Ignite Creation Date:
2024-05-05 @ 11:54 AM
Last Modification Date:
2024-10-26 @ 9:15 AM
Study NCT ID:
NCT00161395
Status:
COMPLETED
Last Update Posted:
2008-05-16
First Post:
2005-09-08
Brief Title:
Study of Time to Pregnancy in Normal Fertility
Sponsor:
University of Utah
Organization:
University of Utah
Study Overview
Official Title:
Randomized Trial of Fertility Awareness and Time to Pregnancy in Couples of Normal Fertility
Status:
COMPLETED
Status Verified Date:
2005-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Detailed Description:
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 couples 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None