Promotion of a Standardized Diagnostic and Treatment Pathway for Polycystic Ovary Syndrome Based on a Bidirectional Referral System

Promotion of a Standardized Diagnostic and Treatment Pathway for Polycystic Ovary Syndrome in Primary Care Based on a Bidirectional Referral System

The goal of this clinical trial is to:

1. promote and optimize standardized diagnostic and treatment pathways for polycystic ovary syndrome (PCOS) and to investigate the clinical phenotypic characteristics of PCOS;
2. establish a bidirectional referral system and standardized referral pathways for PCOS;
3. comprehensively evaluate the effectiveness of standardized PCOS care pathways based on a bidirectional referral system;
4. collaborate with technical partners to develop an information-based clinical management platform for PCOS suitable for use in primary healthcare settings; and
5. investigate the effects of combined lifestyle intervention and prebiotic supplementation on insulin resistance and glucose-lipid metabolism in patients with PCOS.

The main questions this study aims to answer are:

1. What are the clinical phenotypic characteristics of PCOS, and how effective are standardized diagnostic and treatment pathways for PCOS?
2. What are the effects of combined lifestyle intervention and prebiotic supplementation, implemented within standardized diagnostic and treatment pathways for PCOS, on insulin resistance and glucose-lipid metabolism in patients with PCOS?

Researchers will compare standardized diagnostic and treatment pathways for PCOS before and after implementation to assess improvements in clinical outcomes in patients with PCOS, and will also compare lifestyle intervention with and without prebiotic supplementation to determine whether prebiotic supplementation can improve insulin resistance and glucos-lipid metabolism in patients with PCOS.

All participants will first undergo a 12-week run-in phase, during which standardized diagnostic and treatment pathways for PCOS combined with lifestyle intervention will be implemented uniformly. After completion of the run-in phase and randomization at Week 12, participants will be assigned to one of two parallel intervention arms. Participants in the control arm will continue to receive lifestyle intervention alone for an additional 8 weeks, without additional prebiotic supplementation. Participants in the intervention arm will continue to receive lifestyle intervention and will additionally receive prebiotic supplementation for 8 weeks.

Study Overview

• Status: Completed
• Conditions: Polycystic Ovary Syndrome (PCOS)
• Intervention / Treatment: Dietary supplement: Standardized Diagnostic and Treatment Pathways for PCOS + Lifestyle Intervention + Prebiotic Supplementation; Behavioral: Standardized Diagnostic and Treatment Pathways for PCOS + Lifestyle Intervention

• Study Type: Interventional
• Enrollment (Actual): 227
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing, China
    • Xuanwu Hospital, Capital Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Female participants aged 18-50 years.
2. A diagnosis of PCOS based on the 2003 Rotterdam consensus, meeting at least two of the following three criteria: (i) oligo-ovulation and/or anovulation;(ii) clinical and/or biochemical signs of hyperandrogenism; or(iii) polycystic ovarian morphology on ultrasonography, defined as the presence of ≥12 follicles measuring 2-9 mm in diameter in each ovary and/or an ovarian volume ≥10 cm³.

Exclusion Criteria:

