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Completed

NCT Number: NCT02729545

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

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.

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Key information

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Beijing Hospital of Integrated Traditional Chinese and Western Medicine

Beijing, Beijing Municipality, 100039, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Tung's acupuncture

Other

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)

Drug

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).

Other names: Diane-35

Primary outcomes

  1. Change in LH/FSH Ratio From Baseline to the End of Treatment

    Time frame: baseline and 12 weeks

    the change in LH/FSH ratio, values after 12-week treatment minus the values at baseline

Secondary outcomes

  1. Change in LH/FSH Ratio From Baseline to the 24th Week

    Time frame: baseline to the 24th week

    the change in LH/FSH ratio, values at the 24th week minus the values at baseline

  2. Changes in LH From Baseline to the End of Treatment

    Time frame: baseline and 12 weeks

    changes in luteinizing hormone(LH), values after 12-week treatment minus the values at baseline

  3. Changes in FSH From Baseline to the End of Treatment

    Time frame: baseline and 12 weeks

    changes in follicle-stimulating hormone (FSH), values after 12-week treatment minus the values at baseline

  4. Changes in Body Mass Index (BMI) From Baseline to the End of Treatment

    Time frame: baseline and 12 weeks

    the changes in BMI, values after 12-week treatment minus the values at baseline

  5. Changes in Total Testosterone (TT) From Baseline to the End of Treatment

    Time frame: baseline and 12 weeks

    changes in total testosterone (TT) , values after 12-week treatment minus the values at baseline

  6. Changes in Ovarian Volume From Baseline to the End of Treatment

    Time frame: baseline and 12 weeks

    changes in ovarian volume, values after 12-week treatment minus the values at baseline

  7. Changes in Polycystic Ovary Number From Baseline to the End of Treatment

    Time frame: baseline and 12 weeks

    the changes in polycystic ovary number, values after 12-week treatment minus the values at baseline

  8. Changes in the Number of Bleeding Events From Baseline to the End of Treatment

    Time frame: baseline and 12 weeks

    Changes in the number of bleeding events, values after 12-week treatment minus the values at baseline

Sponsors and collaborators

Lead sponsor

Beijing Hospital of Integrated Traditional Chinese and Western Medicine

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Apr 6, 2016
Registry last updated
Oct 8, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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