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Time to Conceive: A Study of Fertility

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01028365
First Posted: December 9, 2009
Last Update Posted: May 4, 2017
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.
Collaborator:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill
  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 ]
    Examining time-to-pregnancy


Biospecimen Retention:   Samples With DNA
Serum, Urine

Enrollment: 843
Study Start Date: April 2008
Study Completion Date: December 2016
Primary Completion Date: December 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

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.


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
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
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:
Steiner AZ. Biomarkers of ovarian reserve as predictors of reproductive potential. Semin Reprod Med. 2013 Nov;31(6):437-42. doi: 10.1055/s-0033-1356479. Epub 2013 Oct 7. Review.
Evans-Hoeker E, Pritchard DA, Long DL, Herring AH, Stanford JB, Steiner AZ. Cervical mucus monitoring prevalence and associated fecundability in women trying to conceive. Fertil Steril. 2013 Oct;100(4):1033-1038.e1. doi: 10.1016/j.fertnstert.2013.06.002. Epub 2013 Jul 11.
Steiner AZ, Long DL, Herring AH, Kesner JS, Meadows JW, Baird DD. Urinary follicle-stimulating hormone as a measure of natural fertility in a community cohort. Reprod Sci. 2013 May;20(5):549-56. doi: 10.1177/1933719112459226. Epub 2012 Nov 20.
Steiner AZ, Long DL, Tanner C, Herring AH. Effect of vaginal lubricants on natural fertility. Obstet Gynecol. 2012 Jul;120(1):44-51. doi: 10.1097/AOG.0b013e31825b87ae.
Mesen TB, Steiner AZ. Effect of vaginal lubricants on natural fertility. Curr Opin Obstet Gynecol. 2014 Jun;26(3):186-92. doi: 10.1097/GCO.0000000000000066. Review.
Su HI, Flatt SW, Natarajan L, DeMichele A, Steiner AZ. Impact of breast cancer on anti-mullerian hormone levels in young women. Breast Cancer Res Treat. 2013 Jan;137(2):571-7. doi: 10.1007/s10549-012-2361-5. Epub 2012 Dec 9. Erratum in: Breast Cancer Res Treat. 2013 Apr;138(3):975.
Balthazar U, Steiner AZ. Periconceptional changes in thyroid function: a longitudinal study. Reprod Biol Endocrinol. 2012 Mar 21;10:20. doi: 10.1186/1477-7827-10-20.
Baird DD, Steiner AZ. Anti-Müllerian hormone: a potential new tool in epidemiologic studies of female fecundability. Am J Epidemiol. 2012 Feb 15;175(4):245-9. doi: 10.1093/aje/kwr439. Epub 2012 Jan 12.
Steiner AZ, Herring AH, Kesner JS, Meadows JW, Stanczyk FZ, Hoberman S, Baird DD. Antimüllerian hormone as a predictor of natural fecundability in women aged 30-42 years. Obstet Gynecol. 2011 Apr;117(4):798-804. doi: 10.1097/AOG.0b013e3182116bc8.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT01028365     History of Changes
Other Study ID Numbers: 1R21HD060229-01A1 ( U.S. NIH Grant/Contract )
UNC-Chapel Hill ( Other Grant/Funding Number: 5-52208 )
First Submitted: December 7, 2009
First Posted: December 9, 2009
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


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