Expired Study
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Salt Lake City, Utah 84108


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.


Study summary:

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.


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


Study is Available At:


Original ID:

K23 HD1479


NCT ID:

NCT00161395


Secondary ID:


Study Acronym:


Brief Title:

Study of Time to Pregnancy in Normal Fertility


Official Title:

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


Overall Status:

Completed


Study Phase:

Phase 2


Genders:

Female


Minimum Age:

18 Years


Maximum Age:

35 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

University of Utah


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification:


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

143


Enrollment Type:

Actual


Overall Contact Information

Official Name:Joseph B Stanford, MD
Principal Investigator
University of Utah

Study Dates

Start Date:January 2003
Completion Date:March 2007
Completion Type:Actual
Primary Completion Date:August 2006
Primary Completion Type:Actual
Verification Date:September 2005
Last Changed Date:May 14, 2008
First Received Date:September 8, 2005

Study Outcomes

Outcome Type:Primary Outcome
Measure:Time to Pregnancy
Time Frame:Up to one year.
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Distribution of coitus within "fertile" days of menstrual cycle
Time Frame:Seven menstrual cycles.
Safety Issues:False

Study Interventions

Intervention Type:Behavioral
Name:Instruction in the Creighton Model Fertility Care
Description:Instruction in the Creighton Model Fertility Care System.
Arm Name:2
Other Name:Fertility awareness instruction.
Intervention Type:Behavioral
Name:Preconception advice
Description:Preconception advice for diet and frequency of intercourse.
Arm Name:1

Study Arms

Study Arm Type:Active Comparator
Arm Name:1
Description:Preconception advice.
Study Arm Type:Experimental
Arm Name:2
Description:Instruction in the Creighton Model Fertility Care System.

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:University of Utah
Agency Class:NIH
Agency Type:Collaborator
Agency Name:Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: November 18, 2019

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