Clinical Trials Logo

Clinical Trial Summary

Infertility has been estimated to affect from 6-18% of couples trying to conceive. In 20-30% of cases, the problem is with the male. Varicocele is a common cause of male factor infertility (MFI) being responsible for 30-35 % of primary and 69-81 % of secondary MFI. Varicocele repair has been shown to improve sperm parameters and increase natural pregnancy rates and the results of assisted reproductive techniques (ART).

There are two possible treatment pathways for varicocele associated male factor infertility. 1) standard IVF/ICSI 2) varicocele repair followed by IVF/ICSI if there is no spontaneous pregnancy. There is however no consensus as to which pathway is preferable and no randomized comparative studies have been carried out.

IVF/ICSI is a standard treatment for infertility but frequently requires repeated treatments to achieve a live birth. The purpose of this study is to determine if the improved sperm parameters caused by prior treatment of the varicocele will result in improvements both in overall pregnancy/birth rates and in IVF/ICSI results.


Clinical Trial Description

A varicocele is an abnormal dilation of the pampiniform plexus caused by incompetence of the valves in the internal spermatic vein. Varicocele has a prevalence of 10-15 % in the general population and is a common cause of male infertility, being present in 30-35% of men with primary, and 69-81% of men with secondary infertility. There is more than one approach to the treatment of varicocele associated MFI One common approach is to treat by assisted reproductive techniques (ART). Patients with a total motile sperm count of <10 million sperm are usually treated by IVF with or without ICSI. Fertilization of oocytes may be accomplished by isolating even a single adequate spermatozoa in the laboratory bypassing the majority of semen quality inadequacies in male factor infertility. The results of this treatment using fresh embryos with a maternal age of<35 are 46% pregnancies and 40% live births per cycle.

Alternatively, varicocele associated MFI can be treated by repairing the varicocele to improve sperm quality. Occlusion of the spermatic veins by surgical and radiological methods is commonly performed in these circumstances to improve fertility. A large body of literature exists demonstrating post-treatment improvements in semen parameters and sperm DNA quality as well as improved spontaneous pregnancy rates compared to no treatment. There are also studies demonstrating improved results of ART after varicocele repair.

Both approaches have their advocates. ART often provide a relatively quick result and have a known excellent track record for both pregnancy and live birth rates. Unfortunately, these techniques are not without risks such as ovarian hyperstimulation syndrome and procedural complications. Multiple pregnancies are common with increased risk of premature labour and low birth weight. In addition the treatments are expensive and multiple treatments increase the financial burden on the health care system.

Varicocele occlusion is a minor procedure. If performed radiologically, there is often immediate return to normal activity. The complication rate is very low, mostly due to radiological contrast medium allergy. Modern equipment and careful technique enable the procedure to be completed with very low radiation doses that are well below the level proven to have any adverse biological effect.

If varicocele repair can be demonstrated to improve pregnancy outcomes in varicocele related MFI by spontaneous pregnancies or by improving pregnancy and live birth rates per ART implantation, then there are compelling health care and economic reasons for incorporating it as an initial treatment.

At present there have been no well constructed randomized trials to compare the outcomes of these two approaches. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03090438
Study type Interventional
Source Shaare Zedek Medical Center
Contact Anthony G Verstandig, MD
Phone 972 508685879
Email anthonyv@szmc.org.il
Status Not yet recruiting
Phase N/A
Start date May 2017
Completion date May 2021

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
Recruiting NCT03968367 - To Study the Effect of Magnetic Activated Sperm Sorting on the Outcome of in Vitro Fertilization-embryo Transplantation N/A