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GCRC Trial Listing

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Protocol Title: The Influence of Acupuncture on Reproductive Hormones and Ovulation

Description of Study: UVa Health System, Department of Obstetrics and Gynecology, seeks female volunteers, ages 18 to 43, with Polycystic Ovary Syndrome (PCOS) for research study. PCOS symptoms may include unwanted facial and body hair, infrequent periods, and weight gain. The purpose of the study is to test whether acupuncture helps to return periods (and the related hormones) to normal. The study involves 16 outpatient visits over 5 months. Participants will be assigned by chance to either an acupuncture group or a placebo-acupuncture group. The study includes glucose (sugar) fasting tests, blood draws, urine pregnancy tests and questionnaires. Study-related exams, tests, parking and three meals are provided free of change. Compensation for study completion is $170.00. Principal Investigator: Lisa Pastore, PhD.

In-Patient or Out-Patient Protocol: Out
Number of In-Patient visits to the GCRC: 0
Number of days per In-Patient visit: 0
Number of Out-Patient visits to the GCRC: 4

Gender: F Age range: Over18

Medications that will be administered during this protocol: None

Inclusion and/or exclusion criteria: Inclusion: Women will be enrolled if they have or are suspected of having PCOS as defined in the study protocol/Agreement not to take hormonal contraceptives, metformin of fertility medications for the 5 months of study participation/Signed consent to participate in the study/Able to receive acupuncture treatment in Charlottesville for the next 2 months. Exclusion: Diabetes mellitus/Cushing’s Syndrome/uncontrolled thyroid disease/ hyperprolactinemia/ congenital adrenal hyperplasia/Currently pregnant/Use of metformin or hormonal contraceptives in the 60 days prior to entry into study/Use of any hormonal drug in the 30 days prior to entry into study/No menstrual bleeding within the last 6 months/Any acupuncture treatment for ovulatory disorders in the prior 30 days/Weight > 250 pounds/Immune deficiency/Any bleeding disorder

Procedures required for this protocol: Glucose (sugar) fasting tests/blood draws/urine pregnancy tests/questionnaires.

Clinical Department associated with protocol: Obstetrics & Gynecology

Field of study associated with protocol: Women's Health Research

Monetary compensation for completing study: 170
Other (non-monetary) compensation: Three free meals, parking paid

HIC Number: 12045
Study Coordinator Contact Information:
Name:
 Parchayi Dalal   Phone: (434) 982-6657   email: ACUP_FOR_PCOS@virginia.edu

Are you interested in this protocol?
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