Stress Management for Couples With Infertility Undergoing In Vitro Fertilization (IVF)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Change of Scores from questionnaires from baseline to 6 and then 12 weeks
研究概览
简要总结
The investigators are trying to determine stress management strategies in couples undergoing In Vitro Fertilization (IVF).
详细描述
The investigators are trying to determine two different stress management techniques in couples undergoing IVF. One arm will be randomized to learning these techniques by themselves by watching and following instructions on a digital video disc (DVD). The other arm will have an in-person class that will teach the couples different stress reduction techniques.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 39 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Women with clinical infertility, either primary or secondary, who are recommended for IVF for the first time as part of their treatment for infertility
- •Women with a partner, and both are willing to provide consent for study participation as a couple
- •Couples that can be reached by telephone for follow-up
排除标准
- •Women less than 18 years of age
- •Women equal or greater than 40 years of age
- •Women with a history of recurrent pregnancy loss
- •History of current or recent psychotic episode within past 6 months for either the woman or her partner
- •Couples needing a interpreter for their clinical encounter
结局指标
主要结局
Change of Scores from questionnaires from baseline to 6 and then 12 weeks
时间窗: Baseline, 6 and 12 weeks after randomization
Primary outcome measure will be comparison of pre- and post-stress reduction treatment questionnaire scale scores.
次要结局
- Clinical Pregnancy rate(12 months after randomization)
研究者
Amit Sood
Associate Professor of Medicine, Consultant - General Internal Medicine
Mayo Clinic