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Clinical Trials/NCT03344588
NCT03344588
Completed
Not Applicable

The Role of Artery-Preserving Varicocelectomy in Subfertile Men With Severe Oligozoospermia; A Randomized Controlled Study

Mansoura University1 site in 1 country330 target enrollmentJanuary 1, 2013

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Infertility, Male
Sponsor
Mansoura University
Enrollment
330
Locations
1
Primary Endpoint
semen parameters changes, sperm density
Status
Completed
Last Updated
8 years ago

Overview

Brief Summary

A male factor is responsible for almost half the cases of subfertility. Varicocele is a major cause of impaired spermatogenesis and potentially a correctable cause. It affects up to 40% of men with primary subfertility and 80% of men with secondary subfertility. Varicocelectomy is now accepted as a cost effective treatment in subfertile men with clinically palpable varicocele and impaired semen parameters. Recently, Varicocelectomy is reported to improve fertility potential in patients with severe oligozoospermia. In one such study, Varicocelectomy was associated with a statistically significant increase in sperm density and motility. Spontaneous pregnancy was achieved in16.7% of cases. In a recent meta-analysis, Varicocelectomy in men with severe oligozoospermia showed a strong trend toward improvement in pregnancy rate (PR) [OR= 1.69, 95% CI (0.951, 3.020), p= 0.073] and statistically significant increase in live birth rate (LBR)[OR=1.699, 95%CI (1.020, 2.831), p= 0.04].

The impact of ligation of internal spermatic artery (ISA) during Varicocelectomy is a matter of debate. Conventional view is arterial ligation can negatively affect testicular function and decrease the likelihood of post-operative paternity. Other investigators reported that ligation of ISA was not associated with significant changes in postoperative semen parameters, testicular size or PR in comparison to artery preservation. Moreover, laparoscopic artery-ligating Varicocelectomy was proved to be superior in the form of shorter operative time and lower recurrence rates with no difference in semen parameters or PR in comparison to laparoscopic artery-preservation varicocelectomy.

Also, isolation of ISA is not an easy task during subinguinal Varicocelectomy due to compression by external oblique aponeurosis and its inherent anatomical variation. In 29 % and 57% of the cases, the ISA is surrounded by the varicose vessels and adherent to the veins respectively. Thus, the ISA is liable to a substantial risk of accidental ligation during subinguinal Varicocelectomy.

Whether or not ligation of the ISA has a deleterious effect on the fertility outcomes in patients with severe oligozoospermia; this is not clear in the literature. This prospective randomized study was conducted to assess the impact of ISA ligation during subinguinal Varicocelectomy on fertility outcome in patients with severe oligozoospermia.

Registry
clinicaltrials.gov
Start Date
January 1, 2013
End Date
October 31, 2017
Last Updated
8 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Male

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Mohamed Hassan Zahran

MD

Mansoura University

Eligibility Criteria

Inclusion Criteria

  • adult sub-fertile male
  • with clinical varicocele (grade 2,3) severe oligozoospermia (\<5 million/ml)

Exclusion Criteria

  • patients' age \< 18 years, recurrent varicocele, sperm concentration \>5 million/ml, history of previous inguinal surgery, concomitant female factor subfertility and refusal to participate in the study.

Outcomes

Primary Outcomes

semen parameters changes, sperm density

Time Frame: at 6 months

number/ml according to WHO criteria)

sperm motility

Time Frame: at 6 months

percentage ( according to WHO criteria)

Secondary Outcomes

  • clinical pregnancy rate(1 year)

Study Sites (1)

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