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IVF Outcomes After Varicocele Repair

Primary Purpose

Infertility, Male, Varicocele, In Vitro Fertilization

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Varicocele embolization
Sponsored by
Shaare Zedek Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Infertility, Male

Eligibility Criteria

18 Years - 35 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    No Intervention

    Arm Label

    Varicocele embolization before IVF

    IVF without varicocele embolization

    Arm Description

    Participants will have catheterization and embolization of varicoceles six months before beginning IVF

    Participants will proceed from enrollment directly to IVF

    Outcomes

    Primary Outcome Measures

    Live birth rate
    The percentage of embryo transfers resulting in a live birth

    Secondary Outcome Measures

    Pregnancy rate
    The percentage of embryo transfers resulting in a clinical pregnancy ((ultrasound visualization of a gestational sac with heartbeat)
    Transfers per clinical pregnancy
    Total transfers divided by total clinical pregnancies (excluding natural pregnancies) for each study group
    Transfers per live birth
    Total transfers divided by total live births (excluding natural pregnancies) for each study group
    Ongoing pregnancy rate
    Number of pregnancies (including natural) at 3 month time intervals
    Ongoing live birth rate
    Number of live births (including natural) at 3 month time intervals

    Full Information

    First Posted
    March 20, 2017
    Last Updated
    March 23, 2017
    Sponsor
    Shaare Zedek Medical Center
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03090438
    Brief Title
    IVF Outcomes After Varicocele Repair
    Official Title
    The Effect of Preliminary Varicocele Repair on IVF Outcomes in Male Factor Infertility
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2016
    Overall Recruitment Status
    Unknown status
    Study Start Date
    May 2017 (Anticipated)
    Primary Completion Date
    May 2020 (Anticipated)
    Study Completion Date
    May 2021 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Shaare Zedek Medical Center

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. 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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Infertility, Male, Varicocele, In Vitro Fertilization

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    250 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Varicocele embolization before IVF
    Arm Type
    Active Comparator
    Arm Description
    Participants will have catheterization and embolization of varicoceles six months before beginning IVF
    Arm Title
    IVF without varicocele embolization
    Arm Type
    No Intervention
    Arm Description
    Participants will proceed from enrollment directly to IVF
    Intervention Type
    Procedure
    Intervention Name(s)
    Varicocele embolization
    Other Intervention Name(s)
    Varicocele repair, Varicocele occlusion
    Intervention Description
    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%).
    Primary Outcome Measure Information:
    Title
    Live birth rate
    Description
    The percentage of embryo transfers resulting in a live birth
    Time Frame
    25 months
    Secondary Outcome Measure Information:
    Title
    Pregnancy rate
    Description
    The percentage of embryo transfers resulting in a clinical pregnancy ((ultrasound visualization of a gestational sac with heartbeat)
    Time Frame
    18 months
    Title
    Transfers per clinical pregnancy
    Description
    Total transfers divided by total clinical pregnancies (excluding natural pregnancies) for each study group
    Time Frame
    18 months
    Title
    Transfers per live birth
    Description
    Total transfers divided by total live births (excluding natural pregnancies) for each study group
    Time Frame
    25 months
    Title
    Ongoing pregnancy rate
    Description
    Number of pregnancies (including natural) at 3 month time intervals
    Time Frame
    18 months
    Title
    Ongoing live birth rate
    Description
    Number of live births (including natural) at 3 month time intervals
    Time Frame
    25 months

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    35 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Patient complies to varicocele treatment indications as per ASRM 2014 guidelines Palpable varicocele on physical exam The female partner has normal fertility or a potentially treatable cause of infertility Male has abnormal semen parameters Age of female partner < 35 years Exclusion Criteria: Sub-clinical varicocele Isolated teratospermia
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Anthony G Verstandig, MD
    Phone
    972 508685879
    Email
    anthonyv@szmc.org.il
    First Name & Middle Initial & Last Name or Official Title & Degree
    Ruth Ronn, MD
    Phone
    972 549964878
    Email
    RuthRonn@gmail.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Anthony G Verstandig, MD
    Organizational Affiliation
    C
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Ruth Ronn, MD
    Organizational Affiliation
    V
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    8458466
    Citation
    Gorelick JI, Goldstein M. Loss of fertility in men with varicocele. Fertil Steril. 1993 Mar;59(3):613-6.
    Results Reference
    background
    PubMed Identifier
    17905111
    Citation
    Agarwal A, Deepinder F, Cocuzza M, Agarwal R, Short RA, Sabanegh E, Marmar JL. Efficacy of varicocelectomy in improving semen parameters: new meta-analytical approach. Urology. 2007 Sep;70(3):532-8. doi: 10.1016/j.urology.2007.04.011.
    Results Reference
    background
    PubMed Identifier
    21435155
    Citation
    Diegidio P, Jhaveri JK, Ghannam S, Pinkhasov R, Shabsigh R, Fisch H. Review of current varicocelectomy techniques and their outcomes. BJU Int. 2011 Oct;108(7):1157-72. doi: 10.1111/j.1464-410X.2010.09959.x. Epub 2011 Mar 24.
    Results Reference
    background
    PubMed Identifier
    25523457
    Citation
    Verstandig AG, Shamieh B, Shraibman V, Raveh D. Radiation dose reduction in fluoroscopic procedures: left varicocele embolization as a model. Eur Radiol. 2015 Jun;25(6):1639-45. doi: 10.1007/s00330-014-3556-4. Epub 2014 Dec 19.
    Results Reference
    background
    PubMed Identifier
    26510504
    Citation
    Esteves SC, Roque M, Agarwal A. Outcome of assisted reproductive technology in men with treated and untreated varicocele: systematic review and meta-analysis. Asian J Androl. 2016 Mar-Apr;18(2):254-8. doi: 10.4103/1008-682X.163269.
    Results Reference
    background
    PubMed Identifier
    24175046
    Citation
    Kim KH, Lee JY, Kang DH, Lee H, Seo JT, Cho KS. Impact of surgical varicocele repair on pregnancy rate in subfertile men with clinical varicocele and impaired semen quality: a meta-analysis of randomized clinical trials. Korean J Urol. 2013 Oct;54(10):703-9. doi: 10.4111/kju.2013.54.10.703. Epub 2013 Oct 15.
    Results Reference
    background
    PubMed Identifier
    22425089
    Citation
    Schauer I, Madersbacher S, Jost R, Hubner WA, Imhof M. The impact of varicocelectomy on sperm parameters: a meta-analysis. J Urol. 2012 May;187(5):1540-7. doi: 10.1016/j.juro.2011.12.084. Epub 2012 Mar 14.
    Results Reference
    background
    PubMed Identifier
    22979920
    Citation
    Li F, Yamaguchi K, Okada K, Matsushita K, Ando M, Chiba K, Yue H, Fujisawa M. Significant improvement of sperm DNA quality after microsurgical repair of varicocele. Syst Biol Reprod Med. 2012 Oct;58(5):274-7. doi: 10.3109/19396368.2012.692431. Epub 2012 Jul 2.
    Results Reference
    background
    PubMed Identifier
    1601152
    Citation
    The influence of varicocele on parameters of fertility in a large group of men presenting to infertility clinics. World Health Organization. Fertil Steril. 1992 Jun;57(6):1289-93.
    Results Reference
    background

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    IVF Outcomes After Varicocele Repair

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