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Acupuncture for Polycystic Ovarian Syndrome

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified May 2010 by University of Virginia.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00602940
First Posted: January 28, 2008
Last Update Posted: May 21, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
University of Virginia
  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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Influence of Acupuncture on Ovulation and Reproductive Hormones

Resource links provided by NLM:


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 ]

Secondary Outcome Measures:
  • changes in follicle stimulating hormone and luteinizing hormone [ Time Frame: baseline vs. 2 months vs. 5 months ]

Estimated Enrollment: 78
Study Start Date: January 2006
Estimated Study Completion Date: December 2010
Estimated Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Active acupuncture treatment
Procedure: Acupuncture
12 treatments over 8 weeks
Sham Comparator: 2
Sham acupuncture treatment
Procedure: Sham Acupuncture
12 treatments over 8 weeks

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 43 Years   (Adult)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00602940


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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Lisa M. Pastore, UVA
ClinicalTrials.gov Identifier: NCT00602940     History of Changes
Other Study ID Numbers: 12045
NIH R21 AT002520
First Submitted: January 15, 2008
First Posted: January 28, 2008
Last Update Posted: May 21, 2010
Last Verified: May 2010

Keywords provided by University of Virginia:
PCOS
ovulation
hormones
women

Additional relevant MeSH terms:
Syndrome
Polycystic Ovary Syndrome
Disease
Pathologic Processes
Ovarian Cysts
Cysts
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases


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