NCT05386706

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 18, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 23, 2022

Completed
29 days until next milestone

Study Start

First participant enrolled

June 21, 2022

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 12, 2023

Completed
20 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2023

Completed
Last Updated

November 13, 2023

Status Verified

November 1, 2023

Enrollment Period

1.1 years

First QC Date

May 18, 2022

Last Update Submit

November 8, 2023

Conditions

Polycystic Ovary Syndrome

Outcome Measures

Primary Outcomes (1)

  • Homeostasis model assessment of insulin resistance

    insulin resistance index

    3 months

Secondary Outcomes (17)

  • Anthropometry

    3 months

  • menstrual frequency

    3 months

  • fasting glucose

    3 months

  • fasting insulin

    3 months

  • Total cholesterol

    3 months

  • +12 more secondary outcomes

Study Arms (2)

Digital Intervention

EXPERIMENTAL

A mini program-based digital intervention.

Behavioral: Digital Intervention

Metformin

ACTIVE COMPARATOR

Traditional metformin monotherapy.

Drug: Metformin

Interventions

Digital InterventionBEHAVIORAL

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

Digital Intervention
MetforminDRUG

Traditional metformin monotherapy.

Also known as: Metformin treatment
Metformin

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Endocrinology, Shanghai Tenth People's Hospital

Shanghai, Shanghai Municipality, 200070, China

Location

Related Publications (1)

  • Dilimulati D, Shao X, Wang L, Cai M, Zhang Y, Lu J, Wang Y, Liu H, Kuang M, Chen H, Zhang M, Qu S. Efficacy of WeChat-Based Digital Intervention Versus Metformin in Women With Polycystic Ovary Syndrome: Randomized Controlled Trial. J Med Internet Res. 2024 Oct 2;26:e55883. doi: 10.2196/55883.

    PMID: 39357046DERIVED

MeSH Terms

Conditions

Polycystic Ovary Syndrome

Interventions

Metformin

Condition Hierarchy (Ancestors)

Ovarian CystsCystsNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesGonadal DisordersEndocrine System Diseases

Intervention Hierarchy (Ancestors)

BiguanidesGuanidinesAmidinesOrganic Chemicals

Study Officials

  • Shen Qu, Doctor

    Shanghai 10th People's Hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, Principal Investigator, Clinical Professor

Study Record Dates

First Submitted

May 18, 2022

First Posted

May 23, 2022

Study Start

June 21, 2022

Primary Completion

August 12, 2023

Study Completion

September 1, 2023

Last Updated

November 13, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)