Clinical trial NCT06717087: Study of Acupuncture to Control Weight and Improve Pregnancy Rates in Overweight/Obese PCOS Patients
Official title: A Randomized Controlled Study of Acupuncture to Control Weight and Improve Pregnancy Rates in Overweight/Obese Polycystic Ovary Syndrome Patients
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Polycystic Ovary Syndrome
Metformin
Acupuncture
Lead sponsor: RenJi Hospital
Sponsor class: OTHER
First posted: 2024-12-04
Enrollment: 92
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: the level of body fat distribution
timeFrame: up to 8 weeks
measure: Pregnancy rates after intervention
timeFrame: up to 1 year
measure: Body mass index
timeFrame: up to 8 weeks
Secondary outcomes:
measure: Standardized TCM syndrome differentiation and classification of PCOS patients
timeFrame: up to 8 weeks
measure: Glucose metabolism
timeFrame: up to 8 weeks
measure: Female menstrual pattern
timeFrame: up to 8 weeks
measure: Intestinal bacteria microbiota
timeFrame: up to 8 weeks
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Renji Hospital, School of Medicine, Shanghai Jiaotong University
Study officials:
affiliation: RenJi Hospital Department of Endocrinology and Metabolism
name: Tao Tao, MD
role: PRINCIPAL_INVESTIGATOR
References: