Bilateral versus unilateral vaso - epididymostomy in patients with idiopathic obstructive azosspermia: A prospective randomized trial.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- AIIMS
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- 1.Patency rate (determined by appearance of sperm in the ejaculate), complication rate and operative time after unilateral versus bilateral Vaso-epididymal anastomosis
研究概览
简要总结
Infertility affects 15% of couples in the reproductive age group and the male factors account for about 50% of infertility. Obstruction in the ductal system is one of the treatable causes of azoospermia and microsurgical reconstruction is recommended for obstructions in the vas deferens and epididymis. If epididymal obstruction is present, whether as a primary pathology or as secondary to infection or inflammation, a vasoepididymostomy (VE) is required proximal to the obstruction to restore continuity of sperm transport. Unilateral surgery is associated with lower operative time and complications. Unilateral surgery also preserves the contralateral epididymis for sperm retrieval in case of failure of anastomosis. However, a post-hoc, sub group analysis of our previous data on VE suggested that bilateral VE maybe associated with higher success.
Hypothesis
Bilateral vaso -epididymal anastomosis has better patency rates than unilateral surgery amongst men with idiopathic obstructive azoospermia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 50.00 Year(s)（—）
- 性别
- Male
入选标准
- •1.Clinical examination on patients excluded bilateral vas aplasia.
- •Normal semen volume, presence of fructose and absolute azoospermia was conï¬rmed on at least two semen samples.
- •No patient had had a previous vasectomy, inguinal or scrotal surgery, trauma, or inflammation/infection of the testis.
- •Fine-needle (23 G) aspiration cytology was performed on both testes, the aspirate was stained with Giemsa stain and considered to show ‘normal’ spermatogenesis if the slide revealed many mature sperm 2.Both sides are suitable for surgery 3.Patient willing for bilateral surgery if the randomization chart places him in the bilateral category.
排除标准
- •1.Patients with previous failed vaso- epididymal anastomosis 2.Patients who, during surgery, are found to be not suitable for reconstruction or where the surgery is abandoned.
结局指标
主要结局
1.Patency rate (determined by appearance of sperm in the ejaculate), complication rate and operative time after unilateral versus bilateral Vaso-epididymal anastomosis
时间窗: Patients will be asked to maintain sexual abstinence for 6 weeks. Semen analysis will be done at 6 weeks following surgery followed by repeat analysis at 12 weeks and then at every subsequent 3 months intervals for a follow up period of 12 months or till sperm are seen in the ejaculate, whichever is earlier
次要结局
- 1.Comparison of patients characteristics (age, duration of infertility, FSH and epididymal sperm motility) between the two groups(At the time of randomization)
- 2.Identify factors among bilateral surgery patients which suggest better patency than unilateral surgery(At the time of enrollment)