A Prospective, Randomized, Study of Microsurgical Varicocelectomy Versus Observation in the Treatment of Male Partners With a Palpable Varicocele and an Abnormal Semen Analysis
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 3
- 试验地点
- 9
- 主要终点
- Number of Live Births After Eight Cycles of Infertility Treatment.
研究概览
简要总结
The primary research hypothesis is that microsurgical varicocelectomy will result in an increase in live birth in infertile couples where the male partner has a palpable varicocele and an abnormal semen analysis in comparison to male partners who do not have microsurgical varicocelectomy.
The secondary hypotheses include:
- To assess whether up to 4 cycles of intrauterine insemination confers any additional increase in live birth rates compared to timed intercourse;
- To examine spousal pregnancy rate as the secondary outcome; and
- To study the effect of varicocelectomy in men with infertility, an abnormal semen analysis, and a palpable varicocele on
- Testicular semen analysis parameters;
- Serological measures of FSH, LH, total and free testosterone and
- Measures of quality of life and sexual function in both partners.
详细描述
Study Design
This will be a randomized controlled clinical trial to examine the effect of varicocelectomy in men with infertility, an abnormal semen analysis, and a palpable varicocele. This approach will allow us to compare (i) the effect of microsurgical varicocelectomy on live birth rates after up to four cycles of alternating intrauterine insemination and four cycles of timed intercourse over 8 months and (ii) the relative effectiveness of intrauterine insemination versus timed intercourse on live birth rates. Secondary analyses will explore the effect of the surgical intervention on pregnancy rates, semen analysis parameters, serological hormonal measures in the male subjects, and quality of life measures in both the male and female partners.
Treatment
Two hundred and thirty-two couples will be randomized to the two intervention groups (microsurgical varicocelectomy plus up to four cycles each of alternating intrauterine insemination and timed intercourse or no microsurgical varicocelectomy plus up to four cycles each of alternating intrauterine insemination and timed intercourse).
Timing
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
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •6 months of infertility (primary or secondary - randomization will be stratified to allow equal numbers of primary and secondary infertility couples in the treatment vs. observation group), male partner > 18 years of age and < 50 years of age
- •Female partner > 18 years of age and <= 40 years of age - randomization will be stratified for two groups - female partner <35 and female partner >=35
- •Evidence of a hysterosalpingogram or Saline Infusion Sonogram with one patent tube and regular ovulatory cycles as defined by the recruiting site >25 days and <35 days in duration in the female partner
- •Evidence of a bilateral grade I or unilateral grade II-III varicocele on physical exam in the male partner
- •Abnormal semen analysis as defined by WHO II criteria with a sperm count of >5 X106 /ml or the presence of abnormal strict morphology as defined by Kruger criteria.
排除标准
- •The presence of retrograde ejaculation or uncorrectable ejaculatory dysfunction
- •Decreased ovarian reserve in the female partner as evidence by a day #3 FSH > 12 mIU/ml
研究组 & 干预措施
Surgery + TI
Microsurgical varicocelectomy plus up to four cycles each of alternating intrauterine insemination and timed intercourse starting with timed intercourse.
干预措施: Microsurgical varicocelectomy (Procedure)
Surgery + TI
Microsurgical varicocelectomy plus up to four cycles each of alternating intrauterine insemination and timed intercourse starting with timed intercourse.
干预措施: Intrauterine insemination (Procedure)
No surgery + IUI
No microsurgical varicocelectomy plus up to four cycles each of alternating intrauterine insemination and timed intercourse starting with intrauterine insemination.
干预措施: Timed intercourse (Behavioral)
No surgery + IUI
No microsurgical varicocelectomy plus up to four cycles each of alternating intrauterine insemination and timed intercourse starting with intrauterine insemination.
干预措施: Intrauterine insemination (Procedure)
No Surgery + TI
No microsurgical varicocelectomy plus up to four cycles each of alternating intrauterine insemination and timed intercourse starting with timed intercourse.
干预措施: Timed intercourse (Behavioral)
No Surgery + TI
No microsurgical varicocelectomy plus up to four cycles each of alternating intrauterine insemination and timed intercourse starting with timed intercourse.
干预措施: Intrauterine insemination (Procedure)
Surgery + IUI
Microsurgical varicocelectomy plus up to four cycles each of alternating intrauterine insemination and timed intercourse starting with intrauterine insemination.
干预措施: Timed intercourse (Behavioral)
Surgery + IUI
Microsurgical varicocelectomy plus up to four cycles each of alternating intrauterine insemination and timed intercourse starting with intrauterine insemination.
干预措施: Microsurgical varicocelectomy (Procedure)
Surgery + IUI
Microsurgical varicocelectomy plus up to four cycles each of alternating intrauterine insemination and timed intercourse starting with intrauterine insemination.
干预措施: Intrauterine insemination (Procedure)
Surgery + TI
Microsurgical varicocelectomy plus up to four cycles each of alternating intrauterine insemination and timed intercourse starting with timed intercourse.
干预措施: Timed intercourse (Behavioral)
结局指标
主要结局
Number of Live Births After Eight Cycles of Infertility Treatment.
时间窗: January 2009 to January 2012
次要结局
未报告次要终点
研究者
Heping Zhang
Principal Investigator
Yale University