Study of Time to Pregnancy in Normal Fertility
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | September 8, 2005 | ||||
| Last Updated Date | May 14, 2008 | ||||
| Start Date ICMJE | January 2003 | ||||
| Primary Completion Date | August 2006 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Time to Pregnancy [ Time Frame: Up to one year. ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE |
Time to Pregnancy | ||||
| Change History | Complete list of historical versions of study NCT00161395 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
Distribution of coitus within "fertile" days of menstrual cycle [ Time Frame: Seven menstrual cycles. ] [ Designated as safety issue: No ] | ||||
| Original Secondary Outcome Measures ICMJE |
Distribution of coitus within "fertile" days of menstrual cycle | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Study of Time to Pregnancy in Normal Fertility | ||||
| Official Title ICMJE | Randomized Trial of Fertility Awareness and Time to Pregnancy in Couples of Normal Fertility | ||||
| 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 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. |
||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 2 | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label |
||||
| Condition ICMJE |
|
||||
| Intervention ICMJE |
|
||||
| Study Arm (s) |
|
||||
| Publications * | Not Provided | ||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||
| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 143 | ||||
| Completion Date | March 2007 | ||||
| Primary Completion Date | August 2006 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
|
||||
| Gender | Female | ||||
| Ages | 18 Years to 35 Years | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00161395 | ||||
| Other Study ID Numbers ICMJE | K23 HD1479 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Joseph Stanford, M.D., Principal Investigator, University of Utah | ||||
| Study Sponsor ICMJE | University of Utah | ||||
| Collaborators ICMJE | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | ||||
| Investigators ICMJE |
|
||||
| Information Provided By | University of Utah | ||||
| Verification Date | September 2005 | ||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||||