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

Primary Purpose

Infertility, Male, Oligozoospermia, Varicocelectomy

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
artery preserving varicocelectomy
artery ligation varicocelectomy
Sponsored by
Mansoura University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Infertility, Male

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Urology and Nephrology Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

artery preserving varicocelectomy

artery ligation varicocelectomy

Arm Description

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.

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

Outcomes

Primary Outcome Measures

semen parameters changes, sperm density
number/ml according to WHO criteria)
sperm motility
percentage ( according to WHO criteria)

Secondary Outcome Measures

clinical pregnancy rate
number of pregnancy in each group

Full Information

First Posted
November 12, 2017
Last Updated
November 18, 2017
Sponsor
Mansoura University
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1. Study Identification

Unique Protocol Identification Number
NCT03344588
Brief Title
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

2. Study Status

Record Verification Date
November 2017
Overall Recruitment Status
Completed
Study Start Date
January 1, 2013 (Actual)
Primary Completion Date
September 30, 2017 (Actual)
Study Completion Date
October 31, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mansoura University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility, Male, Oligozoospermia, Varicocelectomy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Masking Description
Patients accept to participate have to sign a written informed consent and will be unaware of randomization.
Allocation
Randomized
Enrollment
330 (Actual)

8. Arms, Groups, and Interventions

Arm Title
artery preserving varicocelectomy
Arm Type
Active Comparator
Arm Description
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.
Arm Title
artery ligation varicocelectomy
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Procedure
Intervention Name(s)
artery preserving varicocelectomy
Intervention Description
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
Intervention Name(s)
artery ligation varicocelectomy
Intervention Description
During sub-inguinal varicocelectomy, all vascular channels will be ligated without identifying or sparing the internal spermatic arteries.
Primary Outcome Measure Information:
Title
semen parameters changes, sperm density
Description
number/ml according to WHO criteria)
Time Frame
at 6 months
Title
sperm motility
Description
percentage ( according to WHO criteria)
Time Frame
at 6 months
Secondary Outcome Measure Information:
Title
clinical pregnancy rate
Description
number of pregnancy in each group
Time Frame
1 year

10. Eligibility

Sex
Male
Gender Based
Yes
Gender Eligibility Description
the study included males with primary infertility
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Urology and Nephrology Center
City
Mansoura
State/Province
El Dakahlia
ZIP/Postal Code
35516
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No

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

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