Infertility, Male Clinical Trial
Official title:
The Effect of Preliminary Varicocele Repair on IVF Outcomes in Male Factor Infertility
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.
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.
;
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 |