Acupuncture for Polycystic Ovarian Syndrome

May 20, 2010 updated by: University of Virginia

The Influence of Acupuncture on Ovulation and Reproductive Hormones

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

78

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Virginia
      • Charlottesville, Virginia, United States, 22908
        • University of Virginia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 43 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
ovulation in 2 out of 5 months of study participation
Time Frame: monthly
monthly

Secondary Outcome Measures

Outcome Measure
Time Frame
changes in follicle stimulating hormone and luteinizing hormone
Time Frame: baseline vs. 2 months vs. 5 months
baseline vs. 2 months vs. 5 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Virginia

Investigators

  • Principal Investigator: Lisa M Pastore, PhD, UVA OB/GYN Department

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2006

Primary Completion (Anticipated)

December 1, 2009

Study Completion (Anticipated)

December 1, 2010

Study Registration Dates

First Submitted

January 15, 2008

First Submitted That Met QC Criteria

January 26, 2008

First Posted (Estimate)

January 28, 2008

Study Record Updates

Last Update Posted (Estimate)

May 21, 2010

Last Update Submitted That Met QC Criteria

May 20, 2010

Last Verified

May 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 12045 (Registry Identifier: DAIDS-ES Registry Number)
  • NIH R21 AT002520

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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