An interventional study of artery preserving varicocelectomy and artery ligation varicocelectomy in Infertility, Male, Oligozoospermia and Varicocelectomy, sponsored by Mansoura University. Completed at 1 site in Egypt. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-11-21.
Sponsored by Mansoura University · Not applicable, Interventional, and Treatment
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.
64 studies on the registry are indexed under Oligospermia; 17 are open to participants now.
This study's enrollment of 330 is above the median of 65 across 46 interventional studies indexed under Oligospermia.
Browse Oligospermia studies →Mansoura University is the lead sponsor of 1,119 studies on the registry; 183 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Compared within Oligospermia, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Infertility, Male. The counts are of registry records indexed under each term, refreshed daily. How we classify →
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Exclusion Criteria:
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
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
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.
During sub-inguinal varicocelectomy, all vascular channels will be ligated without identifying or sparing the internal spermatic arteries.
semen parameters changes, sperm density
number/ml according to WHO criteria)
Time frame: at 6 months
sperm motility
percentage ( according to WHO criteria)
Time frame: at 6 months
clinical pregnancy rate
number of pregnancy in each group
Time frame: 1 year
Plan to share: No
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