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NCT00161395 Clinical Trial

Study of Time to Pregnancy in Normal Fertility

Pregnancy Clinical Trial

Official title:
Randomized Trial of Fertility Awareness and Time to Pregnancy in Couples of Normal Fertility

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00161395
Other study ID # K23HD001479
Secondary ID
Status Completed
Phase Phase 2
First received September 8, 2005
Last updated May 14, 2008
Start date January 2003
Est. completion date March 2007

Study information
Verified date September 2005
Source University of Utah
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 143
Est. completion date March 2007
Est. primary completion date August 2006
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 35 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

Intervention

Behavioral:
• Instruction in the Creighton Model Fertility Care System
Instruction in the Creighton Model Fertility Care System.
• Preconception advice
Preconception advice for diet and frequency of intercourse.

Locations
Country Name City State
United States University of Utah, Dept. Family and Preventive Medicine Salt Lake City Utah

Sponsors (2)
Lead Sponsor Collaborator
University of Utah Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Time to Pregnancy Up to one year. No
Secondary Distribution of coitus within "fertile" days of menstrual cycle Seven menstrual cycles. No
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