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CompletedNCT00444288Updated Jul 2, 2017

PCOS Twin Study - Environmental Factors in the Development of Polycystic Ovary Syndrome, Phase 2

An observational study in Polycystic Ovary Syndrome, sponsored by National Institute of Environmental Health Sciences (NIEHS). Completed at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-07-02.

Sponsored by National Institute of Environmental Health Sciences (NIEHS) · Observational

Study type
Observational
Time perspective
Other
Ages
18 Years and older
Sex
Female
01

Study summary

Polycystic Ovary Syndrome, or PCOS, is the most common endocrine disorder in women. Depending on the strictness of the diagnostic criteria used, it is thought to occur in about 6-10% of all women, many of whom do not know they have the syndrome. Women with PCOS produce abnormally high levels of male hormones (hyperandrogenism); this counteracts their ovaries' ability to make enough of the female hormones estrogen and progesterone needed for normal menstruation. PCOS is the number one cause of hormonally related infertility and also increases women's risks for diabetes, high blood pressure, hypercholesteremia, cardiovascular disease and certain cancers. It is currently unclear to what extent PCOS and PCOS-associated traits (hyperandrogenisms, hyperinsulinemia, insulin resistance, type 2 diabetes, dyslipidemia, hypertension, obesity, and coronary artery disease) are the results of environmental factors or genetic predisposition. Therefore, the NIEHS Program in Clinical Research is conducting a multi-phase twin study to measure the extent of PCOS heritability and to identify environmental and genetic factors involved in the development of PCOS. The proposal described here is for Phase 2 of this study. The goals of Phase 2 are to: 1) establish more reliable concordance rates and baseline heritability estimates for PCOS in MZ and DZ twins; and 2) establish a cohort of intact MZ and DZ female twin pairs as a resource for future studies.

In Phase 1, about 1500 individual female twins were identified from the Mid-Atlantic Twin Registry (MATR) based on self report of a history of irregular periods and/or cystic ovaries in the MATR General Health Screening Questionnaire. Those twins were surveyed by phone for other traits associated with PCOS. In Phase 2, the twins most likely to have PCOS based on their answers to the Phase 1 phone survey will be recontacted for further PCOS screening. This includes providing a blood sample for measuring bioavailable testosterone (BaT) levels. Women with elevated BaT levels are likely to have PCOS. The women with elevated levels will then be asked to undergo a medical evaluation for PCOS confirmation. This includes a physical exam, medical history, ultrasound, 2-hour glucose tolerance and other biochemical blood tests, and a Ferriman-Gallwey evaluation for abnormal hirsutism (another characteristic of PCOS). The women will also be tested for pregnancy and zygosity. Their female co-twins will be invited to undergo...

Read the detailed description

Polycystic Ovary Syndrome, or PCOS, is the most common endocrine disorder in women. Depending on the strictness of the diagnostic criteria used, it is thought to occur in about 6-10% of all women, many of whom do not know they have the syndrome. Women with PCOS produce abnormally high levels of male hormones (hyperandrogenism); this counteracts their ovaries' ability to make enough of the female hormones estrogen and progesterone needed for normal menstruation. PCOS is the number one cause of hormonally related infertility and also increases women's risks for diabetes, high blood pressure, hypercholesteremia, cardiovascular disease and certain cancers. It is currently unclear to what extent PCOS and PCOS-associated traits (hyperandrogenism, hyperinsulinemia, insulin resistance, type 2 diabetes, dyslipidemia, hypertension, obesity, and coronary artery disease) are the results of environmental factors or genetic predisposition. Therefore, the NIEHS Program in Clinical Research is conducting a multi-phase twin study to measure the extent of PCOS heritability and to identify environmental and genetic factors involved in the development of PCOS. The proposal described here is for Phase 2 of this study. The goals of Phase 2 are to: 1) establish more reliable concordance rates and baseline heritability estimates for PCOS in MZ and DZ twins; and 2) establish a cohort of intact MZ and DZ female twin pairs with PCOS as a resource for future studies.

