Clinical Trial: Acupuncture in the Regulation of Dai Meridian for Polycystic Ovarian Syndrome Patients With Abdominal Obesity

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Acupuncture in the Regulation of Dai Meridian for Polycystic Ovarian Syndrome Patients With Abdominal Obesity

Brief Summary: The purpose of this study is to determine whether the use of electroacupuncture to dredge and regulate Dai Meridian combined with lifestyle modification are more effective than lifestyle modification only in the treatment of anovulation and hyperandrogenism due to polycystic ovary syndrome (PCOS) with abdominal obesity.Two thirds of participants will receive electroacupuncture and lifestyle modification in combination, while the other one third will receive lifestyle modification only.

Detailed Summary:

Obesity, especially abdominal obesity, is one of most common clinical features of polycystic ovary syndrome, a widely and seriously influenced complex disorder related to reproduction and metabolism. Excessive accumulation of adipose tissue in the abdominal organs often leads to insulin resistance, which will increase the harm of hyperandrogenism and exacerbate ovulation disorders and metabolic abnormalities.

Weight loss, likely beneficial for both reproductive and metabolic dysfunction in this setting , has been generally recommended as a first-line therapy for obese women with PCOS and can be accomplished via lifestyle modification and electroacupuncture. What's more, stimulating acupoints of Dai Meridian can regulate menstrual cycles and treat infertility according to the theory of traditional Chinese medicine. However, how much benefits patients will additionally get from the Combined therapy is not clear now.


Sponsor: Dongfang Hospital Affiliated to Beijing University of Chinese Medicine

Current Primary Outcome: rate of recovered ovulation [ Time Frame: 12 weeks ]

the proportion of patients who have ovulation after treatment


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • evidence of clinically definite hyperandrogenism confirmed by mF-G score [ Time Frame: 12 weeks ]
  • evidence of clinically definite hyperandrogenism confirmed by the Global Acne Grading System [ Time Frame: 12 weeks ]
  • frequency of menstruation [ Time Frame: 12 weeks ]
  • quantity of menstruation [ Time Frame: 12 weeks ]
    pictorial blood loss assessment chart
  • Serum total testosterone (T) [ Time Frame: 12 weeks ]
  • FSH [ Time Frame: 12 weeks ]
    follicle stimulating hormone (FSH)
  • LH [ Time Frame: 12 weeks ]
    luteinizing hormone (LH)
  • ovarian volume measured by ultrasound [ Time Frame: 12 weeks ]
  • follicle number pre ovary measured by ultrasound [ Time Frame: 12 weeks ]
  • ovarian stromal blood flow measured by ultrasound [ Time Frame: 12 weeks ]
  • body weight in kilograms [ Time Frame: 4, 8 and 12 weeks ]
  • waist circumference in centimeter [ Time Frame: 4, 8 and 12 weeks ]
  • BMI in kg/m^2 [ Time Frame: 4, 8 and 12 weeks ]
  • waist-to-height ratio [ Time Frame: 4, 8 and 12 weeks ]
    waist-to-height ratio=waist circumference in centimeter/height in centimeter
  • Fasting serum PAI-1 level [ Time Frame: 12 weeks ]
  • International physical activity scale (IPAQ) short version [ Time Frame: 4, 8 and 12 weeks ]


Original Secondary Outcome:

  • evidence of clinically definite hyperandrogenism confirmed by mF-G score [ Time Frame: 12 weeks ]
  • evidence of clinically definite hyperandrogenism confirmed by the Global Acne Grading System [ Time Frame: 12 weeks ]
  • frequency of menstruation [ Time Frame: 12 weeks ]
  • quantity of menstruation [ Time Frame: 12 weeks ]
    pictorial blood loss assessment chart
  • Serum total testosterone (T) [ Time Frame: 12 weeks ]
  • LH/FSH [ Time Frame: 12 weeks ]
    luteinizing hormone (LH), follicle stimulating hormone (FSH)
  • ovarian volume measured by ultrasound [ Time Frame: 12 weeks ]
  • follicle number pre ovary measured by ultrasound [ Time Frame: 12 weeks ]
  • ovarian stromal blood flow measured by ultrasound [ Time Frame: 12 weeks ]
  • body weight in kilograms [ Time Frame: 4, 8 and 12 weeks ]
  • waist circumference in centimeter [ Time Frame: 4, 8 and 12 weeks ]
  • BMI in kg/m^2 [ Time Frame: 4, 8 and 12 weeks ]
  • waist-to-height ratio [ Time Frame: 4, 8 and 12 weeks ]
    waist-to-height ratio=waist circumference in centimeter/height in centimeter
  • Fasting serum PAI-1 level [ Time Frame: 12 weeks ]
  • International physical activity scale (IPAQ) short version [ Time Frame: 4, 8 and 12 weeks ]


Information By: Dongfang Hospital Affiliated to Beijing University of Chinese Medicine

Dates:
Date Received: May 23, 2016
Date Started: July 2016
Date Completion: September 2019
Last Updated: July 4, 2016
Last Verified: July 2016