Menstrual Cycle AbnormalNCT03306849
Ultrasonographic Evaluation of Anovulatory Disorders in Lean and Overweight Women
An observational study of Menstrual Cycle Abnormal and PCOS, run by Cornell University at 1 site in United States.
Trial summary
The investigators would like to determine whether ultrasound features of the ovaries can be used to reliably diagnose different types of anovulatory disorders in women across all body types. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Menstrual Cycle Abnormal, PCOS, Overweight
- How many people
- 59 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2015to Apr 2023
- 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 45 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Women must be able to transport to Weill Cornell University. Eligible participants are between 18-45 years with a BMI of 18.5 kg/m2 or higher. Women are screened and enrolled following consent based on their response to our advertisements. Women are recruited from the general population. Enrollment is restricted to the geographical area.
Who may be able to join
- Aged 18-45 years
- At least 2y post-menarche
- BMI >18.5kg/m2
- Good visibility of the ovaries on ultrasound
- Either:
- Regular menstrual cycles (21-35 days);
- Irregular menstrual cycles (>35 days); or
- Previous diagnosis of PCOS from a primary care provider
Who cannot join
- Weight >300lbs
- Currently pregnant or breast feeding
- History of ovarian surgery
- Use of medications or supplements known or suspected to interfere with reproductive function and/or glucose and lipid metabolism in the past 3 months
- Evidence of reproductive aging as assessed by the principal criteria of STRAW+10 stages
Trial locations and contacts
1 site in 1 country.
United States1 site
Clinical and Translational Science Center
New York, New York, 10065
About this study
The investigators would like to determine whether ultrasound features of the ovaries can be used to reliably diagnose different types of anovulatory disorders in women across all body types. The study will also try to establish whether ultrasound features of the ovary can reflect the degree of reproductive and metabolic problems that a woman with irregular or absent periods might be experiencing.
Read the detailed description
This study is being conducted in order to determine if ultrasound features of the ovaries can be used to reliably diagnose different types of anovulatory disorders in women across all body types. The study will also try to establish whether ultrasound features of the ovary can reflect the degree of reproductive and metabolic problems that a woman with irregular or absent periods might be experiencing. In this way, the researchers can help to maximize the information that can be received when using ultrasound to evaluate patients with concerns over irregular menstrual cycles and/or infertility.
The ovaries are the site of egg production and normally release one egg every month. The process of releasing an egg is called ovulation. The act of releasing an egg is the body's way of ensuring a woman's fertility each month during her reproductive years. There are a number of reasons why ovulation may not occur regularly in women. Some of these reasons are believed to relate to male hormone production (i.e. androgens), body composition, nutrition and overall metabolic health. However, the precise ways in which these factors affect ovulation are unknown.
The researchers plan to evaluate how the ovaries look and function in a large group of women. Their goal is to recruit both lean and overweight women to this study and include both women that have regular, predictable menstrual cycles as well as those that have infrequent or absent menstrual cycles. The researchers will include women with irregular cycles due to increased androgen production, or hyperandrogenic anovulation - as well as those that have irregular cycles but normal androgen levels or normoandrogenic anovulation. The researchers will use ultrasound to collect information on how the ovaries look and function, and then relate the features of the ovaries to body composition, reproductive and metabolic hormones as well as nutritional factors. Because features of the ovaries are expected to be different in lean and overweight women, the researchers hope to develop ultrasound criteria that will help healthcare providers to diagnosis specific ovulation problems in women across all body sizes. Together, this research will help to better understand the complex relationship between nutrition, metabolism and reproductive health in women.
