Acupuncture for Polycystic Ovarian Syndrome

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2010 by University of Virginia.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
University of Virginia
ClinicalTrials.gov Identifier:
NCT00602940
First received: January 15, 2008
Last updated: May 20, 2010
Last verified: May 2010
  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: Double Blind (Subject, 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 ] [ 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: 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

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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided by University of Virginia

Additional 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
Study First Received: January 15, 2008
Last Updated: May 20, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by University of Virginia:
PCOS
ovulation
hormones
women

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

ClinicalTrials.gov processed this record on October 23, 2014