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Time to Conceive: A Study of Fertility

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01028365
Recruitment Status : Completed
First Posted : December 9, 2009
Last Update Posted : May 4, 2017
Sponsor:
Collaborator:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill

Study Description
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Brief Summary:
The purpose of this research study is to learn a way to measure a person's fertility. After 1 year of trying, 1 out of every 7 women will not be pregnant. This is called infertility. This results in significant distress and anxiety. Infertility is common; however, the investigators have no markers to predict who will be infertile. For couples diagnosed with infertility, the investigators have used blood and urine hormone levels (follicle stimulating hormone (FSH), inhibin B, and antimullerian hormone (AMH)) to tell us who will get pregnant with fertility treatment. The investigators don't know if these hormone levels can predict if regular people trying to get pregnant will be able to get pregnant. This study will try to determine if these hormone levels can predict fertility and infertility.

Condition or disease Intervention/treatment
Healthy Other: No intervention

Study Design
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Study Type : Observational
Actual Enrollment : 843 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Time to Conceive: A Study of Fertility: Biomarkers of Fertility
Study Start Date : April 2008
Actual Primary Completion Date : December 2016
Actual Study Completion Date : December 2016
Groups and Cohorts
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Group/Cohort Intervention/treatment
No treatment
Study participants will not be asked to make any changes to their daily lifestyle or existing health care routine. Participants also will not be asked to take any medications or change their diet.
 Other: No intervention
Study participants will not be asked to make any changes to their daily lifestyle or existing health care routine. Participants also will not be asked to take any medications or change their diet.


Outcome Measures
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Primary Outcome Measures :
  1. Conception [ Time Frame: 12 months, or until conception ]
    Examining time-to-pregnancy


Biospecimen Retention:   Samples With DNA
Serum, Urine

Eligibility Criteria
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Information from the National Library of Medicine

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, Learn About Clinical Studies.


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Ages Eligible for Study:   30 Years to 44 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Healthy women living in Chapel Hill, Raleigh, Durham, and the surrounding communities of the Triangle Area in North Carolina.
Criteria

Inclusion Criteria:

  • women between the ages of 30 and 44
  • hoping to get pregnant and about to start trying or have been trying for less than 3 months
  • living with male partner

Exclusion Criteria:

  • currently using birth control with no intention of stopping
  • have been trying to get pregnant for more than 3 months
  • have used hormone shots for birth control in the past year
  • have renal failure
  • have known fertility problems, such as polycystic ovarian syndrome (PCOS)
  • plan on moving outside of the Triangle Area in the next 6 months
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01028365


Locations
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United States, North Carolina
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States, 27599
Sponsors and Collaborators
University of North Carolina, Chapel Hill
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators
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Principal Investigator: Anne Z Steiner, MD, MPH University of North Carolina, Chapel Hill
More Information
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Publications of Results:

Other Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT01028365    
Other Study ID Numbers: 1R21HD060229-01A1 ( U.S. NIH Grant/Contract )
UNC-Chapel Hill ( Other Grant/Funding Number: 5-52208 )
1R21HD060229-01A1 ( U.S. NIH Grant/Contract )
First Posted: December 9, 2009    Key Record Dates
Last Update Posted: May 4, 2017
Last Verified: May 2017
Keywords provided by University of North Carolina, Chapel Hill:
Fertility
Trying to Conceive
Trying to Get Pregnant
Pregnancy