Ignite Creation Date:
2024-05-05 @ 4:55 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00341731
Status:
COMPLETED
Last Update Posted:
2009-12-01
First Post:
2006-06-19
Brief Title:
Environmental Factors in the Development of Polycystic Ovary Syndrome
Sponsor:
National Institute of Environmental Health Sciences NIEHS
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Environmental Factors in the Development of Polycystic Ovary Syndrome
Status:
COMPLETED
Status Verified Date:
2008-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Polycystic Ovary Syndrome PCOS is manifested as a heterogeneous mixture of clinical and bichemical characteristics that complicate study of its etiology It is currently unclear to what extent PCOS-associated traits hyperandrogenism hyperinsulinemia insulin resistance type 2 diabetes dyslipidemia hypertension obesity and coronary artery disease are the result of environmental factors or genetic predisposition We propose to conduct a twin study to investigate the possibility that environmental factors are important in the development of the PCOS phenotype Twin studies are considered to be the gold standard for determining the extent of heritability of a trait The proposal described here is only for Step 1 of a larger multi-step study The major goal of step 1 is to identify a large cohort of twin pairs in which at least one member of each pair is likely to have PCOS
Participants for this study will come from the Mid-Atlantic Twin Registry MATR Many 3283 potential participants have already been identified based on their answers to a preliminary MATR screening questionnaire Out of the approximately 7145 twin women of reproductive age who completed these MATR screening questionnaires 1803 women reported irregular periods 954 reported ovarian cysts and 526 reported both irregular periods and ovarian cysts Many of the women in this last group are likely to have PCOS They represent 74 of the total sample matching current estimates of PCOS prevalence 4-7 in reproductive age women We will also add new twin pairs who meet the criteria irregular periods and evidence of PCOS or cystic ovaries as they are recruited into the MATR and take the preliminary surveys According to MATR statistics about 33 of twin pairs are monozygotic MZ identical Therefore approximately 174 of the 526 women likely to have PCOS are members of a MZ pair
Step 1 of the proposed study consists of a telephone survey of the 3282 women with irregular periods andor ovarian cysts The survey will be conducted by the MATR The instrument to be used contains a series of simple and direct questions and will take about 10 minutes to complete The questions were designed to identify PCOS and their content deals with the frequency of menstrual periods six or fewer per year being a major diagnostic criterion a previous diagnosis of PCOS obesity excess facial hair and other evidence of hyperandrogenism The women will also be asked if t
Participants for this study will come from the Mid-Atlantic Twin Registry MATR Many 3283 potential participants have already been identified based on their answers to a preliminary MATR screening questionnaire Out of the approximately 7145 twin women of reproductive age who completed these MATR screening questionnaires 1803 women reported irregular periods 954 reported ovarian cysts and 526 reported both irregular periods and ovarian cysts Many of the women in this last group are likely to have PCOS They represent 74 of the total sample matching current estimates of PCOS prevalence 4-7 in reproductive age women We will also add new twin pairs who meet the criteria irregular periods and evidence of PCOS or cystic ovaries as they are recruited into the MATR and take the preliminary surveys According to MATR statistics about 33 of twin pairs are monozygotic MZ identical Therefore approximately 174 of the 526 women likely to have PCOS are members of a MZ pair
Step 1 of the proposed study consists of a telephone survey of the 3282 women with irregular periods andor ovarian cysts The survey will be conducted by the MATR The instrument to be used contains a series of simple and direct questions and will take about 10 minutes to complete The questions were designed to identify PCOS and their content deals with the frequency of menstrual periods six or fewer per year being a major diagnostic criterion a previous diagnosis of PCOS obesity excess facial hair and other evidence of hyperandrogenism The women will also be asked if t
Detailed Description:
Polycystic Ovary Syndrome PCOS is manifested as a heterogeneous mixture of clinical and bichemical characteristics that complicate study of its etiology It is currently unclear to what extent PCOS-associated traits hyperandrogenism hyperinsulinemia insulin resistance type 2 diabetes dyslipidemia hypertension obesity and coronary artery disease are the result of environmental factors or genetic predisposition We propose to conduct a twin study to investigate the possibility that environmental factors are important in the development of the PCOS phenotype Twin studies are considered to be the gold standard for determining the extent of heritability of a trait The proposal described here is only for Step 1 of a larger multi-step study The major goal of step 1 is to identify a large cohort of twin pairs in which at least one member of each pair is likely to have PCOS
Participants for this study will come from the Mid-Atlantic Twin Registry MATR Many 3283 potential participants have already been identified based on their answers to a preliminary MATR screening questionnaire Out of the approximately 7145 twin women of reproductive age who completed these MATR screening questionnaires 1803 women reported irregular periods 954 reported ovarian cysts and 526 reported both irregular periods and ovarian cysts Many of the women in this last group are likely to have PCOS They represent 74 of the total sample matching current estimates of PCOS prevalence 4-7 in reproductive age women We will also add new twin pairs who meet the criteria irregular periods and evidence of PCOS or cystic ovaries as they are recruited into the MATR and take the preliminary surveys According to MATR statistics about 33 of twin pairs are monozygotic MZ identical Therefore approximately 174 of the 526 women likely to have PCOS are members of a MZ pair
Step 1 of the proposed study consists of a telephone survey of the 3282 women with irregular periods andor ovarian cysts The survey will be conducted by the MATR The instrument to be used contains a series of simple and direct questions and will take about 10 minutes to complete The questions were designed to identify PCOS and their content deals with the frequency of menstrual periods six or fewer per year being a major diagnostic criterion a previous diagnosis of PCOS obesity excess facial hair and other evidence of hyperandrogenism The women will also be asked if they have a living twin sister On the basis of this survey women will be identified who are likely to have PCOS and have a living female twin
Participants for this study will come from the Mid-Atlantic Twin Registry MATR Many 3283 potential participants have already been identified based on their answers to a preliminary MATR screening questionnaire Out of the approximately 7145 twin women of reproductive age who completed these MATR screening questionnaires 1803 women reported irregular periods 954 reported ovarian cysts and 526 reported both irregular periods and ovarian cysts Many of the women in this last group are likely to have PCOS They represent 74 of the total sample matching current estimates of PCOS prevalence 4-7 in reproductive age women We will also add new twin pairs who meet the criteria irregular periods and evidence of PCOS or cystic ovaries as they are recruited into the MATR and take the preliminary surveys According to MATR statistics about 33 of twin pairs are monozygotic MZ identical Therefore approximately 174 of the 526 women likely to have PCOS are members of a MZ pair
Step 1 of the proposed study consists of a telephone survey of the 3282 women with irregular periods andor ovarian cysts The survey will be conducted by the MATR The instrument to be used contains a series of simple and direct questions and will take about 10 minutes to complete The questions were designed to identify PCOS and their content deals with the frequency of menstrual periods six or fewer per year being a major diagnostic criterion a previous diagnosis of PCOS obesity excess facial hair and other evidence of hyperandrogenism The women will also be asked if they have a living twin sister On the basis of this survey women will be identified who are likely to have PCOS and have a living female twin
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 01-E-N047 | None | None | None |