Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 4:04 PM
Ignite Modification Date:
2025-12-24 @ 4:04 PM
NCT ID:
NCT01509066
Eligibility Criteria:
Inclusion Criteria:
* Women must meet the following criteria:
* have been attempting pregnancy for at least 6 months
* is not currently pregnant
* has a clinical diagnosis of PCOS
* is not on oral medications for insulin resistance (such as metformin) or, if currently on such a medication, has been on the medication at a stable dose for at least 3 months
* willing not use fertility-enhancing medications over the 6-month study (with the exception of oral medications, such as clomiphene citrate, as directed by their physician)
* willing to be randomized to either dietary condition and able to make weekly meetings.
Exclusion Criteria:
Participants should not be in this study if they meet any of the following criteria:
* have not been diagnoses with polycystic ovarian syndrome
* have been trying to conceive less than 6 months
* have a Body Mass Index less than 25 or greater than 45 kg/m2
* are currently pregnant
* are younger than 18 or older than 35 years of age
* are a smoker
* are unable to come to the Columbia, SC area at least 3-4 times in a 6 month time period for assessments
* don't have access to the Internet and a computer
* don't have access to a scale for self-monitoring weight
* aren't willing to be randomized to either group
* have a psychiatric disease, drug or alcohol dependency, or uncontrolled thyroid condition
* have a major health condition, such as heart conditions, diabetes, and past incidence of stroke
* unable to receive consent from your doctor to participate if you currently are on blood pressure medications, have issues with dizziness, or have bone or joint issues
* have an eating disorder
* currently participating in a weight loss program or taking weight loss medications
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
35 Years
Study:
NCT01509066
Study Brief:
Protocol Section:
NCT01509066