Study of Time to Pregnancy in Normal Fertility

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00161395

Enrollment

143

Registered

2005-09-12

Start date

2003-01-31

Completion date

2007-03-31

Last updated

2008-05-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fertility, Pregnancy

Keywords

fertility, pregnancy

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.

Interventions

BEHAVIORALInstruction in the Creighton Model Fertility Care System

Instruction in the Creighton Model Fertility Care System.

BEHAVIORALPreconception advice

Preconception advice for diet and frequency of intercourse.

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 35 Years

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

Design outcomes

Primary

Measure	Time frame
Time to Pregnancy	Up to one year.

Secondary

Measure	Time frame
Distribution of coitus within fertile days of menstrual cycle	Seven menstrual cycles.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 19, 2026