Objective: To determine whether high ligation is an effective treatmen
t for infertile men with clinical varicocele. Design: A randomized, co
ntrolled trial of high spermatic vein ligation was carried out. The pa
tients were treated and observed for 3 years. Setting: Infertility tre
atment clinic and andrology laboratory in a hospital. Patients: Infert
ile men with abnormal semen analysis because of varicocele only. Inter
vention: High ligation I year postrecruitment (group A) and at the beg
inning of the study (group B). Results: Among the 20 couples in group
A, 2 pregnancies (10%) were achieved within the Ist year of observatio
n period. During the year after high ligation, there were 8 pregnancie
s (44.4%), and during the 2nd year after high ligation, there were 4 m
ore pregnancies (22.2%). In group B, 15 pregnancies (60%) occurred wit
hin the Ist year after operation. Three pregnancies (12%) and 1 pregna
ncy (4%) occurred during the 2nd and 3rd year, respectively. After ope
ration in all patients of both groups, there was significant improveme
nt in semen parameters, regardless of pregnancy occurrence. The differ
ence in pregnancy rate (PR) between the operated group B and nonoperat
ed group A during the Ist year of study was found to be highly signifi
cant. Conclusions: It is concluded that in a population of infertile m
en presenting varicocele as the only demonstrable factor of infertilit
y, the varicocele is clearly associated with infertility and reduced t
esticular function, and its correction by ligation improves sperm para
meters and fertility rate. Furthermore, the highest PR in both groups
occurred during the Ist year postoperation.