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Study of Acupuncture to Control Weight and Improve Pregnancy Rates in Overweight/Obese PCOS Patients

ConditionsPolycystic Ovary SyndromeMetforminAcupuncture
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-40
SponsorRenJi Hospital

About this trial

Polycystic ovary syndrome (PCOS) is the most common cause of anovulatory infertility and is characterized by ovulatory dysfunction, increased androgens, and polycystic ovaries. The goal of this randomized control study is to compare the efficacy between acupuncture and metformin both with intensive lifestyle intervention for overweight /obese PCOS patients in weight and pregnancy rates improvement.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Diagnosis of PCOS according to the 2003 Rotterdam criteria with at least two of the following three symptoms: clinical and/or biochemical signs of hyperandrogenism (hirsutism or acne), oligomerism/amenorrhea, and/or polycystic ovaries (PCOS). Biochemical hyperandrogenism is defined as total testosterone > 2.6 nmol/L or free androgen index >7. Hirsutism is defined as an FG score ≥7. Oligomenorrhea is defined as menstrual bleeding > 35 days between menstrual periods in the past year, < 8 menstrual bleeding. Amenorrhea is < 3 cycles per year. PCO is defined by transvaginal ultrasound, where one or both ovaries ≥ 12 follicles 2-9 mm and/or ovarian volume ≥ 10 mL. Other endocrine disorders such as atypical congenital adrenal hyperplasia (17-hydroxyprogesterone <3 nmol/L), androgen-secreting tumors, or suspected Cushing syndrome are excluded.

Age from ≥ 20 years old (legal age of marriage) to ≤ 40 years old

PCOS patients: BMI ≥ 25 to ≤40kg/m2.

Willing to sign the consent form.

Disqualifiers

History of severe heart disease, hematologic disease;

Known kidney disease (creatinine clearance rate <45mL/min), liver function ALT, AST more than 3 times the normal value, autoimmune disease or cancer;

Any acute disease that has the potential to alter renal function or cause tissue hypoxia;

Type I diabetes mellitus;

Trial design

Design model

Parallel

Treatments tested in this trial

  • Acupuncture+lifestyle intervention

    Other intervention

    8 weeks Acupuncture treatment for 2-3 times/week, 30min each time and lifestyle intervention((1) Daily intake of 1200\~1500kcal of energy, dietary carbohydrate function ratio of 45-55%, lipid energy supply ratio of 20-30%, protein energy ratio of 20-30% (2) At least 150 minutes of moderate-intensity physical activity (e.g., brisk walking) per week (3) Quit smoking and drinking, and adjust psychologically)

  • Metformin+lifestyle intervention

    Other intervention

    8 weeks Metformin 500 mg three times a day with meals and lifestyle intervention ((1) Daily intake of 1200\~1500kcal of energy, dietary carbohydrate function ratio of 45-55%, lipid energy supply ratio of 20-30%, protein energy ratio of 20-30% (2) At least 150 minutes of moderate-intensity physical activity (e.g., brisk walking) per week (3) Quit smoking and drinking, and adjust psychologically)

Treatment groups

92 Participants
are divided into 2 treatment groups
Group A: acupuncture+ intensive lifestyle interventionExperimental treatment 1 intervention
Group B: metformin + intensive lifestyle interventionActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

the level of body fat distribution

Compared with the baseline in two groups, the level of body fat distribution to evaluate weight control outcome

Time frame
up to 8 weeks
2

Pregnancy rates after intervention

Compared with the baseline in two groups, pregnancy rate is one of the index to evaluate reproductive outcome

Time frame
up to 1 year
3

Body mass index

Compared with the baseline in two groups, the level of body mass index to evaluate weight control outcome.

Time frame
up to 8 weeks

Secondary outcomes

1

Standardized TCM syndrome differentiation and classification of PCOS patients

Through the "tongue and pulse image, meridians, and constitution identification collection analyzer" (registration certificate number: Ji Machinery Note 20202200354), the standardized TCM syndrome differentiation and classification of PCOS patients was clarified.

Time frame
up to 8 weeks
2

Glucose metabolism

the area under the curve (AUC insulin), fasting insulin, glucose, computational homeostatic model assessment (HOMA)-IR and HOMA-B (i.e., isis β cell function) were calculated during the insulin-to-glucose tolerance test (OGTT)

Time frame
up to 8 weeks
3

Female menstrual pattern

Sex hormones, anti-mullerian hormone (AMH) and 21-day progesterone measurement

Time frame
up to 8 weeks
4

Intestinal bacteria microbiota

Such measurement is tested through gene and microbiota testing. Those who have taken antibiotics and live bacteria within one week are excluded.

Time frame
up to 8 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

RenJi Hospital

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: