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

2014-07-24 14:11:48 | BioPortfolio

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.

Study Design

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

Conditions

Male Infertility

Intervention

Varicocelectomy

Location

Queen Elizabeth II Health Sciences Centre
Halifax
Nova Scotia
Canada
B3H 2A7

Status

Recruiting

Source

Mount Sinai Hospital, Canada

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-24T14:11:48-0400

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PubMed Articles [3867 Associated PubMed Articles listed on BioPortfolio]

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Infertility occurs in 10-15% of couples worldwide and close to half of it is caused by male factors. One of the genes that can affect male infertility is CGA. Polymorphisms in CGA gene may affect gene...

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Medical and Biotech [MESH] Definitions

The inability of the male to effect FERTILIZATION of an OVUM after a specified period of unprotected intercourse. Male sterility is permanent infertility.

An assisted fertilization technique consisting of the microinjection of a single viable sperm into an extracted ovum. It is used principally to overcome low sperm count, low sperm motility, inability of sperm to penetrate the egg, or other conditions related to male infertility (INFERTILITY, MALE).

A form of male HYPOGONADISM, characterized by the presence of an extra X CHROMOSOME, small TESTES, seminiferous tubule dysgenesis, elevated levels of GONADOTROPINS, low serum TESTOSTERONE, underdeveloped secondary sex characteristics, and male infertility (INFERTILITY, MALE). Patients tend to have long legs and a slim, tall stature. GYNECOMASTIA is present in many of the patients. The classic form has the karyotype 47,XXY. Several karyotype variants include 48,XXYY; 48,XXXY; 49,XXXXY, and mosaic patterns ( 46,XY/47,XXY; 47,XXY/48,XXXY, etc.).

A scientific or medical discipline concerning the study of male reproductive biology, diseases of the male genital organs, and male infertility. Major areas of interest include ENDOCRINOLOGY; SPERMATOGENESIS; semen analysis; FERTILIZATION; CONTRACEPTION; and CRYOPRESERVATION.

Inability to reproduce after a specified period of unprotected intercourse. Reproductive sterility is permanent infertility.

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