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Compares acupuncture and metformin for weight and pregnancy in PCOS

Compares acupuncture with metformin, plus lifestyle changes, in overweight women with PCOS.

Plain-language title generated from the registry record
Registry title: Study of Acupuncture to Control Weight and Improve Pregnancy Rates in Overweight/Obese PCOS Patients

Key facts

Where
Shanghai, ChinaSee the site

AI summary: who the study is looking for

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for women aged 20 to 40 with polycystic ovary syndrome (PCOS) who are overweight or obese. It compares acupuncture and metformin, each with lifestyle changes.

Age
20 to 40 years old (the registry header lists a minimum age of 18 years).
Sex
Women only.
Disease stage
PCOS diagnosed by the 2003 Rotterdam criteria, with at least two of three signs: high androgen signs, irregular or missing periods, or polycystic ovaries. BMI from 25 to 40 kg/m2.
Earlier treatment
No acupuncture within 2 months. No hormonal drugs, antidepressants, other diabetes drugs, contraceptives or ovulation induction drugs within 12 weeks.
Biomarker or test result
High androgen can mean total testosterone above 2.6 nmol/L or free androgen index above 7. Atypical congenital adrenal hyperplasia, androgen-secreting tumors and suspected Cushing syndrome are ruled out.

Main reasons for not taking part

  • Severe heart disease or blood disease
  • Kidney disease, high liver tests, autoimmune disease or cancer
  • Type I diabetes
  • Allergy to metformin hydrochloride or its other ingredients
  • Pregnancy or breastfeeding in the past three months

Read by machine on 12 November 2026.

Could this be for you?

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 18 and 40 years old?

Source: NCT06717087, who can take part

Where in China

  • Renji Hospital, School of Medicine, Shanghai Jiaotong UniversityShanghai, ChinaContact: Tao Tao, MDNo longer taking part

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

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Trial details

Who runs it
RenJi Hospital
Trial code
NCT06717087
Record updated
4 December 2024
Original description
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.Read full original descriptionShow less

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.

Inclusion: 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.

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

ClinicalTrials.gov NCT06717087