Acupuncture for Polycystic Ovarian Syndrome

Polycystic Ovary Syndrome Clinical Trial

Official title:

The Influence of Acupuncture on Ovulation and Reproductive Hormones

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00602940
• Other study ID #: 12045
• Secondary ID: NIH R21 AT002520
• Status: Active, not recruiting
• Phase: N/A
• First received: January 15, 2008
• Last updated: May 20, 2010
• Start date: January 2006
• Est. completion date: December 2010

Study information

• 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

Clinical Trial Summary

This is a randomized control trial of acupuncture for women with polycystic ovary syndrome. The study is triple-blinded.

Recruitment information / eligibility

• 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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Polycystic Ovary Syndrome

Intervention

Procedure:
• Acupuncture
12 treatments over 8 weeks
• Sham Acupuncture
12 treatments over 8 weeks

Locations

Country	Name	City	State
United States	University of Virginia	Charlottesville	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
University of Virginia

Country where clinical trial is conducted

United States, 

Outcome

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