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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Does Low-frequency Electro-acupuncture Restore Sensitivity of the Gonadotropin-releasing Hormone Pulse Generator and Stress Axis in Polycystic Ovary Syndrome

Conditions
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Polycystic Ovary Syndrome

Intervention / Treatment
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* Device: Low-frequency electro-acupuncture (EA)
* Other: Meeting a therapist - attention control


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 39 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Low-frequency electro-acupuncture<br> | Device: Low-frequency electro-acupuncture (EA)<br>* 2 Hz EA during 30 minutes, twice a week, 14 weeks.<br>|
| Active Comparator: Meeting a therapist - attention<br> | Other: Meeting a therapist - attention control<br>* Meeting a therapist, twice a week during 30 minutes in order to control for the increased amount of attention.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. |  | 16 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ovulation, health related quality of life |  | 16 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Luteinizing hormone, Cortisol, HPA axis, HPO axis, Ovulation, Heart rate variability, Psychological distress and quality of life