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Polycystic Ovary Syndrome (PCOS) - Effect Of Physical Exercise And Electroacupuncture (PCOSNTS)

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. Identifier: NCT00484705
Recruitment Status : Completed
First Posted : June 11, 2007
Last Update Posted : November 10, 2009
Information provided by:
Göteborg University

Brief Summary:


The overall hypothesis is that women with PCOS, both obese and non-obese, have larger adipocytes, altered metabolism and signs of inflammation in adipose tissue and that these changes are associated with high sympathetic nerve activity, hyperandrogenism hyperinsulinaemia, insulin resistance with progression to type II diabetes and cardiovascular disease (CVD) as well as psychological distress and reduced quality of life. Physical exercise and electro-acupuncture decrease high concentrations of androgens, induce regulare menstrual pattern, inhibits high sympathetic activity and restore the PCOS induced disturbances.

Condition or disease Intervention/treatment Phase
Polycystic Ovary Syndrome Procedure: Electroacupuncture Procedure: Physical exercise Procedure: Untreated control Not Applicable

Detailed Description:

Primary outcome: Changes in androgen concentrations and menstrual pattern

Secondary outcome: changes in sympathetic nerve activity, uterus peristalsis, ovarian morphology, adipose tissue related variables, insulin sensitivity, coagulation factors and health related quality of life and symptoms of anxiety and depression.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 84 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single
Primary Purpose: Treatment
Official Title: Polycystic Ovary Syndrome (PCOS) - The Female Metabolic Syndrome Genes And Processes In The Aetiology And Pathogenesis Of PCOS And Identification Of New Treatment Strategies
Study Start Date : October 2005
Actual Primary Completion Date : October 2008
Actual Study Completion Date : October 2008

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Low-frequency electro-acupuncture Procedure: Electroacupuncture
Experimental: Physical exercise Procedure: Physical exercise
Active Comparator: Untreated control Procedure: Untreated control

Primary Outcome Measures :
  1. To measure if physical exercise and electro-acupuncture restores endocrine, neuroendocrine, metabolic and immunological disturbances related to sympathetic nerve activity as well as psychological distress and improve quality of life in women with PCOS. [ Time Frame: One year ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 37 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • To get the diagnosis polycystic ovary syndrome (PCOS), ultrasonography should reveal at least 1 ovary with PCO according to the Rotterdam diagnostic criteria as well as one of the following two symptoms:

    1. Anovulation/oligoovulation defined as ≥ 35 days during the last year
    2. Clinical signs of hyperandrogenism (hirsutism, acne)

Exclusion Criteria:

  • Cardiovascular disease
  • Diabetes mellitus
  • Other endocrine disease (congenital adrenal hyperplasia, androgen producing tumour, Cushing's syndrome)
  • Estrogen/gestagen treatment during the last 3 months
  • Breast-feeding the last 6 months
  • Antiandrogen treatment the last 3 months

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 identifier (NCT number): NCT00484705

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Institute of Neuroscience and Physiology, Sahlgrenska Academy, Göteborg University
Göteborg, Sweden, 405 30 Göteobrg
Sponsors and Collaborators
Göteborg University
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Principal Investigator: Elisabet Stener-Victorin, Prof, PhD Sahlgrenska Academy, Göteborg University
Publications automatically indexed to this study by Identifier (NCT Number):

Layout table for additonal information Identifier: NCT00484705    
Other Study ID Numbers: VGFOUREG-7861
Novo Nordisk Foundation
First Posted: June 11, 2007    Key Record Dates
Last Update Posted: November 10, 2009
Last Verified: November 2009
Keywords provided by Göteborg University:
Menstrual pattern
Insulin resistance
Muscle sympathetic nerve activity
Psychological distress and quality of life
Additional relevant MeSH terms:
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Polycystic Ovary Syndrome
Pathologic Processes
Ovarian Cysts
Ovarian Diseases
Adnexal Diseases
Gonadal Disorders
Endocrine System Diseases