NCT02695199Unknown不适用
Comparison Between Laparoscopic Doppler Ultrasound Assisted Laparoscopic Varicocelectomy and Microscopic Subinguinal Varicocelectomy
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Pregnancy rate
研究概览
简要总结
To evaluate the benefits of laparoscopic Doppler ultrasound (LDU) assisted laparoscopic varicocelectomy (LV) and compare the surgical outcomes and complications between LDU assisted LV (LDU-LV) and microscopic subinguinal varicocelectomy for infertile patients with varicoceles.
详细描述
To compare the surgical outcomes such as semen parameters and the pregnancy rate and complications like postoperative varicocele recurrence and hydrocele between laparoscopic Doppler ultrasound assisted laparoscopic varicocelectomy and conventional microscopic subinguinal for infertile patients with varicoceles. To examine the microanatomy of the spermatic cord within suprainguinal portion.
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
- Double (Care Provider, Investigator)
入排标准
- 年龄范围
- 20 Years 至 39 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •20-39 years old who had infertility for more than 1 year and had clinical palpable varicoceles;
- •impaired semen quality including sperm concentration <15 million/ml or total motility <40% or progressively motile < 32% (a+b), the 5th edited World Health Organization criteria was referred;
- •with normal level of serum hormones including follicle stimulating hormone, luteinizing hormone, Thyroid hormones and prolactin;
- •patient's spouse was healthy in reproduction.
排除标准
- •with subclinical varicocele, recurrent varicoceles;
- •normal semen analyses;
- •other reasons of infertility than varicoceles;
- •refusing to enter randomization;
- •female partner older than 35 years;
- •with abnormal level of serum hormones;
- •female factor infertility;
- •with significant surgical diseases, congenital diseases or endocrine diseases.
结局指标
主要结局
Pregnancy rate
时间窗: The pregnancy rate was calculated at 1 year of follow-up
次要结局
- semen quality assessment(semen quality assessment were checked at 3, 6 and 12 months after surgery.)
- postoperative complications(postoperative complications at 3, 6 and 12 months after surgery)
研究者
研究点 (1)
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