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

Study Overview
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Brief Summary
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Hypothesis: 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.

Detailed Description
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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.

Official Title
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Polycystic Ovary Syndrome (PCOS) - The Female Metabolic Syndrome Genes And Processes In The Aetiology And Pathogenesis Of PCOS And Identification Of New Treatment Strategies

Conditions
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Polycystic Ovary Syndrome

Intervention / Treatment
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* Procedure: Electroacupuncture
* Procedure: Physical exercise
* Procedure: Untreated control


Participation Criteria
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Eligibility Criteria
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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: Anovulation/oligoovulation defined as ≥ 35 days during the last year 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 37 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Low-frequency electro-acupuncture<br> | Procedure: Electroacupuncture<br> <br> |
| Experimental: Physical exercise<br> | Procedure: Physical exercise<br> <br> |
| Active Comparator: Untreated control<br> | Procedure: Untreated control<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. |  | One year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Androgens, Menstrual pattern, Insulin resistance, Adipocytes, Obesity, Stress, Muscle sympathetic nerve activity, Psychological distress and quality of life