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Acupuncture for Polycystic Ovarian Syndrome

Primary Purpose

Polycystic Ovary Syndrome

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Acupuncture
Sham Acupuncture
Sponsored by
University of Virginia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Polycystic Ovary Syndrome focused on measuring PCOS, ovulation, hormones, women

Eligibility Criteria

18 Years - 43 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • University of Virginia

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

1

2

Arm Description

Active acupuncture treatment

Sham acupuncture treatment

Outcomes

Primary Outcome Measures

ovulation in 2 out of 5 months of study participation

Secondary Outcome Measures

changes in follicle stimulating hormone and luteinizing hormone

Full Information

First Posted
January 15, 2008
Last Updated
May 20, 2010
Sponsor
University of Virginia
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1. Study Identification

Unique Protocol Identification Number
NCT00602940
Brief Title
Acupuncture for Polycystic Ovarian Syndrome
Official Title
The Influence of Acupuncture on Ovulation and Reproductive Hormones
Study Type
Interventional

2. Study Status

Record Verification Date
May 2010
Overall Recruitment Status
Unknown status
Study Start Date
January 2006 (undefined)
Primary Completion Date
December 2009 (Anticipated)
Study Completion Date
December 2010 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
University of Virginia

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Polycystic Ovary Syndrome
Keywords
PCOS, ovulation, hormones, women

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
78 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Active acupuncture treatment
Arm Title
2
Arm Type
Sham Comparator
Arm Description
Sham acupuncture treatment
Intervention Type
Procedure
Intervention Name(s)
Acupuncture
Intervention Description
12 treatments over 8 weeks
Intervention Type
Procedure
Intervention Name(s)
Sham Acupuncture
Intervention Description
12 treatments over 8 weeks
Primary Outcome Measure Information:
Title
ovulation in 2 out of 5 months of study participation
Time Frame
monthly
Secondary Outcome Measure Information:
Title
changes in follicle stimulating hormone and luteinizing hormone
Time Frame
baseline vs. 2 months vs. 5 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
43 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lisa M Pastore, PhD
Organizational Affiliation
UVA OB/GYN Department
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Virginia
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
21911106
Citation
Pastore LM, Patrie JT, Morris WL, Dalal P, Bray MJ. Depression symptoms and body dissatisfaction association among polycystic ovary syndrome women. J Psychosom Res. 2011 Oct;71(4):270-6. doi: 10.1016/j.jpsychores.2011.02.005. Epub 2011 Mar 23.
Results Reference
derived

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Acupuncture for Polycystic Ovarian Syndrome

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