NCT00161395

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
143

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jan 2003

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2003

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

September 8, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 12, 2005

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2006

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2007

Completed
Last Updated

May 16, 2008

Status Verified

September 1, 2005

Enrollment Period

3.6 years

First QC Date

September 8, 2005

Last Update Submit

May 14, 2008

Conditions

FertilityPregnancy

Keywords

fertilitypregnancy

Outcome Measures

Primary Outcomes (1)

  • Time to Pregnancy

    Up to one year.

Secondary Outcomes (1)

  • Distribution of coitus within "fertile" days of menstrual cycle

    Seven menstrual cycles.

Study Arms (2)

1

ACTIVE COMPARATOR

Preconception advice.

Behavioral: Preconception advice

2

EXPERIMENTAL

Instruction in the Creighton Model Fertility Care System.

Behavioral: Instruction in the Creighton Model Fertility Care System

Interventions

Instruction in the Creighton Model Fertility Care SystemBEHAVIORAL

Instruction in the Creighton Model Fertility Care System.

Also known as: Fertility awareness instruction.
2
Preconception adviceBEHAVIORAL

Preconception advice for diet and frequency of intercourse.

1

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • couple with prior pregnancy within the past 8 years

You may not qualify if:

  • any history that suggests subfertility
  • any history that suggests a medical contraindication for pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Utah, Dept. Family and Preventive Medicine

Salt Lake City, Utah, 84108, United States

Location

Related Publications (1)

  • Stanford JB, Smith KR, Varner MW. Impact of instruction in the Creighton model fertilitycare system on time to pregnancy in couples of proven fecundity: results of a randomised trial. Paediatr Perinat Epidemiol. 2014 Sep;28(5):391-9. doi: 10.1111/ppe.12141.

    PMID: 25225008DERIVED

MeSH Terms

Interventions

Educational Status

Intervention Hierarchy (Ancestors)

Socioeconomic FactorsPopulation Characteristics

Study Officials

  • Joseph B Stanford, MD

    University of Utah

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 8, 2005

First Posted

September 12, 2005

Study Start

January 1, 2003

Primary Completion

August 1, 2006

Study Completion

March 1, 2007

Last Updated

May 16, 2008

Record last verified: 2005-09

Locations

US(1)