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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.

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

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

Other trials in United States

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.

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 groups in NCT03306849
Study groupRoleWhat they receive
Regular menstrual cyclesWomen 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 anovulationWomen 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 anovulationWomen 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.

  1. 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)
  1. 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

  2. Ovarian volume

    The size of each ovary will be determined by ultrasonography for each participant and compared across groups.

    Measured: 1 day

  3. 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

  4. 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

  5. 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

  6. Hirsutism Score

    Degree of hirsutism as judged by the Ferriman-Gallwey scale will be determined and compared across groups

    Measured: 1 day

  7. Androgen concentrations

    Total testosterone, androstenedione and free androgen index concentrations in serum will be determined and compared across groups.

    Measured: 1 day

  8. Menstrual Cycle Length

    Average menstrual cycle length as determined by self-reported history will be determined and compared across groups

    Measured: 1 day

  9. Serum markers of metabolic syndrome

    Lipids, glucose and HbA1C concentrations will be determined and compared across groups.

    Measured: 1 day

  10. Blood Pressure

    Blood pressure will be determined and compared across groups. [Time Frame: 1 day]

    Measured: 1 day

  11. Body mass index

    The ratio of weight to height will be determined and compared across groups.

    Measured: 1 day

  12. Waist-to-hip ratio

    The ratio of waist circumference to hip circumference will be determined and compared across groups

    Measured: 1 day

  13. Body fat distribution

    Percentage and distribution of fat and lean mass as assessed using DXA technology will be compared across groups.

    Measured: 1 day

  14. Insulin sensitivity

    Insulin sensitivity will be determined by administration of an oral glucose tolerance test and compared across groups.

    Measured: 1 day

  15. 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

  16. 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.

  1. First posted11 Oct 2017
  2. Study startAug 2015
  3. Primary completionApr 2023
  4. Study completionApr 2023

Resources

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)
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

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.

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