NCT06717087

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 92 (estimated)
• Sponsor: RenJi Hospital · Academic / Other
• Sex: Female
• Age: 18 Years – 40 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Polycystic Ovary Syndrome
• Metformin
• Acupuncture

Interventions

Type	Name	Description
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	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)

Timeline

• Start date: 2024-12-20
• Primary completion: 2025-08-01
• Completion: 2026-06-01
• First posted: 2024-12-04
• Last updated: 2024-12-04

Locations

1 site across 1 country: China