Canadian Varicocelectomy Initiative (CVI): Effects on Male Fertility and Testicular Function of Varicocelectomy (CVI)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00961558
Recruitment Status : Terminated
First Posted : August 19, 2009
Last Update Posted : May 28, 2012
McGill University
Dalhousie University
McMaster University
Information provided by:
Mount Sinai Hospital, Canada

Brief Summary:

A varicocele is the presence of dilated testicular veins in the scrotum. Although it is generally agreed that a varicocele is the most common identifiable pathology in infertile men (detected in up to 40% of men in some series of men with infertility), the influence of a varicocele on male fertility potential and role of varicocelectomy in restoring of fertility remain the subject of ongoing controversy. The present controversy on the effect of varicocelectomy on male fertility potential has led many clinicians to dismiss the diagnosis of a varicocele altogether and instead, offer alternative treatments to the couple. Many of these alternative therapies are expensive and risky for the patients and their children. Several recent reviews have critically examined the results of randomized, controlled trials of varicocelectomy on fertility potential. The effect of varicocelectomy on spontaneous pregnancy rates remains controversial.

The investigators hypothesize that a varicocelectomy will result in a significant improvement in fertility and testicular function in infertile men with a clinical varicocele.

Condition or disease Intervention/treatment Phase
Male Infertility Varicoceles Procedure: Varicocelectomy Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Prospective, Multi-Centre, Randomized Controlled Study Comparing Varicocelectomy to Observation in Infertile Men With Clinical Varicoceles

Arm Intervention/treatment
No Intervention: Observation arm
Patient will not to undergo any form of Assisted Reproductive Technologies for a period of 6 months
Surgery Arm
Patients will have varicocelectomy within 1 month of assessment and will not undergo any form of Assisted Reproductive Technologies for a period of 6 months after surgery
Procedure: Varicocelectomy
Other Names:
  • Microsurgical inguinal varicocelectomy
  • Sub-inguinal varicocelectomy

Primary Outcome Measures :
  1. Pregnancy rates in infertile couples 6 months after surgery or observation alone [ Time Frame: 7 months after randomization ]

Secondary Outcome Measures :
  1. Mean improvements in sperm parameters, serum testosterone levels 6 months after surgery or observation alone; complication rate after varicocelectomy; mean time (days) off work after varicocelectomy. [ Time Frame: 7 months after randomization ]

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Ages Eligible for Study:   20 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Minimum of one year of infertility
  • Clinically detectable grade 2 or grade 3 varicocele
  • A minimum of 2 abnormal semen analyses (defined as < 20 million sperm/ml, and/or < 30% progressive motility and/or normal sperm morphology < 14% by Kruger Strict Morphology (WHO) within 6 months of entry into the study)
  • Female partner < 38 years of age

Exclusion Criteria:

  • Other medically correctable cause of infertility (e.g., prolactinoma, infection, exposure to marijuana)
  • Severe oligospermia on 2 sperm analyses (defined as < 5 million sperm/ml)
  • Severe asthenospermia on 2 sperm analyses (< 5% progressive motility)
  • Prior varicocele repair
  • Solitary testicle
  • Significant female-factor infertility (tubal factor or anovulation only)
  • Inability or unwillingness to comply with study protocol (including failure to submit 2 post-intervention semen samples)

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 identifier (NCT number): NCT00961558

Canada, Nova Scotia
Queen Elizabeth II Health Sciences Centre
Halifax, Nova Scotia, Canada, B3H 2A7
Canada, Ontario
Mount Sinai Hospital
Toronto, Ontario, Canada, M5G 1X5
Canada, Quebec
McGill University Health Centre; Royal Victoria Hospital
Montreal, Quebec, Canada, H3A 1A1
McGill University; St. Mary Hospital Centre
Montreal, Quebec, Canada, H3T 1M5
Sponsors and Collaborators
Mount Sinai Hospital, Canada
McGill University
Dalhousie University
McMaster University
Study Chair: Keith A Jarvi, MD Mount Sinai Hospital, New York
Study Director: Armand S Zini, MD McGill University
Principal Investigator: Kirk C Lo, MD Mount Sinai Hospital, New York
Principal Investigator: Ethan D Grober, MD Mount Sinai Hospital, New York
Principal Investigator: Peter T Chan, MD McGill University
Principal Investigator: John E Grantmyre, MD Dalhousie University
Principal Investigator: Edward G Hughes, MD McMaster University

Responsible Party: Dr. Keith Jarvi, Mount Sinai Hospital, Toronto, Canada Identifier: NCT00961558     History of Changes
Other Study ID Numbers: CAN-888
First Posted: August 19, 2009    Key Record Dates
Last Update Posted: May 28, 2012
Last Verified: August 2011

Keywords provided by Mount Sinai Hospital, Canada:
male infertility
clinical varicoceles
randomized control trial

Additional relevant MeSH terms:
Infertility, Male
Genital Diseases, Male
Genital Diseases, Female
Vascular Diseases
Cardiovascular Diseases