NCT03344588

The Role of Artery-Preserving Varicocelectomy in Subfertile Men With Severe Oligozoospermia.

Completed NA Last updated 21 November 2017

What this trial tests

NA trial testing artery preserving varicocelectomy in Infertility, Male in 330 participants. Completed in 31 October 2017.

Timeline

1 January 2013

Primary endpoint
30 September 2017

31 October 2017

Quick facts

Lead sponsor	Mansoura University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	330
Start date	1 January 2013
Primary completion	30 September 2017
Estimated completion	31 October 2017
Sites	1 location across Egypt

Drugs / interventions tested

• artery preserving varicocelectomy
• artery ligation varicocelectomy

Conditions studied

• Infertility, Male — all drugs for Infertility, Male →
• Oligozoospermia — all drugs for Oligozoospermia →
• Varicocelectomy — all drugs for Varicocelectomy →

Sponsor

Mansoura University

Who can join

18 and older, male only, with Infertility, Male or Oligozoospermia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.