NCT01028365

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
843

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2008

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2008

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

December 7, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 9, 2009

Completed
7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

May 4, 2017

Status Verified

May 1, 2017

Enrollment Period

8.7 years

First QC Date

December 7, 2009

Last Update Submit

May 3, 2017

Conditions

Healthy

Keywords

FertilityTrying to ConceiveTrying to Get PregnantPregnancy

Outcome Measures

Primary Outcomes (1)

  • Conception

    Examining time-to-pregnancy

    12 months, or until conception

Study Arms (1)

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

Interventions

No interventionOTHER

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.

No treatment

Eligibility Criteria

Age30 Years - 44 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Healthy women living in Chapel Hill, Raleigh, Durham, and the surrounding communities of the Triangle Area in North Carolina.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

Related Publications (12)

  • 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.

    PMID: 23224236BACKGROUND

  • 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.

    PMID: 22436200BACKGROUND

  • Baird DD, Steiner AZ. Anti-Mullerian 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.

    PMID: 22247047BACKGROUND

  • Steiner AZ, Herring AH, Kesner JS, Meadows JW, Stanczyk FZ, Hoberman S, Baird DD. Antimullerian 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.

    PMID: 21422850BACKGROUND

  • 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.

    PMID: 24101224RESULT

  • 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.

    PMID: 23850303RESULT

  • 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.

    PMID: 23171685RESULT

  • 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.

    PMID: 22914390RESULT

  • 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.

    PMID: 24717914RESULT

  • Crawford NM, Pritchard DA, Herring AH, Steiner AZ. Prospective evaluation of luteal phase length and natural fertility. Fertil Steril. 2017 Mar;107(3):749-755. doi: 10.1016/j.fertnstert.2016.11.022. Epub 2017 Jan 5.

    PMID: 28065408DERIVED

  • Steiner AZ, Jukic AM. Impact of female age and nulligravidity on fecundity in an older reproductive age cohort. Fertil Steril. 2016 Jun;105(6):1584-1588.e1. doi: 10.1016/j.fertnstert.2016.02.028. Epub 2016 Mar 5.

    PMID: 26953733DERIVED

  • Crawford NM, Pritchard DA, Herring AH, Steiner AZ. Prospective evaluation of the impact of intermenstrual bleeding on natural fertility. Fertil Steril. 2016 May;105(5):1294-1300. doi: 10.1016/j.fertnstert.2016.01.015. Epub 2016 Jan 25.

    PMID: 26820771DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Serum, Urine

Study Officials

  • Anne Z Steiner, MD, MPH

    University of North Carolina, Chapel Hill

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 7, 2009

First Posted

December 9, 2009

Study Start

April 1, 2008

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

May 4, 2017

Record last verified: 2017-05

Locations

US(1)