NCT00449449已完成2 期
A Randomised, Open, Controlled, Parallel Group, Multi-Centre Phase II Clinical Study of Lidocain Pertubation as Treatment for Couples With Unexplained Infertility
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Isifer AB
- 入组人数
- 330
- 试验地点
- 2
- 主要终点
- clinical pregnancy
研究概览
简要总结
The study tested the hypothesis that a pertubation with a lidocain solution will enhance pregnancy rate.
详细描述
In a prospective study, patients were randomized during a clomiphene citrate stimulated cycle to either pertubation with low-dose lidocain or no pertubation before insemination.
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
- 20 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •20-40 years of age,
- •If presence of peritoneal endometriosis they must be of minimal or mild without adhesions (verified by laparoscopy),
- •Normal menstruation cycle,
- •Male partner 20-70 years of age,
- •Male partner,
- •Normal sperm sample within 5 years (>20x106/mL, total sperm count >30x106, normal morphology 5%),
- •Duration of infertility more than one year,
- •Signed informed consent
排除标准
- •Treatment with NSAID, corticosteroids or other drugs, which can cause an increased risk of infection,
- •Clinical signs of PID,
- •Known hypersensitivity to local anesthetics,
- •Non-patent fallopian tubes,
- •Pathological uterine cavity,
- •Pathological PCT, myoma > 2 cm diameter,
- •Any disease or laboratory finding considered of importance by the investigator not to include the patient
结局指标
主要结局
clinical pregnancy
次要结局
- Pregnancy rate measured by Serum-HCG day 17 after IUI
研究者
研究点 (2)
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