IVF Outcomes After Varicocele Repair
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|ClinicalTrials.gov Identifier: NCT03090438|
Recruitment Status : Not yet recruiting
First Posted : March 24, 2017
Last Update Posted : March 24, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Infertility, Male Varicocele In Vitro Fertilization||Procedure: Varicocele embolization||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||250 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||The Effect of Preliminary Varicocele Repair on IVF Outcomes in Male Factor Infertility|
|Estimated Study Start Date :||May 2017|
|Estimated Primary Completion Date :||May 2020|
|Estimated Study Completion Date :||May 2021|
Active Comparator: Varicocele embolization before IVF
Participants will have catheterization and embolization of varicoceles six months before beginning IVF
Procedure: Varicocele embolization
Ultrasound guided right internal jugular vein access with placement of a vascular sheath. Fluoroscopically guided selective catheterization of the left and right (if bilateral) spermatic veins to the level of the inguinal ligament. Occlusion of the spermatic vein(s) by embolization coils and a sclerosing agent (sodium tetradecyl sulphate 3%).
No Intervention: IVF without varicocele embolization
Participants will proceed from enrollment directly to IVF
- Live birth rate [ Time Frame: 25 months ]The percentage of embryo transfers resulting in a live birth
- Pregnancy rate [ Time Frame: 18 months ]The percentage of embryo transfers resulting in a clinical pregnancy ((ultrasound visualization of a gestational sac with heartbeat)
- Transfers per clinical pregnancy [ Time Frame: 18 months ]Total transfers divided by total clinical pregnancies (excluding natural pregnancies) for each study group
- Transfers per live birth [ Time Frame: 25 months ]Total transfers divided by total live births (excluding natural pregnancies) for each study group
- Ongoing pregnancy rate [ Time Frame: 18 months ]Number of pregnancies (including natural) at 3 month time intervals
- Ongoing live birth rate [ Time Frame: 25 months ]Number of live births (including natural) at 3 month time intervals
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03090438
|Contact: Anthony G Verstandig, MD||972 firstname.lastname@example.org|
|Contact: Ruth Ronn, MD||972 549964878||RuthRonn@gmail.com|
|Principal Investigator:||Anthony G Verstandig, MD||C|
|Principal Investigator:||Ruth Ronn, MD||V|