Electroacupuncture added to metformin treatment in patients with polycystic ovary syndrome and overweight

Not Applicable

• Conditions: Polycystic ovarian syndrome; Nutritional, Metabolic, Endocrine

• Registration Number: ISRCTN45111863
• Lead Sponsor: niversity of Indonesia and Cipto Mangunkusumo Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2018-08-31
• Study Start: 2020-08-18
• Last Update Posted: 21 July 2021

Recruitment & Eligibility

• Sex: Female
• Target Recruitment: 44

Inclusion Criteria

1. 18 - 40 years old
2. BMI > 23kg/m²
3. Volunteering to join this research and giving informed consent

Exclusion Criteria

1. Suffering from malignancy
2. Suffering from hypertension (blood pressure >140/90 mmHg, JNC 7 criteria)
3. Suffering from diabetes mellitus (fasting blood sugar >126 mg/dL, PERKENI 2015 criteria)
4. Currently in lactation
5. Suffering from endocrine disorders associated with steroid sex hormones such as congenital adrenal hyperplasia, Cushing’s syndrome, and androgen-secreting tumor diagnosed by a gynecologist
6. Currently undergoing pharmacological therapy related to dominant follicles stimulation such as clomiphene citrate, letrozole, FSH within 3 months
7. Subjects undergoing acupuncture therapy in the 12 weeks prior to recruitment
8. Subjects with absolute contraindications to electroacupuncture therapy such as: the first trimester of pregnancy, patients in a state of shock or coma, body temperature >38 degrees C, septicemia, tuberculosis of the skin or other local skin infection, heart rhythm disorders and patients with pacemakers, hypertension
9. Subjects with relative contraindications to electroacupuncture therapy such as: a history of epilepsy, pain and acute edema, and in patients with metal implants

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> 1. Menstrual cycle length is measured in days using interview at baseline (before 1st session) and the end of acupuncture sessions (after 12th session)<br> 2. Ovarian volume is measured in ml using transvaginal ultrasonography at baseline (before 1st session) and the end of acupuncture sessions (after 12th session)<br> 3. Number of antral follicles is measured using transvaginal ultrasonography at baseline (before 1st session) and the end of acupuncture sessions (after 12th session)<br>

Secondary Outcome Measures

Name	Time	Method
Menstruation occurrence is measured using interview at baseline (before 1st session) and the end of acupuncture sessions (after 12th session)