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Ultrasonographic Evaluation of Anovulatory Disorders in Lean and Overweight Women

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ClinicalTrials.gov Identifier: NCT03306849
Recruitment Status : Suspended (Suspended due to COVID-19; no suspension of IRB approval.)
First Posted : October 11, 2017
Last Update Posted : April 17, 2020
Sponsor:
Collaborator:
Weill Medical College of Cornell University
Information provided by (Responsible Party):
Cornell University

Brief 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. 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.

Condition or disease
Menstrual Cycle Abnormal PCOS Overweight Obesity

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.

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Study Type : Observational
Estimated Enrollment : 150 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: Ultrasonographic Evaluation of Anovulatory Disorders in Lean and Overweight Women
Actual Study Start Date : August 2015
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Group/Cohort
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.



Primary Outcome Measures :
  1. Follicle number per ovary [ Time Frame: 1 day ]
    The number and size of all follicles in each ovary will be assessed by ultrasonography


Secondary Outcome Measures :
  1. Follicle number per cross section [ Time Frame: 1 day ]
    The number all follicles in a single cross sectional plane of each ovary will be assessed by ultrasonography

  2. Ovarian volume [ Time Frame: 1 day ]
    The size of each ovary will be determined by ultrasonography for each participant and compared across groups.

  3. Stromal echogenicity on ultrasound [ Time Frame: 1 day ]
    The brightness of the ovarian stroma in a single cross section will be determined by ultrasonography for each participant and compared across groups.

  4. Ovarian area-stromal area ratio [ Time Frame: 1 day ]
    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.

  5. LH-FSH ratio [ Time Frame: 1 day ]
    The ratio of circulating LH to FSH concentrations in the serum will be determined for each participant and compared across groups

  6. Hirsutism Score [ Time Frame: 1 day ]
    Degree of hirsutism as judged by the Ferriman-Gallwey scale will be determined and compared across groups

  7. Androgen concentrations [ Time Frame: 1 day ]
    Total testosterone, androstenedione and free androgen index concentrations in serum will be determined and compared across groups.

  8. Menstrual Cycle Length [ Time Frame: 1 day ]
    Average menstrual cycle length as determined by self-reported history will be determined and compared across groups

  9. Serum markers of metabolic syndrome [ Time Frame: 1 day ]
    Lipids, glucose and HbA1C concentrations will be determined and compared across groups.

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

  11. Body mass index [ Time Frame: 1 day ]
    The ratio of weight to height will be determined and compared across groups.

  12. Waist-to-hip ratio [ Time Frame: 1 day ]
    The ratio of waist circumference to hip circumference will be determined and compared across groups

  13. Body fat distribution [ Time Frame: 1 day ]
    Percentage and distribution of fat and lean mass as assessed using DXA technology will be compared across groups.

  14. Insulin sensitivity [ Time Frame: 1 day ]
    Insulin sensitivity will be determined by administration of an oral glucose tolerance test and compared across groups.

  15. Differences in diet composition assessed via food frequency questionnaire [ Time Frame: 1 day ]
    A food frequency questionnaire will be administered to assess diet composition for the last three months and will be compared across groups

  16. Differences in energy expenditure assessed via a waist-worn accelerometer [ Time Frame: 1 week ]
    Participants will be asked to wear a small accelerometer device to assess physical activity


Biospecimen Retention:   None Retained
26mL Blood


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
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.
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03306849


Locations
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United States, New York
Clinical and Translational Science Center
New York, New York, United States, 10065
Sponsors and Collaborators
Cornell University
Weill Medical College of Cornell University
Investigators
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Principal Investigator: Marla E Lujan, PhD Cornell University
Principal Investigator: Steven Spandorfer, MD Weill Medical College of Cornell University
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Responsible Party: Cornell University
ClinicalTrials.gov Identifier: NCT03306849    
Other Study ID Numbers: 1410015577
First Posted: October 11, 2017    Key Record Dates
Last Update Posted: April 17, 2020
Last Verified: April 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Overweight
Body Weight
Signs and Symptoms