A Prospective, Multi-Centre, Randomized Controlled Study Comparing Varicocelectomy to Observation in Infertile Men With Clinical Varicoceles
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 300
- 试验地点
- 8
- 主要终点
- Pregnancy rates in infertile couples 6 months after surgery or observation alone
研究概览
简要总结
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.
详细描述
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:
- Primary Question:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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)
研究组 & 干预措施
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
干预措施: Varicocelectomy (Procedure)
结局指标
主要结局
Pregnancy rates in infertile couples 6 months after surgery or observation alone
时间窗: 7 months after randomization
次要结局
- 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)