Skip to main content
OpenTrials
Completed

NCT Number: NCT00161395

Study of Time to Pregnancy in Normal Fertility

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Fertility Pregnancy

Age range

18 year–35 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

University of Utah, Dept. Family and Preventive Medicine

Salt Lake City, Utah, 84108, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Instruction in the Creighton Model Fertility Care System

Behavioral

Instruction in the Creighton Model Fertility Care System.

Other names: Fertility awareness instruction.

Preconception advice

Behavioral

Preconception advice for diet and frequency of intercourse.

Primary outcomes

  1. Time to Pregnancy

    Time frame: Up to one year.

Secondary outcomes

  1. Distribution of coitus within "fertile" days of menstrual cycle

    Time frame: Seven menstrual cycles.

Sponsors and collaborators

Lead sponsor

University of Utah

Other

Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Registry information

Official study title

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

Important dates

Study start
2003
Primary completion
2006
Study completion
2007
First posted
Sep 12, 2005
Registry last updated
May 16, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.