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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

September 8, 2005
May 14, 2008
January 2003
August 2006   (final data collection date for primary outcome measure)
Time to Pregnancy [ Time Frame: Up to one year. ] [ Designated as safety issue: No ]
Time to Pregnancy
Complete list of historical versions of study NCT00161395 on ClinicalTrials.gov Archive Site
Distribution of coitus within "fertile" days of menstrual cycle [ Time Frame: Seven menstrual cycles. ] [ Designated as safety issue: No ]
Distribution of coitus within "fertile" days of menstrual cycle
Not Provided
Not Provided
 
Study of Time to Pregnancy in Normal Fertility
Randomized Trial of Fertility Awareness and Time to Pregnancy in Couples of 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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
  • Fertility
  • Pregnancy
  • Behavioral: Instruction in the Creighton Model Fertility Care System
    Instruction in the Creighton Model Fertility Care System.
    Other Name: Fertility awareness instruction.
  • Behavioral: Preconception advice
    Preconception advice for diet and frequency of intercourse.
  • Active Comparator: 1
    Preconception advice.
    Intervention: Behavioral: Preconception advice
  • Experimental: 2
    Instruction in the Creighton Model Fertility Care System.
    Intervention: Behavioral: Instruction in the Creighton Model Fertility Care System
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
143
March 2007
August 2006   (final data collection date for primary outcome measure)

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
Female
18 Years to 35 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00161395
K23 HD1479
No
Joseph Stanford, M.D., Principal Investigator, University of Utah
University of Utah
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Principal Investigator: Joseph B Stanford, MD University of Utah
University of Utah
September 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP