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

Launched by RENJI HOSPITAL · Nov 29, 2024

Keywords

ClinConnect Summary

This clinical trial is studying how effective acupuncture is for helping overweight or obese women with Polycystic Ovary Syndrome (PCOS) in losing weight and improving their chances of getting pregnant. PCOS is a common condition that can cause irregular periods and fertility issues due to hormonal imbalances. The trial will compare the effects of acupuncture and a medication called metformin, both combined with a supportive lifestyle change program, to see which one works better for these patients.

To be eligible for this study, participants must be women aged 20 to 40 who are diagnosed with PCOS and have a body mass index (BMI) between 25 and 40, which indicates they are overweight or obese. Participants should be willing to sign a consent form to join the trial. Those with certain health conditions, such as severe heart disease or kidney problems, or recent use of specific medications, will not be able to participate. If someone joins the trial, they can expect to receive treatment, support for lifestyle changes, and regular follow-ups throughout the study. This could be a valuable opportunity for women struggling with PCOS to explore new options for improving their health and fertility.

Gender

FEMALE

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.