Acupuncture and Gonadotropin-releasing Hormone Pulse Generator and Stress Axis in Polycystic Ovary Syndrome (PCOSLFEA)
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|ClinicalTrials.gov Identifier: NCT00921492|
Recruitment Status : Completed
First Posted : June 16, 2009
Last Update Posted : October 7, 2011
|Condition or disease||Intervention/treatment||Phase|
|Polycystic Ovary Syndrome||Device: Low-frequency electro-acupuncture (EA) Other: Meeting a therapist - attention control||Not Applicable|
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|
|Actual Primary Completion Date :||December 2010|
|Actual 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|