Ultrasonographic Evaluation of Anovulatory Disorders in Lean and Overweight Women
Condition: Menstrual Cycle Abnormal; PCOS; Overweight; Obesity
MeSH terms: Overweight
Study type: Observational

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.
    

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.
    

Observational model: Case-Control
Time perspective: Cross-Sectional
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.
      
Biospecimen description: 
      26mL Blood