Ultrasonographic Evaluation of Anovulatory Disorders in Lean and Overweight Women

NCT ID: NCT03306849

Last Updated: 2024-02-09

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 59 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-08-31
• Study Completion Date: 2023-04-30

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.

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

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

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.

No interventions assigned to this group

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.

No interventions assigned to this group

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.

No interventions assigned to this group

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Weill Medical College of Cornell University

OTHER

Sponsor Role: collaborator

Cornell University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Marla E Lujan, PhD

Role: PRINCIPAL_INVESTIGATOR

Cornell University

Steven Spandorfer, MD

Role: PRINCIPAL_INVESTIGATOR

Weill Medical College of Cornell University

Locations

Clinical and Translational Science Center

New York, New York, United States

Countries

United States

Other Identifiers

1410015577

Identifier Type: -

Identifier Source: org_study_id