Time to Conceive: A Study of Fertility

NCT ID: NCT01028365

Last Updated: 2017-05-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

843 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-04-30

Study Completion Date

2016-12-31

Brief Summary

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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

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Conditions

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Healthy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

No intervention

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

30 Years

Maximum Eligible Age

44 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

NIH

Sponsor Role collaborator

University of North Carolina, Chapel Hill

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Anne Z Steiner, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

University of North Carolina, Chapel Hill

Locations

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University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 23224236 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22436200 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22247047 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21422850 (View on PubMed)

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.

Reference Type RESULT
PMID: 24101224 (View on PubMed)

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.

Reference Type RESULT
PMID: 23850303 (View on PubMed)

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.

Reference Type RESULT
PMID: 23171685 (View on PubMed)

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.

Reference Type RESULT
PMID: 22914390 (View on PubMed)

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.

Reference Type RESULT
PMID: 24717914 (View on PubMed)

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.

Reference Type DERIVED
PMID: 28065408 (View on PubMed)

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.

Reference Type DERIVED
PMID: 26953733 (View on PubMed)

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.

Reference Type DERIVED
PMID: 26820771 (View on PubMed)

Other Identifiers

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UNC-Chapel Hill

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

1R21HD060229-01A1

Identifier Type: NIH

Identifier Source: secondary_id

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1R21HD060229-01A1

Identifier Type: NIH

Identifier Source: org_study_id

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