In Phase 1, about 1500 individual female twins were identified from the Mid-Atlantic Twin Registry (MATR) based on self report of a history of irregular periods and/or cystic ovaries in the MATR General Health Screening Questionnaire. Those twins were surveyed by phone for other traits associated with PCOS. In Phase 2, the twins most likely to have PCOS based on their answers to the Phase 1 phone survey will be recontacted for further PCOS screening. One or both twins in a pair will be screened for elevated levels of testosterone (total and free testosterone, bioavailable testosterone or BaT; free androgen index or FAI). Hyperandrogenism is one of the hallmark traits of PCOS and can be exhibited either biochemically (elevated testosterone) or clinically (hirsutism, acne, hair loss, alopecia, other). If one twin in a pair has an elevated BaT level, then both twins in the pair will be asked to undergo a medical evaluation for PCOS confirmation. This includes a physical exam, medical history, ultrasound, 2-hour glucose tolerance and other biochemical blood tests, and a Ferriman-Gallwey evaluation for abnormal hirsutism (another characteristic of PCOS). The women will also be tested for pregnancy and zygosity. Their female co-twins will be invited to undergo a similar medical evaluation.

Depending on their PCOS traits, twin pairs in which neither member has elevated testosterone levels might be asked to undergo the medical evaluation as well. In clinical practice, PCOS diagnoses are often made on women with normal testosterone levels if they have other certain PCOS traits. The determination to include pairs in which both members have normal testosterone levels will be made depending on their collective PCOS traits that they reported on their Phase 1 survey.

02

Conditions studied

  • Polycystic Ovary Syndrome

Keywords

  • Cystic Ovaries
  • Hyperandrogenism
  • Anovulation
  • Concordance Rates
  • Baseline Heritability
  • Polycystic Ovary Syndrome
  • POS
03

In context

Polycystic Ovary Syndrome

944 studies on the registry are indexed under Polycystic Ovary Syndrome; 174 are open to participants now.

Browse Polycystic Ovary Syndrome studies →

Lead sponsor

National Institute of Environmental Health Sciences (NIEHS) is the lead sponsor of 175 studies on the registry; 18 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

To be included in this study, primary twins must:

  1. Be a premenopausal female twin over the age 18 (this will be asked during recruitment).
  2. Have a living female co-twin (this will be asked during recruitment).
  3. Have a history of probable PCOS defined by having one or more of the following criteria as self-reported in the Phase 1 PCOS survey. These traits will be confirmed during medical evaluation:

    1. History of chronically irregular menstrual cycles
    2. History of hirsutism
    3. History of hair loss
    4. Cysts in ovaries
    5. Body-mass index greater than 25
    6. Acne
  4. Be able and willing to give informed consent.
  5. Agree to undergo a medical evaluation for PCOS.

To be included in this study, co-twins must:

  1. Be a premenopausal female twin over the age of 18 (this will be asked during recruitment).
  2. Be able and willing to give informed consent.
  3. Agree to undergo a medical evaluation for PCOS.

Exclusion criteria

EXCLUSION CRITERIA:

Women will be excluded from the study if they are pregnant or have given birth within the past six months.

Women will also be excluded if they are currently menopausal or past menopause.

Women with any condition that, in the opinion of the investigators, could affect the validity of the study results will be excluded from participating.

Subjects will not be excluded based on race, ethnicity or religion.

05

Study design

Time perspective
Other
06

Study locations

1 site
  • Duke University Medical Center
    Durham, North Carolina 27710, United States
07

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 2, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
08

Registry details

Key details

Study ID
NCT00444288
Lead sponsor
National Institute of Environmental Health Sciences (NIEHS)
First posted
Mar 7, 2007
Start date
Feb 27, 2007
Completion
Mar 1, 2010
Last update
Jul 2, 2017
View the source record on ClinicalTrials.gov ↗

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