Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Study of Time to Pregnancy in Normal Fertility

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
University of Utah
ClinicalTrials.gov Identifier:
NCT00161395
First received: September 8, 2005
Last updated: May 14, 2008
Last verified: September 2005
  Purpose

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.


Condition Intervention Phase
Fertility
Pregnancy
Behavioral: Instruction in the Creighton Model Fertility Care System
Behavioral: Preconception advice
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Randomized Trial of Fertility Awareness and Time to Pregnancy in Couples of Normal Fertility

Further study details as provided by University of Utah:

Primary Outcome Measures:
  • Time to Pregnancy [ Time Frame: Up to one year. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Distribution of coitus within "fertile" days of menstrual cycle [ Time Frame: Seven menstrual cycles. ] [ Designated as safety issue: No ]

Enrollment: 143
Study Start Date: January 2003
Study Completion Date: March 2007
Primary Completion Date: August 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Preconception advice.
Behavioral: Preconception advice
Preconception advice for diet and frequency of intercourse.
Experimental: 2
Instruction in the Creighton Model Fertility Care System.
Behavioral: Instruction in the Creighton Model Fertility Care System
Instruction in the Creighton Model Fertility Care System.
Other Name: Fertility awareness instruction.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 35 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00161395

Locations
United States, Utah
University of Utah, Dept. Family and Preventive Medicine
Salt Lake City, Utah, United States, 84108
Sponsors and Collaborators
University of Utah
Investigators
Principal Investigator: Joseph B Stanford, MD University of Utah
  More Information

Additional Information:
No publications provided

Responsible Party: Joseph Stanford, M.D., Principal Investigator, University of Utah
ClinicalTrials.gov Identifier: NCT00161395     History of Changes
Other Study ID Numbers: K23 HD1479
Study First Received: September 8, 2005
Last Updated: May 14, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by University of Utah:
fertility
pregnancy

ClinicalTrials.gov processed this record on November 19, 2014