Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03306849 |
| Other study ID # |
1410015577 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
August 2015 |
| Est. completion date |
April 2023 |
Study information
| Verified date |
February 2024 |
| Source |
Cornell University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical 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. 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.
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.
