Pregnancy Clinical Trial
Official title:
Randomized Trial of Fertility Awareness and Time to Pregnancy in Couples of Normal Fertility
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.
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.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label
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