This study evaluates the efficacy and safety in improving ovarian function of polycystic ovarian syndrome in adults. Half of patients will receive Tung's acupuncture therapy, while the other half will receive Diane-35(CPA/EE) as the control group.
Both Tung's acupuncture therapy and Diane-35(CPA/EE) could improve the symptom of patients with polycystic ovarian syndrome, but until now there is no definite evidence to indicate acupuncture could play the same role in improving ovarian function. So we design this study to observe the change of follicular development, ovary size and sex hormone( testosterone, follitropin, luteinizing hormone) before and after the treatment, and evaluate the efficacy and safty of acupuncture.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
60
The study took Tung's acupoints as main acupuncture points, which were Fuke, Huanchao, Tianhuang, Renhuang, as well as the traditional acupoints Guanyuan (CV4) and Zigong (EX-CA1).
Cyproterone acetate/ethinylestradiol (CPA/EE) contains 2mg cyproterone acetate (an anti-androgenic progestin) and 0.035mg ethinylestradiol (CPA/EE). The pills were administered for 21 days consecutively. The patients then stopped taking the pills for seven days and, on the eighth day, continued to take the pills again for three menstrual cycles (28 day cycles).
Beijing Hospital of Integrated Traditional Chinese and Western Medicine
Beijing, Beijing Municipality, China
Change in LH/FSH Ratio From Baseline to the End of Treatment
the change in LH/FSH ratio, values after 12-week treatment minus the values at baseline
Time frame: baseline and 12 weeks
Change in LH/FSH Ratio From Baseline to the 24th Week
the change in LH/FSH ratio, values at the 24th week minus the values at baseline
Time frame: baseline to the 24th week
Changes in LH From Baseline to the End of Treatment
changes in luteinizing hormone(LH), values after 12-week treatment minus the values at baseline
Time frame: baseline and 12 weeks
Changes in FSH From Baseline to the End of Treatment
changes in follicle-stimulating hormone (FSH), values after 12-week treatment minus the values at baseline
Time frame: baseline and 12 weeks
Changes in Body Mass Index (BMI) From Baseline to the End of Treatment
the changes in BMI, values after 12-week treatment minus the values at baseline
Time frame: baseline and 12 weeks
Changes in Total Testosterone (TT) From Baseline to the End of Treatment
changes in total testosterone (TT) , values after 12-week treatment minus the values at baseline
Time frame: baseline and 12 weeks
Changes in Ovarian Volume From Baseline to the End of Treatment
changes in ovarian volume, values after 12-week treatment minus the values at baseline
Time frame: baseline and 12 weeks
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Changes in Polycystic Ovary Number From Baseline to the End of Treatment
the changes in polycystic ovary number, values after 12-week treatment minus the values at baseline
Time frame: baseline and 12 weeks
Changes in the Number of Bleeding Events From Baseline to the End of Treatment
Changes in the number of bleeding events, values after 12-week treatment minus the values at baseline
Time frame: baseline and 12 weeks