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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
Sponsor:
Information provided by (Responsible Party):
Shaare Zedek Medical Center

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
Infertility, Male Varicocele In Vitro Fertilization Procedure: Varicocele embolization Not Applicable

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 Type : Interventional  (Clinical Trial)
Estimated 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
Estimated Study Start Date : May 2017
Estimated Primary Completion Date : May 2020
Estimated Study Completion Date : May 2021


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



Primary Outcome Measures :
  1. Live birth rate [ Time Frame: 25 months ]
    The percentage of embryo transfers resulting in a live birth


Secondary Outcome Measures :
  1. Pregnancy rate [ Time Frame: 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 [ Time Frame: 18 months ]
    Total transfers divided by total clinical pregnancies (excluding natural pregnancies) for each study group

  3. Transfers per live birth [ Time Frame: 25 months ]
    Total transfers divided by total live births (excluding natural pregnancies) for each study group

  4. Ongoing pregnancy rate [ Time Frame: 18 months ]
    Number of pregnancies (including natural) at 3 month time intervals

  5. Ongoing live birth rate [ Time Frame: 25 months ]
    Number of live births (including natural) at 3 month time intervals



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

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


Information from the National Library of Medicine

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


Contacts
Contact: Anthony G Verstandig, MD 972 508685879 anthonyv@szmc.org.il
Contact: Ruth Ronn, MD 972 549964878 RuthRonn@gmail.com

Sponsors and Collaborators
Shaare Zedek Medical Center
Investigators
Principal Investigator: Anthony G Verstandig, MD C
Principal Investigator: Ruth Ronn, MD V

Publications:

Responsible Party: Shaare Zedek Medical Center
ClinicalTrials.gov Identifier: NCT03090438     History of Changes
Other Study ID Numbers: SZMCvarivf
First Posted: March 24, 2017    Key Record Dates
Last Update Posted: March 24, 2017
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
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
Genital Diseases, Male
Genital Diseases, Female
Vascular Diseases
Cardiovascular Diseases