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

Primary Purpose

Polycystic Ovary Syndrome

Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Low-frequency electro-acupuncture (EA)
Meeting a therapist - attention control
Sponsored by
Göteborg University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Polycystic Ovary Syndrome focused on measuring Luteinizing hormone, Cortisol, HPA axis, HPO axis, Ovulation, Heart rate variability, Psychological distress and quality of life

Eligibility Criteria

18 Years - 39 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Institute of Neuroscience and Physiology, Sahlgrenska Academy, Göteborg University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Low-frequency electro-acupuncture

Meeting a therapist - attention

Arm Description

Outcomes

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.

Secondary Outcome Measures

Ovulation, health related quality of life

Full Information

First Posted
June 12, 2009
Last Updated
August 13, 2018
Sponsor
Göteborg University
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1. Study Identification

Unique Protocol Identification Number
NCT00921492
Brief Title
Acupuncture and Gonadotropin-releasing Hormone Pulse Generator and Stress Axis in Polycystic Ovary Syndrome
Acronym
PCOSLFEA
Official Title
Does Low-frequency Electro-acupuncture Restore Sensitivity of the Gonadotropin-releasing Hormone Pulse Generator and Stress Axis in Polycystic Ovary Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
February 2009 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
December 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Göteborg University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Polycystic Ovary Syndrome
Keywords
Luteinizing hormone, Cortisol, HPA axis, HPO axis, Ovulation, Heart rate variability, Psychological distress and quality of life

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
28 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Low-frequency electro-acupuncture
Arm Type
Experimental
Arm Title
Meeting a therapist - attention
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
Low-frequency electro-acupuncture (EA)
Intervention Description
2 Hz EA during 30 minutes, twice a week, 14 weeks.
Intervention Type
Other
Intervention Name(s)
Meeting a therapist - attention control
Intervention Description
Meeting a therapist, twice a week during 30 minutes in order to control for the increased amount of attention.
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
Ovulation, health related quality of life
Time Frame
16 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
39 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Institute of Neuroscience and Physiology, Sahlgrenska Academy, Göteborg University
City
Göteborg
ZIP/Postal Code
40530
Country
Sweden

12. IPD Sharing Statement

Citations:
PubMed Identifier
23482444
Citation
Johansson J, Redman L, Veldhuis PP, Sazonova A, Labrie F, Holm G, Johannsson G, Stener-Victorin E. Acupuncture for ovulation induction in polycystic ovary syndrome: a randomized controlled trial. Am J Physiol Endocrinol Metab. 2013 May 1;304(9):E934-43. doi: 10.1152/ajpendo.00039.2013. Epub 2013 Mar 12.
Results Reference
derived

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

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