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

NCT03344588 | Completed

• 1 other identifier: varicocelectomy
• Study Type: interventional
• Target: 330
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• semen parameters changes, sperm density

  number/ml according to WHO criteria)

  at 6 months

• sperm motility

  percentage ( according to WHO criteria)

  at 6 months

Secondary Outcomes (1)

• clinical pregnancy rate

  1 year

Study Arms (2)

artery preserving varicocelectomy

ACTIVE COMPARATOR

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.

Procedure: artery preserving varicocelectomy

artery ligation varicocelectomy

ACTIVE COMPARATOR

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

Procedure: artery ligation varicocelectomy

Interventions

artery preserving varicocelectomy 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 preserving varicocelectomy

artery ligation varicocelectomy PROCEDURE

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

artery ligation varicocelectomy

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: the study included males with primary infertility
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Urology and Nephrology Center

Al Mansurah, Dakahlia Governorate, 35516, Egypt

Location

MeSH Terms

Conditions

Infertility, Male; Oligospermia

Condition Hierarchy (Ancestors)

Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Infertility; Male Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Patients accept to participate have to sign a written informed consent and will be unaware of randomization.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: November 12, 2017
• First Posted: November 17, 2017
• Study Start: January 1, 2013
• Primary Completion: September 30, 2017
• Study Completion: October 31, 2017
• Last Updated: November 21, 2017

Record last verified: 2017-11

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)