Clinical Trials Logo

Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00961558
Other study ID # CAN-888
Secondary ID
Status Terminated
Phase N/A
First received August 17, 2009
Last updated May 24, 2012

Study information

Verified date August 2011
Source Mount Sinai Hospital, Canada
Contact n/a
Is FDA regulated No
Health authority Canada: Ethics Review Committee
Study type Interventional

Clinical Trial 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.


Description:

INTRODUCTION:

A varicocele is the most common detectable factor in infertile men (found in approximately 40% of men with infertility) and varicocelectomy is the most commonly performed surgery to treat male infertility. Despite a large body of literature demonstrating a beneficial effect of varicocele repair on male fertility potential, there is significant controversy about the true effects of varicocelectomy mainly due to the paucity of randomized trials. The present controversy has led many clinicians to dismiss the diagnosis (varicocele) altogether and instead, offer alternative treatments to the couple. These alternative therapies include a variety of unnatural, invasive and costly assisted reproductive techniques such as in vitro fertilization. In-vitro fertilization is in widespread use in the world: in 2002 over 117,000 IVF cycles were performed in the USA with over 1% of newborns in that country being conceived with IVF. One of the major indications for the use of IVF is male factor infertility. The number of infertile couples (in whom the man has a varicocele) presently treated with assisted reproduction is unknown, but is probably at least as high as that undergoing varicocelectomy. Approximately 4500 varicocele repairs are performed in Canada yearly (reference: Canadian Health Institute).

The investigators propose a randomized controlled trial on the surgical treatment of clinically detected varicoceles to determine if varicocelectomy results in improved fertility compared to observation alone. This will answer the question about the utility and the role of varicocelectomy in the management of infertile men with a varicocele.

RESEARCH QUESTIONS:

1. Primary Question:

Among infertile men with clinically detectable varicoceles, does varicocelectomy improve the pregnancy rate over a 6-month period compared to observation alone?

2. Secondary Questions:

1. Among infertile men with clinically detectable varicoceles, does varicocelectomy improve sperm parameters (concentration, motility, DNA integrity) over a 6-month period compared to observation alone?

2. Among infertile men with clinically detectable varicoceles, does varicocelectomy increase serum testosterone levels over a 6-month period compared to observation alone?

3. What is the rate of post-operative complications (recurrence, clinical hydrocele formation and testicular atrophy) after varicocelectomy?

4. What is the average time (days) off work after varicocelectomy?

DESIGN ARCHITECTURE:

The investigators propose to conduct a multi-centered, randomized controlled trial comparing varicocelectomy to observation alone in infertile men with moderate to large, clinically detectable varicocele.

ACCRUAL AND DURATION OF STUDY:

To identify a 10% difference in pregnancy rates between the varicocelectomy and control groups we will enroll a total of 300 men (randomized to immediate surgical varicocelectomy or observation alone) and follow these men for 6 months. We anticipate that we will complete recruitment in 3 years. Limiting the study to 6 (rather than 12) months will encourage more couples to participate and is ethically responsible in an era where effective alternative therapies (e.g. IVF) are available.

SIGNIFICANCE:

The demonstration that varicocelectomy is superior, or not, to observation alone will have a great impact on the treatment of male infertility and on the treatment of the infertile couple as a whole. In addition, the results of this study would have a tremendous financial impact on Canadian Health Care. The results would allow for appropriate use of present treatments and resources for at least 10,000 couples annually in Canada. The results of this study would also impact on the management of infertile couples worldwide.


Recruitment information / eligibility

Status Terminated
Enrollment 300
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Male
Age group 20 Years to 65 Years
Eligibility 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)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment


Intervention

Procedure:
Varicocelectomy
Varicocelectomy

Locations

Country Name City State
Canada Queen Elizabeth II Health Sciences Centre Halifax Nova Scotia
Canada McGill University Health Centre; Royal Victoria Hospital Montreal Quebec
Canada McGill University; St. Mary Hospital Centre Montreal Quebec
Canada Mount Sinai Hospital Toronto Ontario

Sponsors (4)

Lead Sponsor Collaborator
Mount Sinai Hospital, Canada Dalhousie University, McGill University, McMaster University

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Pregnancy rates in infertile couples 6 months after surgery or observation alone 7 months after randomization No
Secondary 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 No
See also
  Status Clinical Trial Phase
Recruiting NCT05503862 - Home Semen Testing in Men Beginning Attempts to Conceive N/A
Recruiting NCT03307655 - Relationship Between Nitric Oxide (NO) in Follicular Fluid and Sperm Fertilization Ability N/A
Withdrawn NCT02839447 - A Clinical Evaluation of Semen Quality Using the MiOXSYS™ System 2.0
Completed NCT00975117 - Spermotrend in the Treatment of Male Infertility Phase 3
Completed NCT00756561 - HOP-2A - Intratesticular Hormone Levels N/A
Recruiting NCT04541459 - Validation of New Devices Against Ambient Electromagnetic Radiation Early Phase 1
Completed NCT02889341 - Valuation of Variable Dose of Docosahexanoic Acid for the Improvement of the Parameters of Male Fertility N/A
Not yet recruiting NCT03167008 - Vitamin D Level vs Semen Parameters
Completed NCT02268123 - Correlating In Vitro Fertilization Outcomes After Euploid Blastocyst Transfer With Sperm DNA Fragmentation
Completed NCT01232465 - Impact of Sperm DNA Integrity on In Vitro Cycles N/A
Recruiting NCT00119925 - 'SPRING'-Study: "Subfertility Guidelines: Patient Related Implementation in the Netherlands Among Gynaecologists" N/A
Completed NCT03552081 - Tobacco and Sperm Genome: Effects of Smoking Cessation N/A
Recruiting NCT05200663 - Efficacy Comparison of Tamoxifen and Tamoxifen With Antioxidants on Semen Quality of Male With Idiopathic Infertility Phase 2
Completed NCT02025270 - MSCs For Treatment of Azoospermic Patients Phase 1/Phase 2
Recruiting NCT06147700 - Identifying Molecular Determinants of Infertility in Men (MODIFY)
Recruiting NCT06188936 - Home Semen Analysis Tests as a Screening Tool for Fertility Patients N/A
Recruiting NCT04200118 - Epigenetic and Genetic Effects in Cancer Patients: Analysis Pre and After Treatment
Terminated NCT02605070 - Pilot Study on the Effects of FSH Treatment on the Epigenetic Characteristics of Spermatozoa in Infertile Patients With Severe Oligozoospermia Phase 3
Completed NCT01407432 - Impact of Folates in the Care of the Male Infertility Phase 3
Completed NCT00596739 - A Study of the Pre- and Post-operative Semen Analyses and Reproductive Hormone Levels of Men Undergoing Weight-reduction Surgery N/A