Clinical trial NCT03344588: The Role of Artery-Preserving Varicocelectomy in Subfertile Men With Severe Oligozoospermia.
Official title: The Role of Artery-Preserving Varicocelectomy in Subfertile Men With Severe Oligozoospermia; A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infertility, Male
Oligozoospermia
Varicocelectomy
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2017-11-17
Enrollment: 330
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: semen parameters changes, sperm density
timeFrame: at 6 months
measure: sperm motility
timeFrame: at 6 months
Secondary outcomes:
measure: clinical pregnancy rate
timeFrame: 1 year
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Urology and Nephrology Center
state: El Dakahlia
Study officials:
References: