Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acupuncture | — | UNRESOLVED | — |
| Metformin | — | UNRESOLVED | — |
| Polycystic Ovary Syndrome | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Acupuncture+lifestyle intervention | Other | — | UNRESOLVED |
| Metformin+lifestyle intervention | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- acupuncture+ intensive lifestyle intervention
- description
- 8 weeks acupuncture+ intensive lifestyle intervention
- interventionNames
- Other: Acupuncture+lifestyle intervention
- type
- ACTIVE_COMPARATOR
- label
- metformin + intensive lifestyle intervention
- description
- 8 weeks metformin treatment(metformin 500 mg three times a day with meals)+ intensive lifestyle intervention
- interventionNames
- Other: Metformin+lifestyle intervention
Primary outcomes (3)
- measure
- the level of body fat distribution
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 40 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available