Male Infertility Clinical Trial
Official title:
A Prospective, Multi-Centre, Randomized Controlled Study Comparing Varicocelectomy to Observation in Infertile Men With Clinical Varicoceles
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.
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
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