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

NCT ID: NCT03344588

Last Updated: 2017-11-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 330 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-01-01
• Study Completion Date: 2017-10-31

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.

Conditions

Infertility, Male; Oligozoospermia; Varicocelectomy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

artery preserving varicocelectomy

In all patients, sub-inguinal varicocelectomy will be carried out under spinal anesthesia, by a single surgeon (KS), using surgical microscope. A 2-3 cm pre-pubic incision will be performed. The cord will be grasped with a Babcock clamp and isolated over a vessel tape. Any external cremastric veins will be identified and ligated using vicryl 3/0. After opening the spermatic fascia, the vassal compartment including the vasal, cremasteric arteries and lymphatics will be separated from the pampiniform plexus compartment and preserved. In group A (APV), testicular arteries will be spared with aid of by intraoperative Doppler US (VTI intraoperative Doppler system 20 MHz). The arteries will be carefully dissected by a micro-dissector, separated over a vessel loupe, and then the remaining veins will be ligated using vicryl 3/0.

Group Type: ACTIVE_COMPARATOR

artery preserving varicocelectomy

Intervention Type: PROCEDURE

During sub-inguinal varicocelectomy, testicular arteries will be spared with aid of by intraoperative Doppler US (VTI intraoperative Doppler system 20 MHz). The arteries will be carefully dissected by a micro-dissector, separated over a vessel loupe, and then the remaining veins will be ligated using vicryl 3/0.

artery ligation varicocelectomy

In all patients, sub-inguinal varicocelectomy will be carried out under spinal anesthesia, by a single surgeon (KS), using surgical microscope. A 2-3 cm pre-pubic incision will be performed. The cord will be grasped with a Babcock clamp and isolated over a vessel tape. Any external cremastric veins will be identified and ligated using vicryl 3/0. After opening the spermatic fascia, the vassal compartment including the vasal, cremasteric arteries and lymphatics will be separated from the pampiniform plexus compartment and preserved. In group B (ALV), all vascular channels will be ligated without identifying or sparing the internal spermatic arteries

Group Type: ACTIVE_COMPARATOR

artery ligation varicocelectomy

Intervention Type: PROCEDURE

During sub-inguinal varicocelectomy, all vascular channels will be ligated without identifying or sparing the internal spermatic arteries.

Interventions

artery preserving varicocelectomy

During sub-inguinal varicocelectomy, testicular arteries will be spared with aid of by intraoperative Doppler US (VTI intraoperative Doppler system 20 MHz). The arteries will be carefully dissected by a micro-dissector, separated over a vessel loupe, and then the remaining veins will be ligated using vicryl 3/0.

Intervention Type: PROCEDURE

artery ligation varicocelectomy

During sub-inguinal varicocelectomy, all vascular channels will be ligated without identifying or sparing the internal spermatic arteries.

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Mansoura University

OTHER

Sponsor Role: lead

Responsible Party

Mohamed Hassan Zahran

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Urology and Nephrology Center

Al Mansurah, Dakahlia Governorate, Egypt

Countries

Egypt

Other Identifiers

varicocelectomy

Identifier Type: -

Identifier Source: org_study_id