Polycystic Ovary SyndromeNCT01859663
Comparison of Lifestyle Markers Between Women With and Without Polycystic Ovary Syndrome
An observational study of Polycystic Ovary Syndrome and Dietary Habits, run by Cornell University at 3 sites in United States.
Trial summary
The purpose of the study is to identify lifestyle factors associated with PCOS and understand how diet and activity levels impact features of PCOS. The secondary aim is to examine psychosocial factors (e.g., health beliefs) of women with PCOS. Read more about this study
- Who is it for?
- Ages 18 to 48 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Polycystic Ovary Syndrome, Dietary Habits, Physical Activity
- How many people
- 126 participants
- Where
- 3 sitesUnited States
- Study dates
- May 2013to May 2022
- 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 to 48 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: New York State. Must be between 18-48 years, with a BMI of 18 kg/m2 or higher.
Who may be able to join
- Between 18 and 48 years
- BMI ≥ 18 kg/m2
- If ≥ 21 years old, must have completed a pelvic exam in the past 2 years
- In PCOS if: Confirmed PCOS diagnosis from their primary care provider
Who cannot join
- Use of oral contraceptives, fertility medications, or any drugs known to influence reproductive function
- Pregnant or breastfeeding
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Human Metabolic Research Unit, Cornell University
Ithaca, New York, 14853
Strong Fertility Center
Rochester, New York, 14623
CRC at University of Rochester Medical Center
Rochester, New York, 14642
About this study
Official title: Baseline Assessment of Dietary Intake and Physical Activity in Women With Polycystic Ovary Syndrome (PCOS)
The purpose of the study is to identify lifestyle factors associated with PCOS and understand how diet and activity levels impact features of PCOS. The secondary aim is to examine psychosocial factors (e.g., health beliefs) of women with PCOS.
Read the detailed description
Polycystic ovary syndrome (PCOS) is an endocrine disorder that affects 6-12% of reproductive-aged women within the general population. Currently, there is limited knowledge on the current lifestyles of women with PCOS and the psychosocial factors associated with PCOS.
The researchers plan to examine potential lifestyle differences and psychosocial factors between PCOS and healthy women. The Research Team is also interested in the relationships between biological markers and lifestyle endpoints in women with and without PCOS. Previous literature has shown there are biological marker differences between those with and without PCOS. By examining these relationships, researchers may further understand whether PCOS status is associated with lifestyle parameters.
To accomplish these objectives, 360 women (120 women with PCOS, 120 women without PCOS and with normal menstrual cycles, and 120 women without PCOS and with irregular menstrual cycles) will be included in this study. An equal number of lean and overweight/obese women will be recruited within each group based on body mass index (BMI; Lean = 18 - 24 kg/m2 and overweight/obese ≥ 25 kg/m2). Women will be included in the PCOS group if they have a confirmed PCOS diagnosis from their primary care provider. Participants will complete a food frequency questionnaire, a sleep questionnaire, and a physical activity questionnaire. A researcher may also provide participants with a waist-worn accelerometer to monitor physical activity and a wrist-worn accelerometer to monitor sleep for a week. Ultrasound scans of the ovaries will be assessed and the following metabolic parameters will be assessed: (1) 75-gram oral glucose tolerance test; (2) dual X-ray absorptiometry (DXA) scan; (3) vitals and anthropometry assessment to measure waist and hip circumference, height, weight, blood pressure, and heart rate; (4) fasting blood tests to detect androgens (i.e., total testosterone, androstenedione, free androgen index); and (5) an (optional) subcutaneous fat biopsy. Women with and without PCOS will also be asked to complete a questionnaire that will assess the psychosocial factors (e.g., health beliefs). This can be conducted online, in person, or through phone.
- Conditions
- Polycystic Ovary Syndrome, Dietary Habits, Physical Activity
- Keywords
- Polycystic Ovary Syndrome (PCOS), Diet, Exercise, Questionnaires, Health Beliefs
- Medical subject headings
- Polycystic Ovary Syndrome, Feeding Behavior, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Women with a past diagnosis of PCOS | We aim to recruit 120 women with a past diagnosis of PCOS. An equal number of lean and overweight/obese women will be recruited within this group based on body mass index (BMI; Lean = 18 - 24 kg/m2 and overweight/obese ≥ 25 kg/m2). | |
| Women with a history of regular menstrual cycles | We aim to recruit 120 women with a history of regular menstrual cycles. An equal number of lean and overweight/obese women will be recruited within this group based on body mass index (BMI; Lean = 18 - 24 kg/m2 and overweight/obese ≥ 25 kg/m2). | |
| Women with a history of irregular menstrual cycles | We aim to recruit 120 women with a history of irregular menstrual cycles, and no previous diagnosis of PCOS. An equal number of lean and overweight/obese women will be recruited within this group based on body mass index (BMI; Lean = 18 - 24 kg/m2 and overweight/obese ≥ 25 kg/m2). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Differences in diet between women with and without PCOS
A food frequency questionnaire will be administered to assess diet composition for the last three months.