To accomplish these objectives, the investigators plan to recruit 50 women with regular menstrual cycles, 50 women with normoandrogenic anovulation, and 50 women with hyperandrogenic anovulation. Their goal is to recruit an equal number of women in each group who are lean (BMI; Normal weight = 18.5 - 24.9 kg/m2) and overweight or obese (BMI; Overweight = 25 - 29.9 kg/m2; Obese >= 30kg/m2). Ultrasound scans of the ovaries will be assessed for the total number, size, and distribution of follicles using both two- and three-dimensional imaging techniques. Participants will have blood samples collected determine serum concentrations of luteinizing hormone (LH), follicle stimulating hormone (FSH), estradiol, progesterone. The following metabolic parameters will be assessed: (1) 75-gram oral glucose tolerance test to characterize glucose and insulin dynamics at 0, 30, 60, 90, and 120 minutes post-glucose ingestion; (2) dual X-ray absorptiometry (DXA) scan to quantify body fat and lean muscle distribution; (3) vitals and anthropometry assessment to measure waist and hip circumference, height, weight, blood pressure, and heart rate, and (4) fasting blood tests to detect serum concentrations of androgens (i.e., total testosterone, androstenedione, free androgen index) and serum markers of metabolic syndrome (i.e., lipids and hemoglobin A1C). Participants will complete a food frequency questionnaire and physical activity questionnaire. A researcher may also provide participants with an accelerometer to wear for a week.
- Conditions
- Menstrual Cycle Abnormal, PCOS, Overweight, Obesity
- Medical subject headings
- Overweight, Obesity
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 |
|---|---|---|
| Regular menstrual cycles | Women will be assigned to this category if they report a history of regular menstrual cycles (every 21 to 35 days). Recruitment will be targeted such that equal numbers of lean (BMI <25kg/m2) and overweight or obese (BMI >24.9kg/m2) participate. | |
| Normoandrogenic anovulation | Women will be assigned to this category if they do not have clinical or biochemical androgen excess and report a history of irregular menstrual cycles (<21 days or >35 days), including women with a pre-existing diagnosis of PCOS. Recruitment will be targeted such that equal numbers of lean (BMI <25kg/m2) and overweight or obese (BMI >24.9kg/m2) participate. | |
| Hyperandrogenic anovulation | Women will be assigned to this category if they have clinical or biochemical androgen excess and report a history of irregular menstrual cycles (<21 days or >35 days), including women with a pre-existing diagnosis of PCOS. Recruitment will be targeted such that equal numbers of lean (BMI <25kg/m2) and overweight or obese (BMI >24.9kg/m2) participate. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Follicle number per ovary
The number and size of all follicles in each ovary will be assessed by ultrasonography
Measured: 1 day
Secondary outcomes (16)
Follicle number per cross section
The number all follicles in a single cross sectional plane of each ovary will be assessed by ultrasonography
Measured: 1 day
Ovarian volume
The size of each ovary will be determined by ultrasonography for each participant and compared across groups.
Measured: 1 day
Stromal echogenicity on ultrasound
The brightness of the ovarian stroma in a single cross section will be determined by ultrasonography for each participant and compared across groups.
Measured: 1 day
Ovarian area-stromal area ratio
The ratio of the stromal area to the total ovarian area of the ovary in a single cross section will be determined by ultrasonography for each participant and compared across groups.
Measured: 1 day
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
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
Serum markers of metabolic syndrome
Lipids, glucose and HbA1C concentrations will be determined and compared across groups.
Measured: 1 day
Blood Pressure
Blood pressure will be determined and compared across groups. [Time Frame: 1 day]
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
Body fat distribution
Percentage and distribution of fat and lean mass as assessed using DXA technology will be compared across groups.
Measured: 1 day
Insulin sensitivity
Insulin sensitivity will be determined by administration of an oral glucose tolerance test and compared across groups.
