Acupuncture and Gonadotropin-releasing Hormone Pulse Generator and Stress Axis in Polycystic Ovary Syndrome (PCOSLFEA)
|ClinicalTrials.gov Identifier: NCT00921492|
Recruitment Status : Completed
First Posted : June 16, 2009
Last Update Posted : October 7, 2011
|Condition or disease||Intervention/treatment|
|Polycystic Ovary Syndrome||Device: Low-frequency electro-acupuncture (EA) Other: Meeting a therapist - attention control|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||28 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Does Low-frequency Electro-acupuncture Restore Sensitivity of the Gonadotropin-releasing Hormone Pulse Generator and Stress Axis in Polycystic Ovary Syndrome|
|Study Start Date :||February 2009|
|Primary Completion Date :||December 2010|
|Study Completion Date :||December 2010|
|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.
- 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 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00921492
|Institute of Neuroscience and Physiology, Sahlgrenska Academy, Göteborg University|
|Göteborg, Sweden, 40530|