Outcome Measures

Primary Outcomes (1)

  • Semen analysis

    Motility morphology concentration

    3months

Study Arms (2)

high inguinal approch

Patients undergoing high inguinal varicocelectomy with normal pre operative semen parameters, post operative semen analysis parameters will be recorded

Procedure: High inguinal Varicocelectomy

subinguinal approch

Patients undergoing subinguinal varicocelectomy with normal pre operative semen parameters, post operative semen analysis parameters will be recorded

Procedure: Subinguinal varicocelectomy

Interventions

High inguinal VaricocelectomyPROCEDURE

Semen parameters after high inguinal varicocelectomy will be collected

high inguinal approch
Subinguinal varicocelectomyPROCEDURE

Semen parameters after subinguinal Varicocelectomy will be collected

subinguinal approch

Eligibility Criteria

Age19 Years - 45 Years
Sexmale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Male patients undergoing varicocelectomy while having normal semen parameters (doing surgery for other reasons eg. pain)

You may qualify if:

  • age more than 19 years old
  • primary varicocele

You may not qualify if:

  • secondary varicocele recurrent varicocele age less than 19 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assuit Medical School

Asyut, Assuit, 71621, Egypt

Location

Related Publications (5)

  • Leslie SW, Sajjad H, Siref LE. Varicocele. 2023 Nov 13. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2025 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK448113/

    PMID: 28846314BACKGROUND

  • Wu X, Liu Q, Zhang R, Wang W, Gao Y. Therapeutic efficacy and safety of laparoscopic surgery versus microsurgery for varicocele of adult males: A meta-analysis. Medicine (Baltimore). 2017 Aug;96(34):e7818. doi: 10.1097/MD.0000000000007818.

    PMID: 28834886BACKGROUND

  • Canning DA. Re: Sperm Concentration and Forward Motility are Not Correlated with Age in Adolescents with an Idiopathic Varicocele and Symmetrical Testicular Volumes. J Urol. 2017 Sep;198(3):472. doi: 10.1016/j.juro.2017.06.068. Epub 2017 Jun 20. No abstract available.

    PMID: 28817895BACKGROUND

  • Schmidt B. Membranes in artificial organs. Artif Organs. 1996 May;20(5):375-80. doi: 10.1111/j.1525-1594.1996.tb04519.x.

    PMID: 8725614BACKGROUND

  • Sedaghatpour D, Berookhim BM. The Role of Varicocele in Male Factor Subfertility. Curr Urol Rep. 2017 Sep;18(9):73. doi: 10.1007/s11934-017-0713-8.

    PMID: 28718159BACKGROUND

MeSH Terms

Conditions

VaricoceleInfertilityPain

Condition Hierarchy (Ancestors)

Genital Diseases, MaleGenital DiseasesUrogenital DiseasesMale Urogenital DiseasesVascular DiseasesCardiovascular DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Ehab O Ahmed

    unaffiliation

    STUDY DIRECTOR

  • Mohamed I Taha

    unaffiliation

    STUDY CHAIR

  • Ahmed k mohamed

    unaffiliation

    STUDY DIRECTOR

Central Study Contacts

Abdelrahman M Abdelkader

CONTACT

01068336396abdelrahmanmohamed.aa@gmail.com

Mohamed A Osman, professor

CONTACT

01062226639osman@aun.edu.eg

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident

Study Record Dates

First Submitted

August 25, 2017

First Posted

September 13, 2017

Study Start

October 15, 2017

Primary Completion

October 15, 2018

Study Completion

October 15, 2018

Last Updated

September 13, 2017

Record last verified: 2017-09

Locations

EG(1)