Measured: 1 day
Differences in diet composition assessed via food frequency questionnaire
A food frequency questionnaire will be administered to assess diet composition for the last three months and will be compared across groups
Measured: 1 day
Differences in energy expenditure assessed via a waist-worn accelerometer
Participants will be asked to wear a small accelerometer device to assess physical activity
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2017
- Study startAug 2015
- Primary completionApr 2023
- Study completionApr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Menstrual Cycle AbnormalStudies 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
- Cross-sectional
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cornell University
- Sponsor type
- University, hospital or other
- Collaborators
- Weill Medical College of Cornell University
- Responsible party
- Sponsor
- Investigators
- Marla E Lujan, PhD, Principal investigator, Cornell UniversitySteven Spandorfer, MD, Principal investigator, Weill Medical College of Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03306849
- Sponsor's protocol ID
- 1410015577
- Status last verified
- Feb 2024
- First submitted
- 6 Oct 2017
- Last updated
- 9 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- 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 41868592
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
- Ultrasonographic Evaluation of Anovulatory Disorders in Lean and Overweight Women
- ClinicalTrials.gov ID
- NCT03306849
- Acronym / sponsor ID
- 1410015577
- Conditions
- Menstrual Cycle Abnormal, PCOS, Overweight, Obesity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Cornell UniversityUniversity, hospital or other
- Collaborators
- Weill Medical College of Cornell University
- Study start
- Aug 2015 (actual)
- Primary completion
- Apr 2023 (actual)
- Study completion
- Apr 2023 (actual)
- First posted
- 11 Oct 2017 (actual)
- 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 investigators would like to determine whether ultrasound features of the ovaries can be used to reliably diagnose different types of anovulatory disorders in women across all body types. The study will also try to establish whether ultrasound features of the ovary can reflect the degree of reproductive and metabolic problems that a woman with irregular or absent periods might be experiencing.
Detailed description
This study is being conducted in order to determine if ultrasound features of the ovaries can be used to reliably diagnose different types of anovulatory disorders in women across all body types. The study will also try to establish whether ultrasound features of the ovary can reflect the degree of reproductive and metabolic problems that a woman with irregular or absent periods might be experiencing. In this way, the researchers can help to maximize the information that can be received when using ultrasound to evaluate patients with concerns over irregular menstrual cycles and/or infertility.
The ovaries are the site of egg production and normally release one egg every month. The process of releasing an egg is called ovulation. The act of releasing an egg is the body's way of ensuring a woman's fertility each month during her reproductive years. There are a number of reasons why ovulation may not occur regularly in women. Some of these reasons are believed to relate to male hormone production (i.e. androgens), body composition, nutrition and overall metabolic health. However, the precise ways in which these factors affect ovulation are unknown.
The researchers plan to evaluate how the ovaries look and function in a large group of women. Their goal is to recruit both lean and overweight women to this study and include both women that have regular, predictable menstrual cycles as well as those that have infrequent or absent menstrual cycles. The researchers will include women with irregular cycles due to increased androgen production, or hyperandrogenic anovulation - as well as those that have irregular cycles but normal androgen levels or normoandrogenic anovulation. The researchers will use ultrasound to collect information on how the ovaries look and function, and then relate the features of the ovaries to body composition, reproductive and metabolic hormones as well as nutritional factors. Because features of the ovaries are expected to be different in lean and overweight women, the researchers hope to develop ultrasound criteria that will help healthcare providers to diagnosis specific ovulation problems in women across all body sizes. Together, this research will help to better understand the complex relationship between nutrition, metabolism and reproductive health in women.
