Time to Conceive: A Study of Fertility
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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 |
- 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: | 750 |
| Study Start Date: | April 2008 |
| Estimated Study Completion Date: | January 2015 |
| Estimated Primary Completion Date: | January 2015 (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.
Other Name: No intervention
|
Eligibility| Ages Eligible for Study: | 30 Years to 44 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
Healthy women living in Chapel Hill, Raleigh, Durham, and the surrounding communities of the Triangle Area in North Carolina.
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| Contact: Anne Z Steiner, MD, MPH | 919-843-8246 | fertility@unc.edu |
| Contact: Ashley M Calingo, MPH | 919-843-8246 | fertility@unc.edu |
| United States, North Carolina | |
| University of North Carolina at Chapel Hill | Recruiting |
| Chapel Hill, North Carolina, United States, 27599 | |
| Contact: Ashley M Calingo, MPH 919-843-8246 acalingo@med.unc.edu | |
| Principal Investigator: Anne Z Steiner, MD, MPH | |
| Principal Investigator: | Anne Z Steiner, MD, MPH | University of North Carolina, Chapel Hill |
More Information
Additional Information:
No publications provided
| Responsible Party: | University of North Carolina, Chapel Hill |
| ClinicalTrials.gov Identifier: | NCT01028365 History of Changes |
| Other Study ID Numbers: | 1R21HD060229-01A1, UNC-Chapel Hill, 1R21HD060229-01A1 |
| Study First Received: | December 7, 2009 |
| Last Updated: | February 14, 2012 |
| 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 |
Additional relevant MeSH terms:
|
Infertility Genital Diseases, Male Genital Diseases, Female |
ClinicalTrials.gov processed this record on May 21, 2013