Measured: 1 week
Secondary outcomes (16)
Differences in exercise between women with and without PCOS
An accelerometer will be administered to assess physical activity for 1 week.
Measured: 1 week
Differences in psychosocial factors (e.g., health beliefs) of women with and without PCOS
A questionnaire will be administered to assess psychosocial factors of women with PCOS.
Measured: 1-2 weeks
Differences in sleep patterns between women with and without PCOS
A wrist-worn accelerometer will be administered to assess sleep patterns for 6 consecutive nights.
Measured: 6 consecutive nights
LH-FSH ratio
The ratio of circulating LH to FSH concentrations in the serum will be determined for each participant and compared across groups
Measured: 1 day
Hirsutism Score
Degree of hirsutism as judged by the Ferriman-Gallwey scale will be determined and compared across groups
Degree of hirsutism as judged by the Ferriman-Gallwey scale will be determined and compared across groups
Measured: 1 day
Androgen concentrations
Total testosterone, androstenedione and free androgen index concentrations in serum will be determined and compared across groups.
Measured: 1 day
Menstrual Cycle Length
Average menstrual cycle length as determined by self-reported history will be determined and compared across groups
Measured: 1 day
Body Mass Index
The ratio of weight to height will be determined and compared across groups.
Measured: 1 day
Waist-to-Hip Ratio
The ratio of waist circumference to hip circumference will be determined and compared across groups
Measured: 1 day
Ovarian Volume
The size of each ovary will be determined using ultrasonography for each participant during study participation and compared between groups.
Measured: 1 day
Insulin Sensitivity
Insulin sensitivity will be determined by administration of an oral glucose tolerance test and compared between groups.
Measured: 1 day
Serum progesterone concentration
The serum progesterone concentration will be determined during study participation, assessed in association with luteal dynamics and compared between groups.
Measured: 1 day
Blood pressure
Blood pressure will be determined and compared between groups.
Measured: 1 day
Serum markers of metabolic syndrome
Lipids, glucose and HbA1C concentrations will be determined and compared between groups.
Measured: 1 day
Body fat distribution
Percentage and distribution of fat and lean mass as assessed using DXA technology will be compared between groups.
Measured: 1 day
Subcutaneous fat biopsy (optional)
Subcutaneous fat cells, which represent important sites of reproductive hormone synthesis, will be assessed and compared across groups
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2013 (estimated)
- Study startMay 2013
- Primary completionMay 2022
- Study completionMay 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Polycystic Ovary SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 126 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cornell University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Rochester
- Responsible party
- Sponsor
- Investigators
- Marla E. Lujan, PhD, Principal investigator, Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01859663
- Sponsor's protocol ID
- IRB 1303003665
- Status last verified
- Feb 2024
- First submitted
- 17 May 2013
- Last updated
- 9 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
Publications
Evans AT, Rehani E, Smith B, Hong MD, Lewin Z, Hiroshige K, Spandorfer SD, Hajirasouliha I, Lujan ME, Hoeger KM. Diagnosis of Polycystic Ovary Syndrome With Predictive Modeling of Select Clinical Features. O G Open. 2026 Mar 19;3(2):e161. doi: 10.1097/og9.0000000000000161. eCollection 2026 Apr.
PubMed 41868592Lin AW, Dollahite JS, Sobal J, Lujan ME. Health-related knowledge, beliefs and self-efficacy in women with polycystic ovary syndrome. Hum Reprod. 2018 Jan 1;33(1):91-100. doi: 10.1093/humrep/dex351.
PubMed 29182737
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Baseline Assessment of Dietary Intake and Physical Activity in Women With Polycystic Ovary Syndrome (PCOS)
- ClinicalTrials.gov ID
- NCT01859663
- Acronym / sponsor ID
- IRB 1303003665
- Conditions
- Polycystic Ovary Syndrome, Dietary Habits, Physical Activity
- Keywords
- Polycystic Ovary Syndrome (PCOS), Diet, Exercise, Questionnaires, Health Beliefs
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 126 participants (actual)
- Lead sponsor
- Cornell UniversityUniversity, hospital or other
- Collaborators
- University of Rochester
- Study start
- May 2013
- Primary completion
- May 2022 (actual)
- Study completion
- May 2022 (actual)
- First posted
- 22 May 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to identify lifestyle factors associated with PCOS and understand how diet and activity levels impact features of PCOS. The secondary aim is to examine psychosocial factors (e.g., health beliefs) of women with PCOS.
Detailed description
Polycystic ovary syndrome (PCOS) is an endocrine disorder that affects 6-12% of reproductive-aged women within the general population. Currently, there is limited knowledge on the current lifestyles of women with PCOS and the psychosocial factors associated with PCOS.
The researchers plan to examine potential lifestyle differences and psychosocial factors between PCOS and healthy women. The Research Team is also interested in the relationships between biological markers and lifestyle endpoints in women with and without PCOS. Previous literature has shown there are biological marker differences between those with and without PCOS. By examining these relationships, researchers may further understand whether PCOS status is associated with lifestyle parameters.
