Treating PCOS With Digital Intervention vs. Metformin

Tongji University

Status: Completed

Conditions: Polycystic Ovary Syndrome

Treatments: Drug: Metformin; Behavioral: Digital Intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT05386706

Digital Intervention PCOS

Details and patient eligibility

About

With the change in environment and lifestyle, and the improvement of people's understanding of PCOS, the incidence of PCOS is increasing worldwide. According to statistics, the prevalence of PCOS in premenopausal women is as high as 5-20%. Lifestyle interventions are the main treatment option for patients with PCOS. In addition, research has shown that digital therapy can effectively improve behavior changes in diet, exercise, and medication adherence, predict disease progression, reduce the frequency of disease-related symptoms, and promote effective disease management. This study aimed to investigate the efficacy of digital intervention versus traditional metformin monotherapy in patients with PCOS.

Full description

This study developed a mini-program that combined diet, exercise, sleep, and mood interventions for PCOS women.

Enrollment: 80 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Female aged 18- 45; Meet Rotterdam criteria; Insulin Resistance

Exclusion criteria

Women who are pregnant or have a pregnancy plan within six months; Congenital adrenocortical hyperplasia; Hyperprolactinemia; Hyperthyroidism or hypothyroidism; Abnormal liver function (≥ 3 times the upper limit of the normal range); Abnormal renal function (GFR<60ml/min/1.73m2); Adrenal or ovarian tumors secreting androgens; Used contraceptives, metformin, pioglitazone, and antidepressant medication in the last 3 months.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 2 patient groups

Digital Intervention

Experimental group

Description:

A mini program-based digital intervention.

Treatment:

Behavioral: Digital Intervention

Metformin

Active Comparator group

Description:

Traditional metformin monotherapy.

Treatment:

Drug: Metformin