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

Phase 2

Completed

• Conditions: Polycystic Ovarian Syndrome
• Interventions: Other: Tung's acupuncture; Drug: Cyproterone acetate/ethinylestradiol (CPA/EE)

• Registration Number: NCT02729545
• Lead Sponsor: Beijing Hospital of Integrated Traditional Chinese and Western Medicine

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.

Study Timeline

• Study First Submitted: 2016-03-29
• Study First Submitted QC: 2016-03-31
• Study Start: 2016-04
• Study First Posted: 2016-04-06
• Primary Completion: 2018-03
• Study Completion: 2018-05
• Results First Submitted: 2019-01-12
• Results First Submitted QC: 2019-08-18
• Status Verified: 2019-09
• Results First Posted: 2019-09-24
• Last Update Submitted: 2019-09-25
• Last Update Posted: 2019-10-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 60

Inclusion Criteria

1. Chinese;
2. 18-45 years old;
3. to meet the diagnostic criteria for polycystic ovary syndrome;
4. no need for pregnancy in the next six months;
5. volunteering to join this research and give informed consent prior to receiving treatment.

Exclusion Criteria

1. hypertensive patients with blood pressure exceed 160/100 mmHg;
2. a history of thrombosis,cerebrolvascular diseases, cancer, liver disease or liver dysfuction, hyperlipidemia, mental disorder, and severe infection;
3. having taken any pharmacological treatments affecting reproductive endocrine system;
4. having received acupuncture in the previous three months;
5. smoking more than 15 cigarettes per day;
6. having pacemakers, metal allergies or severe fear of acupuncture.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tung's acupuncture	Tung's acupuncture	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).
CPA/EE	Cyproterone acetate/ethinylestradiol (CPA/EE)	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).

Primary Outcome Measures

Name	Time	Method
Change in LH/FSH Ratio From Baseline to the End of Treatment	baseline and 12 weeks	the change in LH/FSH ratio, values after 12-week treatment minus the values at baseline

Secondary Outcome Measures

Name	Time	Method
Changes in FSH From Baseline to the End of Treatment	baseline and 12 weeks	changes in follicle-stimulating hormone (FSH), values after 12-week treatment minus the values at baseline
Changes in Polycystic Ovary Number From Baseline to the End of Treatment	baseline and 12 weeks	the changes in polycystic ovary number, values after 12-week treatment minus the values at baseline
Change in LH/FSH Ratio From Baseline to the 24th Week	baseline to the 24th week	the change in LH/FSH ratio, values at the 24th week minus the values at baseline
Changes in Body Mass Index (BMI) From Baseline to the End of Treatment	baseline and 12 weeks	the changes in BMI, values after 12-week treatment minus the values at baseline
Changes in Ovarian Volume From Baseline to the End of Treatment	baseline and 12 weeks	changes in ovarian volume, values after 12-week treatment minus the values at baseline
Changes in LH From Baseline to the End of Treatment	baseline and 12 weeks	changes in luteinizing hormone(LH), values after 12-week treatment minus the values at baseline
Changes in Total Testosterone (TT) From Baseline to the End of Treatment	baseline and 12 weeks	changes in total testosterone (TT) , values after 12-week treatment minus the values at baseline
Changes in the Number of Bleeding Events From Baseline to the End of Treatment	baseline and 12 weeks	Changes in the number of bleeding events, values after 12-week treatment minus the values at baseline

Trial Locations

Locations (1)

Beijing Hospital of Integrated Traditional Chinese and Western Medicine; 🇨🇳 Beijing, Beijing, China