Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
Acupuncture for Polycystic Ovary Syndrome
This study is currently recruiting participants.
Verified by University of Virginia, August 2008
Sponsored by: University of Virginia
Information provided by: University of Virginia
ClinicalTrials.gov Identifier: NCT00602940
  Purpose

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


Condition Intervention
Polycystic Ovary Syndrome
 Procedure: Acupuncture
Procedure: Sham Acupuncture

MedlinePlus related topics: Acupuncture
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Parallel Assignment
Official Title: The Influence of Acupuncture on Ovulation and Reproductive Hormones

Further study details as provided by University of Virginia:

Primary Outcome Measures:
  • ovulation in 2 out of 5 months of study participation [ Time Frame: monthly ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • changes in follicle stimulating hormone and luteinizing hormone [ Time Frame: baseline vs. 2 months vs. 5 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 78
Study Start Date: January 2006
Estimated Study Completion Date: May 2009
Estimated Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental
Active acupuncture treatment
Procedure: Acupuncture
12 treatments over 8 weeks
2: Sham Comparator
Sham acupuncture treatment
Procedure: Sham Acupuncture
12 treatments over 8 weeks

  Eligibility

Ages Eligible for Study:   18 Years to 43 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00602940

Contacts
Contact: Lisa M Pastore, PhD 434-924-9921 acup_for_pcos@virginia.edu
Contact: Parchayi Dalal, MPH 434-982-6657 acup_for_pcos@virginia.edu

Locations
United States, Virginia
University of Virginia Recruiting
Charlottesville, Virginia, United States, 22908
Sponsors and Collaborators
University of Virginia
Investigators
Principal Investigator: Lisa M Pastore, PhD UVA OB/GYN Department
  More Information

Responsible Party: UVA ( Lisa M. Pastore )
Study ID Numbers: IRBHSR12045, NIH R21 AT002520
Study First Received: January 15, 2008
Last Updated: August 6, 2008
ClinicalTrials.gov Identifier: NCT00602940  
Health Authority: United States: Institutional Review Board

Keywords provided by University of Virginia:
PCOS
ovulation
hormones
women

Study placed in the following topic categories:
Genital Diseases, Female
Gonadal Disorders
Polycystic Ovary Syndrome
Endocrine System Diseases
 Endocrinopathy
Ovarian Diseases
Cysts
Ovarian Cysts

Additional relevant MeSH terms:
Neoplasms
Pathologic Processes
Disease
Syndrome
Adnexal Diseases

ClinicalTrials.gov processed this record on January 14, 2009



U.S. National Library of Medicine,  Contact Help Desk
U.S. National Institutes of Health,  U.S. Department of Health & Human Services,
USA.gov,  Copyright,  Privacy,  Accessibility,  Freedom of Information Act

U.S. National Institutes of Health U.S. National Library of Medicine U.S. Department of Health & Human Services