Evaluation of the Effect of Cervical Occlusion During Infertility Treatment by Intrauterine Insemination
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 93
- 试验地点
- 2
- 主要终点
- Clinical Pregnancy
研究概览
简要总结
Study Hypothesis: There is a difference in pregnancy rates between intrauterine insemination (IUI) in cycles performed with cervical occlusion by a balloon catheter designed for sonohysterograms as compared to those performed with a standard inseminator.
The investigators will compare pregnancy rates in patients undergoing routine IUI either with balloon occlusion or with standard insemination. The patients will receive the standard clinical care per the investigators' office guidelines, except they will be randomized to insemination with either of two catheters.
详细描述
An open speculum will be used and patients will undergo insemination with their partners sperm (same quantity in both arms). If randomized to treatment arm a balloon catheter will be filled with 1cc of air prior to insemination. The speculum will be removed immediately and the catheter will be left in for 15 minutes and then removed. Pregnancy outcomes will be recorded in both groups.
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 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •All patients undergoing IUI for unexplained infertility in our office: Center for Reproduction and Infertility (Providence, RI)
排除标准
- •"Abnormal" Semenalysis TMC < 5 million
- •Blocked Fallopian tubes
结局指标
主要结局
Clinical Pregnancy
时间窗: 1 month
positive beta HCG test
次要结局
- Live Birth(9 months)
- Positive Pregnancy Test(14 days)
研究者
Andrew Blazar, M.D.
Prinicpal Investigator
Women and Infants Hospital of Rhode Island