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Polycystic Ovary SyndromeNCT00444288

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

An observational study of Polycystic Ovary Syndrome, run by National Institute of Environmental Health Sciences (NIEHS) at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Polycystic Ovary Syndrome
How many people
Not given
Where
1 siteUnited States
Study dates
27 Feb 2007to 1 Mar 2010
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • To be included in this study, primary twins must:
  • Be a premenopausal female twin over the age 18 (this will be asked during recruitment).
  • Have a living female co-twin (this will be asked during recruitment).
  • 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:
  • History of chronically irregular menstrual cycles
  • History of hirsutism
Show all 16Show fewer
  • History of hair loss
  • Cysts in ovaries
  • Body-mass index greater than 25
  • Acne
  • Be able and willing to give informed consent.
  • Agree to undergo a medical evaluation for PCOS.
  • To be included in this study, co-twins must:
  • Be a premenopausal female twin over the age of 18 (this will be asked during recruitment).
  • Be able and willing to give informed consent.
  • Agree to undergo a medical evaluation for PCOS.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Duke University Medical Center

    Durham, North Carolina, 27710

Other trials in United States

About this study

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.

Keywords
Cystic Ovaries, Hyperandrogenism, Anovulation, Concordance Rates, Baseline Heritability, Polycystic Ovary Syndrome, POS
Medical subject headings
Polycystic Ovary Syndrome, Ovarian Cysts, Hyperandrogenism, Anovulation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Mar 2007 (estimated)
  2. Study start27 Feb 2007
  3. Study completion1 Mar 2010

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Time perspective
Other
IDs, dates and publications
ClinicalTrials.gov ID
NCT00444288
Sponsor's protocol ID
999907112
Other IDs
07-E-N112
Status last verified
1 Mar 2010
First submitted
6 Mar 2007
Last updated
2 Jul 2017
Results posted
No

Questions about this trial

What is this clinical trial studying?

An observational study of Polycystic Ovary Syndrome, run by National Institute of Environmental Health Sciences (NIEHS) at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 16 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2017.

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