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Clinical Trials/NCT01028365
NCT01028365CompletedNot Applicable

Time to Conceive: A Study of Fertility: Biomarkers of Fertility

University of North Carolina, Chapel Hill1 site in 1 country843 target enrollmentStarted: April 2008Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
843
Locations
1
Primary Endpoint
Conception

Study Overview

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.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
30 Years to 44 Years (Adult)
Sex
Female
Accepts Healthy Volunteers
Yes

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

Outcomes

Primary Outcomes

Conception

Time Frame: 12 months, or until conception

Examining time-to-pregnancy

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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Time to Conceive: A Study of Fertility | Clinical Trial