To accomplish these objectives, the investigators plan to recruit 50 women with regular menstrual cycles, 50 women with normoandrogenic anovulation, and 50 women with hyperandrogenic anovulation. Their goal is to recruit an equal number of women in each group who are lean (BMI; Normal weight = 18.5 - 24.9 kg/m2) and overweight or obese (BMI; Overweight = 25 - 29.9 kg/m2; Obese >= 30kg/m2). Ultrasound scans of the ovaries will be assessed for the total number, size, and distribution of follicles using both two- and three-dimensional imaging techniques. Participants will have blood samples collected determine serum concentrations of luteinizing hormone (LH), follicle stimulating hormone (FSH), estradiol, progesterone. The following metabolic parameters will be assessed: (1) 75-gram oral glucose tolerance test to characterize glucose and insulin dynamics at 0, 30, 60, 90, and 120 minutes post-glucose ingestion; (2) dual X-ray absorptiometry (DXA) scan to quantify body fat and lean muscle distribution; (3) vitals and anthropometry assessment to measure waist and hip circumference, height, weight, blood pressure, and heart rate, and (4) fasting blood tests to detect serum concentrations of androgens (i.e., total testosterone, androstenedione, free androgen index) and serum markers of metabolic syndrome (i.e., lipids and hemoglobin A1C). Participants will complete a food frequency questionnaire and physical activity questionnaire. A researcher may also provide participants with an accelerometer to wear for a week.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Regular menstrual cycles | – | –Women will be assigned to this category if they report a history of regular menstrual cycles (every 21 to 35 days). Recruitment will be targeted such that equal numbers of lean (BMI <25kg/m2) and overweight or obese (BMI >24.9kg/m2) participate. |
| Normoandrogenic anovulation | – | –Women will be assigned to this category if they do not have clinical or biochemical androgen excess and report a history of irregular menstrual cycles (<21 days or >35 days), including women with a pre-existing diagnosis of PCOS. Recruitment will be targeted such that equal numbers of lean (BMI <25kg/m2) and overweight or obese (BMI >24.9kg/m2) participate. |
| Hyperandrogenic anovulation | – | –Women will be assigned to this category if they have clinical or biochemical androgen excess and report a history of irregular menstrual cycles (<21 days or >35 days), including women with a pre-existing diagnosis of PCOS. Recruitment will be targeted such that equal numbers of lean (BMI <25kg/m2) and overweight or obese (BMI >24.9kg/m2) participate. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Women must be able to transport to Weill Cornell University. Eligible participants are between 18-45 years with a BMI of 18.5 kg/m2 or higher. Women are screened and enrolled following consent based on their response to our advertisements. Women are recruited from the general population. Enrollment is restricted to the geographical area.
Key inclusion criteria (8 listed)
- Aged 18-45 years
- At least 2y post-menarche
- BMI >18.5kg/m2
- Good visibility of the ovaries on ultrasound
- Regular menstrual cycles (21-35 days);
Key exclusion criteria (5 listed)
- Weight >300lbs
- Currently pregnant or breast feeding
- History of ovarian surgery
- Use of medications or supplements known or suspected to interfere with reproductive function and/or glucose and lipid metabolism in the past 3 months
- Evidence of reproductive aging as assessed by the principal criteria of STRAW+10 stages
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
Follicle number per ovary
Time frame: 1 day
The number and size of all follicles in each ovary will be assessed by ultrasonography
16 secondary outcomes
Follicle number per cross section
Time frame: 1 day
Ovarian volume
Time frame: 1 day
Stromal echogenicity on ultrasound
Time frame: 1 day
Ovarian area-stromal area ratio
Time frame: 1 day
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
Serum markers of metabolic syndrome
Time frame: 1 day
Blood Pressure
Time frame: 1 day
Body mass index
Time frame: 1 day
Waist-to-hip ratio
Time frame: 1 day
Body fat distribution
Time frame: 1 day
Insulin sensitivity
Time frame: 1 day
Differences in diet composition assessed via food frequency questionnaire
Time frame: 1 day
Differences in energy expenditure assessed via a waist-worn accelerometer
Time frame: 1 week
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.
Related trials for Menstrual Cycle Abnormal
RecruitingObservational study
Association of Ultrasound Features of the Myometrium Suggestive of Adenomyosis and Clinical Symptoms
Adenomyosis of Uterus
RecruitingObservational study
Menstrual Cycle Symptoms and Female Health
Menstrual Cycle, Menstrual Distress (Dysmenorrhea)
RecruitingPhase 2/3
Autologous Platelet Rich Plasma (PRP) Intra Ovarian Infusion in Perimenopausal Women
Infertility, Female, Perimenopausal Disorder
Recruiting
The Impact of Whole-Body Vibration and Relaxation Techniques on Adolescent Athlete Girls With Triad Syndrome"
Menstrual Cycle Abnormal
Not yet recruitingObservational study
Measurement of Urinary Hormones in Patients With Abnormal Uterine Bleeding to Study Uterine Cancer Progression
Uterine Bleeding, Uterine Cancer
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
Steven Spandorfer, MD principal investigator
Weill Medical College of Cornell University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Menstrual Cycle Abnormal and PCOS, run by Cornell University 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 8 inclusion and 5 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 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.
What does the primary outcome measure?
Follicle number per ovary (time frame: 1 day). 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 NCT03306849, which also lists 1 linked publication.
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; AzTrials last refreshed its copy on 8 Nov 2026.