Study of Time to Pregnancy in Normal Fertility

Phase 2

Completed

• Conditions: Fertility; Pregnancy
• Interventions: Behavioral: Preconception advice; Behavioral: Instruction in the Creighton Model Fertility Care System

• Registration Number: NCT00161395
• Lead Sponsor: University of Utah

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 Timeline

• Study Start: 2003-01
• Status Verified: 2005-09
• Study First Submitted: 2005-09-08
• Study First Submitted QC: 2005-09-08
• Study First Posted: 2005-09-12
• Primary Completion: 2006-08
• Study Completion: 2007-03
• Last Update Submitted: 2008-05-14
• Last Update Posted: 2008-05-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 143

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	Preconception advice	Preconception advice.
2	Instruction in the Creighton Model Fertility Care System	Instruction in the Creighton Model Fertility Care System.

Primary Outcome Measures

Name	Time	Method
Time to Pregnancy	Up to one year.

Secondary Outcome Measures

Name	Time	Method
Distribution of coitus within "fertile" days of menstrual cycle	Seven menstrual cycles.

Trial Locations

Locations (1)

University of Utah, Dept. Family and Preventive Medicine; 🇺🇸 Salt Lake City, Utah, United States