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IVF Outcomes After Varicocele Repair

Sponsor
Shaare Zedek Medical Center (Other)
Overall Status
Unknown status
CT.gov ID
NCT03090438
Collaborator
(none)
250
Enrollment
2
Arms
48
Anticipated Duration (Months)

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Varicocele embolization
 N/A

Detailed 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

Study Type:
Interventional
Anticipated Enrollment :
250 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
The Effect of Preliminary Varicocele Repair on IVF Outcomes in Male Factor Infertility
Anticipated Study Start Date :
May 1, 2017
Anticipated Primary Completion Date :
May 1, 2020
Anticipated Study Completion Date :
May 1, 2021

Arms and Interventions

Arm Intervention/Treatment
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%).
Other Names:
  • Varicocele repair
  • Varicocele occlusion

    		•
    No Intervention: IVF without varicocele embolization

    Participants will proceed from enrollment directly to IVF

    Outcome Measures

    Primary Outcome Measures

    1. Live birth rate [25 months]

      The percentage of embryo transfers resulting in a live birth

    Secondary Outcome Measures

    1. Pregnancy rate [18 months]

      The percentage of embryo transfers resulting in a clinical pregnancy ((ultrasound visualization of a gestational sac with heartbeat)

    2. Transfers per clinical pregnancy [18 months]

      Total transfers divided by total clinical pregnancies (excluding natural pregnancies) for each study group

    3. Transfers per live birth [25 months]

      Total transfers divided by total live births (excluding natural pregnancies) for each study group

    4. Ongoing pregnancy rate [18 months]

      Number of pregnancies (including natural) at 3 month time intervals

    5. Ongoing live birth rate [25 months]

      Number of live births (including natural) at 3 month time intervals

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 35 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    Patient complies to varicocele treatment indications as per ASRM 2014 guidelines

    1. Palpable varicocele on physical exam

    2. The female partner has normal fertility or a potentially treatable cause of infertility

    3. Male has abnormal semen parameters

    Age of female partner < 35 years

    Exclusion Criteria:

    Sub-clinical varicocele

    Isolated teratospermia

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Shaare Zedek Medical Center

    Investigators

    • Principal Investigator: Anthony G Verstandig, MD, C
    • Principal Investigator: Ruth Ronn, MD, V

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Shaare Zedek Medical Center
    ClinicalTrials.gov Identifier:
    NCT03090438
    Other Study ID Numbers:
    • SZMCvarivf
    First Posted:
    Mar 24, 2017
    Last Update Posted:
    Mar 24, 2017
    Last Verified:
    Oct 1, 2016
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Infertility
    Varicocele
    Infertility, Male

    Study Results

    No Results Posted as of Mar 24, 2017