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Healthy Eating for Reproductive Health: Greenville


Phase 1
18 Years
35 Years
Open (Enrolling)
Female
Polycystic Ovarian Syndrome, Infertility, Obesity, Overweight

Thank you

Trial Information

Healthy Eating for Reproductive Health: Greenville


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Changes in body weight

Outcome Time Frame:

6 months

Safety Issue:

No

Authority:

United States: Institutional Review Board

Study ID:

Pro00019109

NCT ID:

NCT01716429

Start Date:

October 2012

Completion Date:

Related Keywords:

  • Polycystic Ovarian Syndrome
  • Infertility
  • Obesity
  • Overweight
  • vegetarian
  • vegan
  • low calorie
  • weight Loss
  • infertility
  • PCOS
  • Infertility
  • Obesity
  • Polycystic Ovary Syndrome
  • Overweight

Name

Location

Fertility Center of the Carolinas: Greenville Hospital System Greenville, South Carolina  29605