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

NCT06717087 | Not Yet Recruiting

• 1 other identifier: IIT-2023-0156
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Polycystic Ovary Syndrome; Metformin; Acupuncture

Outcome Measures

Primary Outcomes (3)

• the level of body fat distribution

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

  up to 8 weeks

• Pregnancy rates after intervention

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

  up to 1 year

• Body mass index

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

  up to 8 weeks

Secondary Outcomes (4)

• Standardized TCM syndrome differentiation and classification of PCOS patients

  up to 8 weeks

• Glucose metabolism

  up to 8 weeks

• Female menstrual pattern

  up to 8 weeks

• Intestinal bacteria microbiota

  up to 8 weeks

Study Arms (2)

acupuncture+ intensive lifestyle intervention

EXPERIMENTAL

8 weeks acupuncture+ intensive lifestyle intervention

Other: Acupuncture+lifestyle intervention

metformin + intensive lifestyle intervention

ACTIVE COMPARATOR

8 weeks metformin treatment(metformin 500 mg three times a day with meals)+ intensive lifestyle intervention

Other: Metformin+lifestyle intervention

Interventions

Acupuncture+lifestyle intervention OTHER

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)

Also known as: group 1(Pulse Acupuncture and Moxibustion Therapeutic Instrument:KWD-808I,KWD-808II,KWD-808III )

acupuncture+ intensive lifestyle intervention

Metformin+lifestyle intervention OTHER

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)

Also known as: group 2

metformin + intensive lifestyle intervention

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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;
• Medication within 12 weeks (hormonal drugs, antidepressants, other anti-diabetic drugs, contraceptives, ovulation induction drugs or other drugs that affect the trial in the judgment of the investigator);
• Allergy to metformin hydrochloride or any excipients;
• Blood pressure \> 160/100 mm Hg;
• Pregnancy or breastfeeding in the past three months;
• No history of acupuncture treatment within 2 months;
• Alcohol dependence
• Persons with disabilities with language impairment or reduced ability to understand the information provided;
• Those who have participated in other clinical studies within three months;
• The man clearly diagnoses infertility-related diseases and factors.

Sponsors & Collaborators

• RenJi Hospital: lead

Study Sites (1)

Renji Hospital, School of Medicine, Shanghai Jiaotong University

Shanghai, 200127, China

Location

MeSH Terms

Conditions

Polycystic Ovary Syndrome

Condition Hierarchy (Ancestors)

Ovarian Cysts; Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases

Study Officials

• Tao Tao, MD

  RenJi Hospital Department of Endocrinology and Metabolism

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tao Tao, MD

CONTACT

+86-13817701776; taotaozhen@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 24, 2024
• First Posted: December 4, 2024
• Study Start: December 20, 2024
• Primary Completion: August 1, 2025
• Study Completion (Estimated): June 1, 2026
• Last Updated: December 4, 2024

Record last verified: 2024-11

Locations

CN (1)