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Researchers seek women with Polycystic Ovary Syndrome for genetics study

Research Participant Criteria

To be eligible for this study, you must meet the following criteria:

  • Gender: Female
  • Age: 13 - 45 Years
  • Chronic oligo/anovulation. Eight or fewer periods per year
  • Hyperandrogenism, based on elevated circulating testosterone levels.
Exclusion Criteria

You are not eligible if any of the following applies to you:

  • Current pregnancy.
  • Patients on oral contraceptives, depo progestins, or hormonal implants. A three-month washout period will be required prior to screening for patients on these agents. Longer washouts may be necessary for certain depot contraceptive forms such as Norplant, where the implants are still in place. A one-month washout will be required for patients on oral cyclic progestins.
  • Patients with hyperprolactinemia (defined as two prolactin levels at least one week apart > 30 ng/mL or as determined by local normative values). The goal of eliminating patients with documented hyperprolactinemia is to decrease the heterogeneity of the PCOS population. A normal level within the last year is adequate for entry.
  • Patients with known 21-hydroxylase deficiency or other enzyme deficiency leading to the phenotype of congenital adrenal hyperplasia. 21-hydroxylase deficiency will be excluded in all patients by an ACTH stimulation test. A 1-hour stimulated value > 10 ng/mL will be an exclusion (24).
  • Patients who are menopausal
  • Patients with uncorrected thyroid disease.

Research Study Details

Phenotyping Kindreds of Familial PCOS

The purpose of this study is to better understand disorders of the menstrual cycle related to polycystic ovary syndrome. The study will explore the full range of reproductive and metabolic abnormalities that may be associated with it and to see the extent that family members are affected.

These studies will address how a slight excess of male hormones may decrease the body's sensitivity to the sugar regulating hormone, insulin, and how insulin might cause abnormalities of reproductive function.  Additionally, the study will examine the effect of these male hormones on blood lipids that are related to risk for heart disease.  Approximately 2000 individuals will be studied.

You will be asked to fast for 10 hours prior to your visit at the Hershey Medical Center and you will also be asked to follow a 3 day, 300 g high carbohydrate diet for the 3 days prior to the study. You will be asked a brief history of your medical conditions and undergo a brief physical examination. You will be asked to complete a questionnaire about your social, family and medical history including your reproductive history (if applicable) and your current condition. You may be asked to provide authorization to obtain your birth records.  Every volunteer is asked to begin with individual blood tests. The baseline blood test will determine whether you qualify for further study.  You will  have an oral glucose tolerance test (OGTT). If you are a PCOS proband you will have the option of having and ACTH stimulation test. If you are a PCOS proband or female family member you will have the option of having a vaginal ultrasound.

Study Dates, Times and Location

Study Available by Appointment?: Yes
Location: Milton S. Hershey Medical Center, Hershey, Pa
Approximate Participant Study Length: 3 Hours

The study will take place over approximately a three hour period in the General Clinical Research Center.  The patient will have all study related testing testing done at this time to include: vaginal ultrasound, blood draw, and urine sample collection.  In addition, height, weight, and blood pressure measurements will be obtained.

Compensation: $25

Contact Information

Barb Scheetz
717-531-4483
Bscheetz@hmc.psu.edu

This study has been approved by a Penn State Institutional Review Board (IRB). IRB Approval Number 94-088