1. Patients with other serious medical conditions, including coronary heart disease (e.g., angina pectoris, myocardial infarction, history of coronary revascularization, or abnormal Q waves on electrocardiography), stroke (ischemic or hemorrhagic, including transient ischemic attack), or severe hepatic or renal dysfunction.
2. Patients with eating disorders or severe gastrointestinal diseases that may affect nutritional intervention outcomes.
3. Patients with any other medical condition associated with an estimated life expectancy of less than 5 years.
4. Patients with drug abuse, chronic alcoholism, alcohol dependence, or other addictive tendencies.
5. Patients who are unable to comply with dietary modification or lifestyle intervention or who are unlikely to adhere to follow-up visits.
6. Pregnant or lactating women, or those who have used oral contraceptives or glucagon-like peptide-1 (GLP-1) receptor agonists within the past 3 months.
7. Patients with a known allergy to prebiotics, those who have taken probiotics, prebiotics, or synbiotic supplements within the past 3 months, or those who have used antibiotics within the past 1 month.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Standardized PCOS Care + Lifestyle Intervention + Prebiotics	Dietary supplement: Standardized Diagnostic and Treatment Pathways for PCOS + Lifestyle Intervention + Prebiotic Supplementation; Participants will first undergo the same 12-week run-in phase as the control arm, during which standardized diagnostic and treatment pathways for PCOS combined with lifestyle intervention will be implemented uniformly. After completion of the run-in phase and randomization at Week 12, participants in the intervention arm will continue to receive lifestyle intervention and will additionally receive prebiotic supplementation for 8 weeks.
Active Comparator: Standardized PCOS Care + Lifestyle Intervention	Behavioral: Standardized Diagnostic and Treatment Pathways for PCOS + Lifestyle Intervention; Participants will first undergo a 12-week run-in phase, during which standardized diagnostic and treatment pathways for PCOS combined with lifestyle intervention will be implemented uniformly. After completion of the run-in phase and randomization at Week 12, participants in the control arm will continue to receive lifestyle intervention alone for an additional 8 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical phenotypic characteristics of PCOS assessed by clinical evaluation	Improvement in PCOS clinical phenotypes based on the Rotterdam criteria Improvement in PCOS clinical phenotypes will be assessed by trained study investigators based on changes in clinical manifestations, including menstrual cycle regularity, clinical hyperandrogenism, and gynecological ultrasound findings. Overall improvement will be evaluated based on changes in phenotype-specific clinical characteristics according to the Rotterdam criteria.; Improvement in obesity-related metabolic phenotypes Improvement in obesity-related metabolic phenotypes will be assessed by trained study investigators based on changes in body weight status and metabolic health. Metabolic abnormality is defined as the presence of hypertension, impaired glucose metabolism, or dyslipidemia. Overall improvement will be evaluated based on changes in phenotype-specific characteristics related to body weight status and metabolic health.	Baseline, Week 12, and Week 20
Homeostasis Model Assessment of Insulin Resistance (HOMA-IR)	Insulin resistance will be assessed using the HOMA-IR, calculated from fasting plasma glucose and fasting insulin levels measured at predefined study time points. Outcomes will include HOMA-IR values reported as continuous variables and comparisons of changes in HOMA-IR between baseline and post-intervention time points and/or between intervention groups.	Baseline, Week 12, and Week 20

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Weight		Baseline, Week 12, and Week 20
Body Mass Index		Baseline, Week 12, and Week 20
Menstrual cycle regularity assessed by menstrual cycle length and frequency	Menstrual cycle regularity will be assessed by the study investigators based on menstrual cycle length and cycle frequency, obtained from patient-reported menstrual history during study visits. Menstrual irregularity is defined as a menstrual cycle length <21 or >35 days, or fewer than 8 menstrual cycles per year.	Baseline, Week 12, and Week 20
Waist circumference		Baseline, Week 12, and Week 20
Waist-to-hip ratio		Baseline, Week 12, and Week 20
Blood pressure		Baseline, Week 12, and Week 20
Fasting plasma glucose		Baseline, Week 12, and Week 20
Fasting insulin		Baseline, Week 12, and Week 20
Triglycerides		Baseline, Week 12, and Week 20
Total cholesterol		Baseline, Week 12, and Week 20
Low-density lipoprotein cholesterol		Baseline, Week 12, and Week 20
High-density lipoprotein cholesterol		Baseline, Week 12, and Week 20
Uric acid		Baseline, Week 12, and Week 20

