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

A Randomized Controlled Study of Acupuncture to Control Weight and Improve Pregnancy Rates in Overweight/Obese Polycystic Ovary Syndrome Patients

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Polycystic Ovary Syndrome; Acupuncture; Metformin
• Intervention / Treatment: Other: Acupuncture+lifestyle intervention; Other: Metformin+lifestyle intervention

Detailed Description

A randomized control study is designed to compare the efficacy of acupuncture and metformin with intensive lifestyle intervention for overweight /obese PCOS patients in weight and pregnancy rate improvement. 92 patients will be enrolled from Renji Hospital affiliated with Shanghai Jiao Tong University School of Medicine and will be divided into 2 groups: acupuncture+ intensive lifestyle intervention group and metformin + intensive lifestyle intervention group. Each group used a specific treatment (shown as the group name) for 8 weeks. In this study, the role of acupuncture in improving weight control and pregnancy rate in overweight/obese PCOS patients will be evaluated, the safety and efficacy of acupuncture as well as metabolic measurements. Molecular targets and models for predicting the sensitivity and prognosis of acupuncture treatment, as well as in-depth research on the molecular mechanism of acupuncture in treating PCOS, have a guiding significance and promote the modernization of traditional medicine.

• Study Type: Interventional
• Enrollment (Estimated): 92
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Tao Tao, MD; Phone Number: +86-13817701776; Email: taotaozhen@hotmail.com

Study Locations

• China
  • Shanghai, China, 200127
    • Renji Hospital, School of Medicine, Shanghai Jiaotong University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. 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.
2. Age from ≥ 20 years old (legal age of marriage) to ≤ 40 years old
3. PCOS patients: BMI ≥ 25 to ≤40kg/m2.
4. Willing to sign the consent form.

Exclusion Criteria:

1. History of severe heart disease, hematologic disease;
2. Known kidney disease (creatinine clearance rate <45mL/min), liver function ALT, AST more than 3 times the normal value, autoimmune disease or cancer;
3. Any acute disease that has the potential to alter renal function or cause tissue hypoxia;
4. Type I diabetes mellitus;
5. 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);
6. Allergy to metformin hydrochloride or any excipients;
7. Blood pressure > 160/100 mm Hg;
8. Pregnancy or breastfeeding in the past three months;
9. No history of acupuncture treatment within 2 months;
10. Alcohol dependence
11. Persons with disabilities with language impairment or reduced ability to understand the information provided;
12. Those who have participated in other clinical studies within three months;
13. The man clearly diagnoses infertility-related diseases and factors.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: acupuncture+ intensive lifestyle intervention; 8 weeks acupuncture+ intensive lifestyle intervention	Other: Acupuncture+lifestyle 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); Other Names: group 1(Pulse Acupuncture and Moxibustion Therapeutic Instrument:KWD-808I,KWD-808II,KWD-808III )
Active Comparator: metformin + intensive lifestyle intervention; 8 weeks metformin treatment(metformin 500 mg three times a day with meals)+ intensive lifestyle intervention	Other: Metformin+lifestyle 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); Other Names: group 2

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	up to 8 weeks
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)	up to 8 weeks
Female menstrual pattern	Sex hormones, anti-mullerian hormone (AMH) and 21-day progesterone measurement	up to 8 weeks
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.	up to 8 weeks

Collaborators and Investigators

• Sponsor: RenJi Hospital
• Investigators: Principal Investigator: Tao Tao, MD, RenJi Hospital Department of Endocrinology and Metabolism

Study record dates

Study Major Dates

• Study Start (Estimated): December 20, 2024
• Primary Completion (Estimated): August 1, 2025
• Study Completion (Estimated): June 1, 2026

Study Registration Dates

• First Submitted: November 24, 2024
• First Submitted That Met QC Criteria: November 29, 2024
• First Posted (Estimated): December 4, 2024

Study Record Updates

• Last Update Posted (Estimated): December 4, 2024
• Last Update Submitted That Met QC Criteria: November 29, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Endocrine System Diseases; Pathologic Processes; Nutrition Disorders; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Overnutrition; Body Weight; Disease; Genital Diseases, Female; Ovarian Diseases; Adnexal Diseases; Gonadal Disorders; Ovarian Cysts; Cysts; Overweight; Syndrome; Polycystic Ovary Syndrome; Physiological Effects of Drugs; Hypoglycemic Agents; Metformin
• Other Study ID Numbers: IIT-2023-0156

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No