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

This study has been terminated.
Sponsor:
Collaborators:
McGill University
Dalhousie University
McMaster University
Information provided by:
Mount Sinai Hospital, Canada
ClinicalTrials.gov Identifier:
NCT00961558
First received: August 17, 2009
Last updated: May 24, 2012
Last verified: August 2011
  Purpose

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 Intervention
Male Infertility
Varicoceles
Procedure: Varicocelectomy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Prospective, Multi-Centre, Randomized Controlled Study Comparing Varicocelectomy to Observation in Infertile Men With Clinical Varicoceles

Resource links provided by NLM:


Further study details as provided by Mount Sinai Hospital, Canada:

Primary Outcome Measures:
  • Pregnancy rates in infertile couples 6 months after surgery or observation alone [ Time Frame: 7 months after randomization ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 300
Arms Assigned Interventions
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
Varicocelectomy
Other Names:
  • Microsurgical inguinal varicocelectomy
  • Sub-inguinal varicocelectomy

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   20 Years to 65 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00961558

Locations
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; St. Mary Hospital Centre
Montreal, Quebec, Canada, H3T 1M5
McGill University Health Centre; Royal Victoria Hospital
Montreal, Quebec, Canada, H3A 1A1
Sponsors and Collaborators
Mount Sinai Hospital, Canada
McGill University
Dalhousie University
McMaster University
Investigators
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
  More Information

No publications provided

Responsible Party: Dr. Keith Jarvi, Mount Sinai Hospital, Toronto, Canada
ClinicalTrials.gov Identifier: NCT00961558     History of Changes
Other Study ID Numbers: CAN-888
Study First Received: August 17, 2009
Last Updated: May 24, 2012
Health Authority: Canada: Ethics Review Committee

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

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

ClinicalTrials.gov processed this record on August 26, 2014