Study of Time to Pregnancy in Normal Fertility
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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 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label |
| Official Title: | Randomized Trial of Fertility Awareness and Time to Pregnancy in Couples of Normal Fertility |
- Time to Pregnancy [ Time Frame: Up to one year. ] [ Designated as safety issue: No ]
- Distribution of coitus within "fertile" days of menstrual cycle [ Time Frame: Seven menstrual cycles. ] [ Designated as safety issue: No ]
| 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 |
|---|---|
|
Active Comparator: 1
Preconception advice.
|
Behavioral: Preconception advice
Preconception advice for diet and frequency of intercourse.
|
|
Experimental: 2
Instruction in the Creighton Model Fertility Care System.
|
Behavioral: Instruction in the Creighton Model Fertility Care System
Instruction in the Creighton Model Fertility Care System.
Other Name: Fertility awareness instruction.
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 35 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- couple with prior pregnancy within the past 8 years
Exclusion Criteria:
- any history that suggests subfertility
- any history that suggests a medical contraindication for pregnancy
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
Additional Information:
No publications provided
| Responsible Party: | Joseph Stanford, M.D., Principal Investigator, University of Utah |
| ClinicalTrials.gov Identifier: | NCT00161395 History of Changes |
| Other Study ID Numbers: | K23 HD1479 |
| Study First Received: | September 8, 2005 |
| Last Updated: | May 14, 2008 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of Utah:
|
fertility pregnancy |
Additional relevant MeSH terms:
|
Infertility Genital Diseases, Male Genital Diseases, Female |
ClinicalTrials.gov processed this record on May 16, 2013