Polycystic Ovary Syndrome Clinical Trial
Official title:
The Influence of Acupuncture on Ovulation and Reproductive Hormones
Verified date | May 2010 |
Source | University of Virginia |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
This is a randomized control trial of acupuncture for women with polycystic ovary syndrome. The study is triple-blinded.
Status | Active, not recruiting |
Enrollment | 78 |
Est. completion date | December 2010 |
Est. primary completion date | December 2009 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 43 Years |
Eligibility |
Inclusion Criteria: - ages 18-43 - confirmation of PCOS through the study - signed informed consent - able to receive study treatment at Virginia study sites - agree not to use hormonal medications for the 5 months of the study Exclusion Criteria: - pregnant - use of hormonal drugs 30/60 days before the study entry - acupuncture for ovulatory disorders 30 days prior to study entry |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | University of Virginia | Charlottesville | Virginia |
Lead Sponsor | Collaborator |
---|---|
University of Virginia |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | ovulation in 2 out of 5 months of study participation | monthly | No | |
Secondary | changes in follicle stimulating hormone and luteinizing hormone | baseline vs. 2 months vs. 5 months | No |
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