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Acupuncture for Polycystic Ovarian Syndrome

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ClinicalTrials.gov Identifier: NCT00602940
Recruitment Status : Unknown
Verified May 2010 by University of Virginia.
Recruitment status was:  Active, not recruiting
First Posted : January 28, 2008
Last Update Posted : May 21, 2010
Information provided by:
University of Virginia

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

Condition or disease Intervention/treatment
Polycystic Ovary Syndrome Procedure: Acupuncture Procedure: Sham Acupuncture

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 78 participants
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
Study Start Date : January 2006
Estimated Primary Completion Date : December 2009
Estimated Study Completion Date : December 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. ovulation in 2 out of 5 months of study participation [ Time Frame: monthly ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 43 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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

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

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

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 Posted: January 28, 2008    Key Record Dates
Last Update Posted: May 21, 2010
Last Verified: May 2010

Keywords provided by University of Virginia:

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