The Efficacy and Safety Study of Tung's Acupuncture for Polycystic Ovarian Syndrome

Study Overview
=================
Brief Summary
-----------------
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.

Detailed Description
-----------------
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.

Official Title
-----------------
The Efficacy and Safety Study of Tung's Acupuncture for Improving Ovarian Function of Polycystic Ovarian Syndrome: a Randomised Controlled Trial

Conditions
-----------------
Polycystic Ovarian Syndrome

Intervention / Treatment
-----------------
* Other: Tung's acupuncture
* Drug: Cyproterone acetate/ethinylestradiol (CPA/EE)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Chinese; 18-45 years old; to meet the diagnostic criteria for polycystic ovary syndrome; no need for pregnancy in the next six months; volunteering to join this research and give informed consent prior to receiving treatment. Exclusion Criteria: hypertensive patients with blood pressure exceed 160/100 mmHg; a history of thrombosis,cerebrolvascular diseases, cancer, liver disease or liver dysfuction, hyperlipidemia, mental disorder, and severe infection; having taken any pharmacological treatments affecting reproductive endocrine system; having received acupuncture in the previous three months; smoking more than 15 cigarettes per day; having pacemakers, metal allergies or severe fear of acupuncture.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The study was a randomized, drug-controlled, and parallel group trial
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tung's acupuncture<br>The Tung's acupuncture group received acupuncture treatments twice per week for 12 weeks. 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). | Other: Tung's acupuncture<br>* 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).<br>|
| Active Comparator: CPA/EE<br>Cyproterone acetate/ethinylestradiol (CPA/EE) was taken orally one tablet per day from the 8th day of menstrual cycle or any day for patients with amenorrhea. 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). | Drug: Cyproterone acetate/ethinylestradiol (CPA/EE)<br>* 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).<br>* Other names: Diane-35;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | baseline and 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | 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 | 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 | 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 | 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 | baseline and 12 weeks | 
| 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 | 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 | baseline and 12 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
acupuncture, LH/FSH, total testosterone (TT), polycystic ovarian syndrome(PCOS)