Time to Conceive: A Study of Fertility

This study is ongoing, but not recruiting participants.
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
ClinicalTrials.gov Identifier:
NCT01028365
First received: December 7, 2009
Last updated: October 1, 2015
Last verified: October 2015
  Purpose
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 Intervention
Healthy
Other: No intervention

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Time to Conceive: A Study of Fertility: Biomarkers of Fertility

Further study details as provided by University of North Carolina, Chapel Hill:

Primary Outcome Measures:
  • Conception [ Time Frame: 12 months, or until conception ] [ Designated as safety issue: No ]
    Examining time-to-pregnancy


Biospecimen Retention:   Samples With DNA
Serum, Urine

Estimated Enrollment: 850
Study Start Date: April 2008
Estimated Study Completion Date: September 2016
Estimated Primary Completion Date: September 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   30 Years to 44 Years
Genders 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
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: NCT01028365

Locations
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
Principal Investigator: Anne Z Steiner, MD, MPH University of North Carolina, Chapel Hill
  More Information

Additional Information:
Publications:

Responsible Party: University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT01028365     History of Changes
Other Study ID Numbers: 1R21HD060229-01A1  UNC-Chapel Hill 
Study First Received: December 7, 2009
Last Updated: October 1, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by University of North Carolina, Chapel Hill:
Fertility
Trying to Conceive
Trying to Get Pregnant
Pregnancy

ClinicalTrials.gov processed this record on February 08, 2016