Acupuncture and Gonadotropin-releasing Hormone Pulse Generator and Stress Axis in Polycystic Ovary Syndrome (PCOSLFEA)
|Polycystic Ovary Syndrome||Device: Low-frequency electro-acupuncture (EA) Other: Meeting a therapist - attention control|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (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|
- 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 ]
- Ovulation, health related quality of life [ Time Frame: 16 weeks ]
|Study Start Date:||February 2009|
|Study Completion Date:||December 2010|
|Primary Completion Date:||December 2010 (Final data collection date for primary outcome measure)|
|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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00921492
|Institute of Neuroscience and Physiology, Sahlgrenska Academy, Göteborg University|
|Göteborg, Sweden, 40530|