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Time to Conceive: A Study of Fertility

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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

Tracking Information
First Submitted Date December 7, 2009
First Posted Date December 9, 2009
Last Update Posted Date May 4, 2017
Study Start Date April 2008
Actual Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 4, 2011)
Conception [ Time Frame: 12 months, or until conception ]
Examining time-to-pregnancy
Original Primary Outcome Measures
 (submitted: December 8, 2009)
Assess whether blood and monthly urine hormone levels (follicle stimulating hormone (FSH), inhibin B, and antimullerian hormone (AMH)) can predict fertility in women with no history of infertility. [ Time Frame: Up to 6 months, or until conception occurs ]
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Time to Conceive: A Study of Fertility
Official Title Time to Conceive: A Study of Fertility: Biomarkers of Fertility
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Serum, Urine
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.
Condition Healthy
Intervention 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.
Study Groups/Cohorts 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.
Intervention: Other: No intervention
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: May 3, 2017)
843
Original Estimated Enrollment
 (submitted: December 8, 2009)
500
Actual Study Completion Date December 2016
Actual Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: Female
Ages 30 Years to 44 Years   (Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number 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 )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party University of North Carolina, Chapel Hill
Study Sponsor University of North Carolina, Chapel Hill
Collaborators 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
PRS Account University of North Carolina, Chapel Hill
Verification Date May 2017