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| Sponsors and Collaborators: |
University of Utah Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
|---|---|
| Information provided by: | University of Utah |
| ClinicalTrials.gov Identifier: | NCT00161395 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Fertility Pregnancy |
Behavioral: Instruction in the Creighton Model Fertility Care System Behavioral: Preconception advice |
Phase II |
| Study Type: | Interventional |
| Study Design: | Randomized, Open Label, Active Control, Single Group Assignment, Efficacy Study |
| Official Title: | Randomized Trial of Fertility Awareness and Time to Pregnancy in Couples of Normal Fertility |
| Enrollment: | 143 |
| Study Start Date: | January 2003 |
| Study Completion Date: | March 2007 |
| Primary Completion Date: | August 2006 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Active Comparator
Preconception advice.
|
Behavioral: Preconception advice
Preconception advice for diet and frequency of intercourse.
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2: Experimental
Instruction in the Creighton Model Fertility Care System.
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Behavioral: Instruction in the Creighton Model Fertility Care System
Instruction in the Creighton Model Fertility Care System.
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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.
Eligibility| Ages Eligible for Study: | 18 Years to 35 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Utah | |
| University of Utah, Dept. Family and Preventive Medicine | |
| Salt Lake City, Utah, United States, 84108 | |
| Principal Investigator: | Joseph B Stanford, MD | University of Utah |
More Information
| Responsible Party: | University of Utah ( Joseph Stanford, M.D., Principal Investigator ) |
| Study ID Numbers: | K23 HD1479 |
| Study First Received: | September 8, 2005 |
| Last Updated: | May 14, 2008 |
| ClinicalTrials.gov Identifier: | NCT00161395 |
| Health Authority: | United States: Institutional Review Board |
|
fertility pregnancy |
|
Genital Diseases, Female Infertility Genital Diseases, Male |