To accomplish these objectives, 360 women (120 women with PCOS, 120 women without PCOS and with normal menstrual cycles, and 120 women without PCOS and with irregular menstrual cycles) will be included in this study. An equal number of lean and overweight/obese women will be recruited within each group based on body mass index (BMI; Lean = 18 - 24 kg/m2 and overweight/obese ≥ 25 kg/m2). Women will be included in the PCOS group if they have a confirmed PCOS diagnosis from their primary care provider. Participants will complete a food frequency questionnaire, a sleep questionnaire, and a physical activity questionnaire. A researcher may also provide participants with a waist-worn accelerometer to monitor physical activity and a wrist-worn accelerometer to monitor sleep for a week. Ultrasound scans of the ovaries will be assessed and the following metabolic parameters will be assessed: (1) 75-gram oral glucose tolerance test; (2) dual X-ray absorptiometry (DXA) scan; (3) vitals and anthropometry assessment to measure waist and hip circumference, height, weight, blood pressure, and heart rate; (4) fasting blood tests to detect androgens (i.e., total testosterone, androstenedione, free androgen index); and (5) an (optional) subcutaneous fat biopsy. Women with and without PCOS will also be asked to complete a questionnaire that will assess the psychosocial factors (e.g., health beliefs). This can be conducted online, in person, or through phone.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Women with a past diagnosis of PCOS | – | –We aim to recruit 120 women with a past diagnosis of PCOS. An equal number of lean and overweight/obese women will be recruited within this group based on body mass index (BMI; Lean = 18 - 24 kg/m2 and overweight/obese ≥ 25 kg/m2). |
| Women with a history of regular menstrual cycles | – | –We aim to recruit 120 women with a history of regular menstrual cycles. An equal number of lean and overweight/obese women will be recruited within this group based on body mass index (BMI; Lean = 18 - 24 kg/m2 and overweight/obese ≥ 25 kg/m2). |
| Women with a history of irregular menstrual cycles | – | –We aim to recruit 120 women with a history of irregular menstrual cycles, and no previous diagnosis of PCOS. An equal number of lean and overweight/obese women will be recruited within this group based on body mass index (BMI; Lean = 18 - 24 kg/m2 and overweight/obese ≥ 25 kg/m2). |
Who may qualify
- Ages
- 18 to 48 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- New York State. Must be between 18-48 years, with a BMI of 18 kg/m2 or higher.
Key inclusion criteria (4 listed)
- Between 18 and 48 years
- BMI ≥ 18 kg/m2
- If ≥ 21 years old, must have completed a pelvic exam in the past 2 years
- In PCOS if: Confirmed PCOS diagnosis from their primary care provider
Key exclusion criteria (2 listed)
- Use of oral contraceptives, fertility medications, or any drugs known to influence reproductive function
- Pregnant or breastfeeding
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Differences in diet between women with and without PCOS
Time frame: 1 week
A food frequency questionnaire will be administered to assess diet composition for the last three months.
16 secondary outcomes
Differences in exercise between women with and without PCOS
Time frame: 1 week
Differences in psychosocial factors (e.g., health beliefs) of women with and without PCOS
Time frame: 1-2 weeks
Differences in sleep patterns between women with and without PCOS
Time frame: 6 consecutive nights
LH-FSH ratio
Time frame: 1 day
Hirsutism Score
Time frame: 1 day
Androgen concentrations
Time frame: 1 day
Menstrual Cycle Length
Time frame: 1 day
Body Mass Index
Time frame: 1 day
Waist-to-Hip Ratio
Time frame: 1 day
Ovarian Volume
Time frame: 1 day
Insulin Sensitivity
Time frame: 1 day
Serum progesterone concentration
Time frame: 1 day
Blood pressure
Time frame: 1 day
Serum markers of metabolic syndrome
Time frame: 1 day
Body fat distribution
Time frame: 1 day
Subcutaneous fat biopsy (optional)
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2024.
- Derived from this study: PubMed 41868592Evans AT, Rehani E, Smith B, Hong MD, Lewin Z, Hiroshige K, Spandorfer SD, Hajirasouliha I, Lujan ME, Hoeger KM. Diagnosis of Polycystic Ovary Syndrome With Predictive Modeling of Select Clinical Features. O G Open. 2026 Mar 19;3(2):e161. doi: 10.1097/og9.0000000000000161. eCollection 2026 Apr.
- Derived from this study: PubMed 29182737Lin AW, Dollahite JS, Sobal J, Lujan ME. Health-related knowledge, beliefs and self-efficacy in women with polycystic ovary syndrome. Hum Reprod. 2018 Jan 1;33(1):91-100. doi: 10.1093/humrep/dex351.
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The Value of LC-MS/MS Detection of Androgen Profiles in the Diagnosis of PCOS: A Prospective, Multicenter Real-world Study
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marla E. Lujan, PhD principal investigator
Cornell University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Polycystic Ovary Syndrome and Dietary Habits, run by Cornell University at 3 sites 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 4 inclusion and 2 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 9 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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.
What does the primary outcome measure?
Differences in diet between women with and without PCOS (time frame: 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01859663, which also lists 2 linked publications.
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 9 Feb 2024.