Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03344588
Other study ID # varicocelectomy
Secondary ID
Status Completed
Phase N/A
First received November 12, 2017
Last updated November 18, 2017
Start date January 1, 2013
Est. completion date October 31, 2017

Study information

Verified date November 2017
Source Mansoura University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 330
Est. completion date October 31, 2017
Est. primary completion date September 30, 2017
Accepts healthy volunteers No
Gender Male
Age group 18 Years and older
Eligibility 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.

Study Design


Intervention

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

Locations

Country Name City State
Egypt Urology and Nephrology Center Mansoura El Dakahlia

Sponsors (1)

Lead Sponsor Collaborator
Mansoura University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary semen parameters changes, sperm density number/ml according to WHO criteria) at 6 months
Primary sperm motility percentage ( according to WHO criteria) at 6 months
Secondary clinical pregnancy rate number of pregnancy in each group 1 year
See also
  Status Clinical Trial Phase
Active, not recruiting NCT04142112 - Randomized, Standard-Controlled, Study to Evaluate the Ohana IVF Sperm Preparation Kit, SPeRtility IVF Next Generation N/A
Recruiting NCT04955782 - Abstinence Period and Semen Quality
Recruiting NCT05506722 - Using of Testes Shocker in Improving the Spermatogenesis and Sperms Activity N/A
Not yet recruiting NCT03988361 - Selection of Non Apoptotic Human Sperm for in Vitro Fertilization by Using Magnetic Activated Cell Sorting (MACS)
Completed NCT03319654 - Impact of DNA Fragmentation in Sperm on Pregnancy Outcome After Intra-uterine Insemination in a Spontaneous Cycle N/A
Not yet recruiting NCT05597631 - G-IVF and Sperm Parameters N/A
Completed NCT05919186 - Effects of Antioxidant Supplementation of Culture Media on IVF Embryos N/A
Recruiting NCT03588949 - Role of Nutritional Support in Idiopathic Male Infertility N/A
Recruiting NCT03527043 - Impact of Escitalopram on Sperm DNA Fragmentation Phase 2
Completed NCT02932865 - Modern Analyses of the Semen in Evaluating Male Fertility and Treatment Options of Male Infertility
Completed NCT02310087 - Oral Astaxanthin and Semen Quality, Fertilization and Embryo Development in Assisted Reproduction Techniques Procedures N/A
Completed NCT00385346 - Expressive Writing in Male Infertility N/A
Completed NCT04509583 - The Role of Micro Nutrient Supplement in Improvement of the Sperm DNA Fragmentation N/A
Recruiting NCT04144244 - Comparison of the Effect of Microchip and Density Gradient Methods in Intrauterine Insemination Cycles N/A
Recruiting NCT04452305 - Spermatogonial Stem Cell (SSC) Transplant and Testicular Tissue Grafting N/A
Completed NCT05461079 - Sperm Phenotype and Differentially Methylated Regions
Recruiting NCT05205733 - Expanding Fertility Care to Poor and Low Resourced Settings Study N/A
Completed NCT03960229 - The Evaluation of the Effect of Microfluidic Sperm Sorting Chip 'Labs-on-a-chip' on IVF Success in Male Factor N/A
Not yet recruiting NCT06050031 - Level of DNA-fragmentation Before and After Antioxidant-based Therapies in Male Infertility
Not yet recruiting NCT03090438 - IVF Outcomes After Varicocele Repair N/A