Overview

This trial is active, not recruiting.

Condition varicocele; male infertile;varicocelectomy
Treatments open operation, microsurgery
Sponsor First Affiliated Hospital, Sun Yat-Sen University
Start date December 2012
End date November 2014
Trial size 1000 participants
Trial identifier NCT01757548, S2011010005282

Summary

The purpose of this study is to determine whether high ligation of spermatic vein by open operation and microsurgery for patients with are effective in the treatment of varicocele and to determine which surgical option is better.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
high ligation of spermatic vein by open operation
open operation
high ligation of spermatic vein by open operation
(Experimental)
high ligation of spermatic vein by microsurgery
microsurgery
high ligation of spermatic vein by microsurgery

Primary Outcomes

Measure
the quality of semen and the level of sexual hormone
time frame: before and three and six months after surgery
complications
time frame: one, three and six months postoperation

Secondary Outcomes

Measure
If there was pain, visual analogue scale,Numerical rating scale and verbal rating scale would be used to evaluate pain intensity. pain intensity
time frame: before and one,three and six months after surgery

Eligibility Criteria

Male participants from 10 years up to 50 years old.

Inclusion Criteria: - 1.infertile patient suffering from varicocele 2.severe varicocele patient with obvious symptoms 3.adolescents suffering from severe varicocele with or without orchiatrophy Exclusion Criteria: - 1.varicocele patient with abdominal infection 2.varicocele patient who has massive adhesion of pelvic tissue due to pelvic surgery history 3.mild varicocele 4.varicocele patient has no obvious symptoms if has have born children, suffer from idiopathic azoospermia,or their partner can't bear children

Additional Information

Official title The Effect and Prognosis of Different Operations on Varicocele - a Single-center Clinical Study
Trial information was received from ClinicalTrials.gov and was last updated in December 2012.
Information provided to ClinicalTrials.gov by First Affiliated Hospital, Sun Yat-Sen University.