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Acupuncture and Gonadotropin-releasing Hormone Pulse Generator and Stress Axis in Polycystic Ovary Syndrome (PCOSLFEA)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Elisabet Stener-Victorin, Göteborg University
ClinicalTrials.gov Identifier:
NCT00921492
First received: June 12, 2009
Last updated: October 6, 2011
Last verified: October 2011
History of Changes
  Purpose

Hypothesis The overall hypothesis is that non-obese (BMI <30) women with PCOS have high luteinising hormone (LH) and cortisol pulse frequency and amplitude and that repeated low-frequency EA restore these alterations and induce ovulation.


Condition Intervention
Polycystic Ovary Syndrome
 Device: Low-frequency electro-acupuncture (EA)
Other: Meeting a therapist - attention control

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Does Low-frequency Electro-acupuncture Restore Sensitivity of the Gonadotropin-releasing Hormone Pulse Generator and Stress Axis in Polycystic Ovary Syndrome

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Göteborg University:

Primary Outcome Measures:
  • Frequent blood sampling every 10th minute during an overnight stay in order to measure changes in LH and cortisol pulsatility before and after treatment. A third assessment will be made in those participants who ovulate during the 14 week study. [ Time Frame: 16 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Ovulation, health related quality of life [ Time Frame: 16 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 28
Study Start Date: February 2009
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Low-frequency electro-acupuncture Device: Low-frequency electro-acupuncture (EA)
2 Hz EA during 30 minutes, twice a week, 14 weeks.
Active Comparator: Meeting a therapist - attention Other: Meeting a therapist - attention control
Meeting a therapist, twice a week during 30 minutes in order to control for the increased amount of attention.

Detailed Description:

Aim 1. Elucidate if low-frequency EA induce ovulation and restore LH frequency and amplitude as well as sex steroid secretion as compared to a control group receiving same amount of attention.

Aim 2. Elucidate if low-frequency EA restore cortisol frequency and amplitude compared to a control group receiving same amount of attention.

Aim 3. Elucidate if low-frequency EA restore psychological distress and quality of life as compared to a control group receiving same amount of attention.in women with PCOS.

  Eligibility

Ages Eligible for Study:   18 Years to 39 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18 - 39 years, inclusive
  • 30 ≤ BMI
  • History of irregular menstrual cycles
  • Clinical and/or biochemical androgen excess (determined during screening)

Exclusion Criteria:

Medical Exclusion Criteria

  • History or clinical manifestation of; cardiovascular disease, diabetes (Type 1 or Type 2), any other significant endocrine or metabolic disorder.
  • Regular use of medications for weight control, psychosis and thyroid disease. A 3 month washout period will be permitted for contraceptives.

Psychiatric and Behavioral Exclusion Criteria

  • Pregnant or breast-feeding women
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00921492

Locations
Sweden
Institute of Neuroscience and Physiology, Sahlgrenska Academy, Göteborg University
Göteborg, Sweden, 40530
Sponsors and Collaborators
Göteborg University
  More Information

No publications provided

Responsible Party: Elisabet Stener-Victorin, PhD, Researcher, Göteborg University
ClinicalTrials.gov Identifier: NCT00921492     History of Changes
Other Study ID Numbers: PCOSLFEA-17611, 2008-72VP-15445-01A, ALFFGBG-10984
Study First Received: June 12, 2009
Last Updated: October 6, 2011
Health Authority: Sweden: Regional Ethical Review Board
Sweden: Swedish Research Council

Keywords provided by Göteborg University:
Luteinizing hormone
Cortisol
HPA axis
HPO axis
 Ovulation
Heart rate variability
Psychological distress and quality of life

Additional relevant MeSH terms:
Polycystic Ovary Syndrome
Ovarian Cysts
Cysts
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
 Gonadal Disorders
Endocrine System Diseases
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 22, 2013