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

NCT00961558 | Terminated DMC

• 1 other identifier: CAN-888
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 4

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.

Conditions

Male Infertility; Varicoceles

Keywords

varicocelectomy; male infertility; clinical varicoceles; randomized control trial

Outcome Measures

Primary Outcomes (1)

• Pregnancy rates in infertile couples 6 months after surgery or observation alone

  7 months after randomization

Secondary Outcomes (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.

  7 months after randomization

Study Arms (2)

Observation arm

NO INTERVENTION

Patient will not to undergo any form of Assisted Reproductive Technologies for a period of 6 months

Surgery Arm

OTHER

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

Interventions

Varicocelectomy PROCEDURE

Varicocelectomy

Also known as: Microsurgical inguinal varicocelectomy, Sub-inguinal varicocelectomy

Surgery Arm

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Mount Sinai Hospital, Canada: lead
• McGill University: collaborator
• Dalhousie University: collaborator
• McMaster University: collaborator

Study Sites (4)

Queen Elizabeth II Health Sciences Centre

Halifax, Nova Scotia, B3H 2A7, Canada

Location

Mount Sinai Hospital

Toronto, Ontario, M5G 1X5, Canada

Location

McGill University Health Centre; Royal Victoria Hospital

Montreal, Quebec, H3A 1A1, Canada

Location

McGill University; St. Mary Hospital Centre

Montreal, Quebec, H3T 1M5, Canada

Location

MeSH Terms

Conditions

Infertility, Male; Varicocele

Condition Hierarchy (Ancestors)

Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Infertility; Male Urogenital Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Keith A Jarvi, MD

  MOUNT SINAI HOSPITAL

  STUDY CHAIR

• Armand S Zini, MD

  McGill University

  STUDY DIRECTOR

• Kirk C Lo, MD

  MOUNT SINAI HOSPITAL

  PRINCIPAL INVESTIGATOR

• Ethan D Grober, MD

  MOUNT SINAI HOSPITAL

  PRINCIPAL INVESTIGATOR

• Peter T Chan, MD

  McGill University

  PRINCIPAL INVESTIGATOR

• John E Grantmyre, MD

  Dalhousie University

  PRINCIPAL INVESTIGATOR

• Edward G Hughes, MD

  McMaster University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 17, 2009
• First Posted: August 19, 2009
• Last Updated: May 28, 2012

Record last verified: 2011-08

Locations

CA (4)