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Completed

NCT Number: NCT00484705

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

electroacupuncture

Procedure

Physical exercise

Procedure

Untreated control

Procedure

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

Göteborg University

Other

Registry information

Official study 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

Acronym: PCOSNTS

Important dates

Study start
2005
Primary completion
2008
Study completion
2008
First posted
Jun 11, 2007
Registry last updated
Nov 10, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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