Randomized Trial of Fertility Awareness and Time to Pregnancy in Couples of Normal Fertility
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 143
- 试验地点
- 2
- 主要终点
- Time to Pregnancy
研究概览
简要总结
The purpose of this study is to determine how long it takes couples of normal fertility to get pregnant once they begin to try, and whether instruction in fertility awareness can decrease time to pregnancy in these couples.
详细描述
Research has established that there are relatively few days of the menstrual cycle that have a substantial probability of pregnancy from coitus, and that there are prospective biomarkers that allow a woman or couple to identify these "fertile" days. However, it remains unclear how this knowledge may improve a couple's chances of conceiving.
All couples participating in this study must have a history of previous pregnancy together and no history suggesting subfertility. Participants in this study will be randomly assigned to one of two groups. One group will receive instruction about identifying the days when a woman is mostly likely to get pregnant from intercourse, using the Creighton Model FertilityCare System, and the other group will receive instructions about the menstrual cycle, fertility, and preparing for pregnancy. Randomization is stratified by age.
All participants will keep a daily fertility chart and use a computerized device called the Fertility Monitor with urine dipsticks to monitor hormones of the menstrual cycle.
The primary outcome is time to pregnancy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •couple with prior pregnancy within the past 8 years
排除标准
- •any history that suggests subfertility
- •any history that suggests a medical contraindication for pregnancy
结局指标
主要结局
Time to Pregnancy
时间窗: Up to one year.
次要结局
- Distribution of coitus within "fertile" days of menstrual cycle(Seven menstrual cycles.)