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Serum estradiol (E2) concentration	Serum E2 concentrations will be measured in fasting serum samples collected at predefined study time points using standardized laboratory procedures. Outcomes will be reported as continuous variables, and changes in estradiol concentrations will be compared between baseline and post-intervention time points and/or between intervention groups.	Baseline, Week 12, and Week 20
Serum progesterone concentration	Serum progesterone concentrations will be measured in fasting serum samples collected at predefined study time points using standardized laboratory procedures. Outcomes will be reported as continuous variables, and changes in progesterone concentrations will be compared between baseline and post-intervention time points and/or between intervention groups.	Baseline, Week 12, and Week 20
Serum total testosterone (TT) concentration	Serum TT concentrations will be measured in fasting serum samples collected at predefined study time points using standardized laboratory procedures. Outcomes will be reported as continuous variables, and changes in total testosterone concentrations will be compared between baseline and post-intervention time points and/or between intervention groups.	Baseline, Week 12, and Week 20
Serum luteinizing hormone (LH) concentration	LH concentrations will be measured in fasting serum samples collected at predefined study time points using standardized laboratory procedures. Outcomes will be reported as continuous variables, and changes in LH concentrations will be compared between baseline and post-intervention time points and/or between intervention groups.	Baseline, Week 12, and Week 20
Serum follicle-stimulating hormone (FSH) concentration	Serum FSH concentrations will be measured in fasting serum samples collected at predefined study time points using standardized laboratory procedures. Outcomes will be reported as continuous variables, and changes in FSH concentrations will be compared between baseline and post-intervention time points and/or between intervention groups.	Baseline, Week 12, and Week 20
Serum anti-Müllerian hormone (AMH) concentration	Serum anti-Müllerian hormone (AMH) concentrations will be measured in fasting serum samples collected at predefined study time points using standardized laboratory procedures. This outcome will be evaluated by trained study investigators.	Baseline, Week 12, and Week 20
Gut microbiota composition assessed by 16S rRNA gene sequencing	Gut microbiota profiling will be conducted on fecal samples collected at predefined study time points using 16S rRNA gene sequencing. Outcomes will include measures of gut microbial diversity, relative abundances of bacterial taxa, and the identification of taxa showing significant changes between baseline and post-intervention time points and/or between intervention groups. These outcomes are intended to characterize intervention-associated alterations in gut microbiota composition.	Baseline and Week 20
Circulating adipokines assessed by serum analysis	Adipokine profiling will be conducted on fasting serum samples collected at predefined study time points. Outcomes will include circulating concentrations of selected adipokines and the identification of adipokines showing significant changes between baseline and post-intervention time points and/or between intervention groups, reflecting alterations in adipose tissue-related endocrine function associated with the intervention.	Baseline, Week 12, and Week 20
Serum proteomic profile assessed by liquid chromatography-tandem mass spectrometry (LC-MS/MS)	Proteomic profiling will be conducted on fasting serum samples collected at predefined study time points using LC-MS/MS. Primary proteomic outcomes will include relative protein abundances quantified based on normalized signal intensities and the identification of proteins showing significant differential expression between baseline and post-intervention time points and/or between intervention groups, reflecting molecular alterations associated with the intervention.	Baseline, Week 12, and Week 20
Serum metabolomic profile assessed by liquid chromatography-tandem mass spectrometry (LC-MS/MS)	Metabolomic profiling will be conducted on fasting serum samples collected at predefined study time points using LC-MS/MS. Metabolomic outcomes will include relative abundances of detected metabolites quantified based on normalized signal intensities, as well as the identification of metabolites showing significant changes between baseline and post-intervention time points and/or between intervention groups, reflecting metabolic responses to the intervention.	Baseline, Week 12, and Week 20

Collaborators and Investigators

• Sponsor: Xuanwu Hospital, Beijing
• Investigators: Study Chair: Shan Gao, Doctoral degree, Xuanwu Hospital, Beijing

Study record dates

Study Major Dates

• Study Start (Actual): October 18, 2024
• Primary Completion (Actual): December 13, 2025
• Study Completion (Actual): December 13, 2025

Study Registration Dates

• First Submitted: December 30, 2025
• First Submitted That Met QC Criteria: January 9, 2026
• First Posted (Actual): January 20, 2026

Study Record Updates

• Last Update Posted (Actual): January 20, 2026
• Last Update Submitted That Met QC Criteria: January 9, 2026
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Endocrine System Diseases; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Genital Diseases, Female; Ovarian Diseases; Adnexal Diseases; Gonadal Disorders; Ovarian Cysts; Cysts; Polycystic Ovary Syndrome
• Other Study ID Numbers: [2022]214-002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data will not be shared due to concerns regarding participant privacy and confidentiality, and because no formal plan for external data sharing has been established at this time.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No