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

NCT07350876 | Completed DMC

• 1 other identifier: [2022]214-002
• Study Type: interventional
• Target: 227
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to:

1. 1.promote and optimize standardized diagnostic and treatment pathways for polycystic ovary syndrome (PCOS) and to investigate the clinical phenotypic characteristics of PCOS;
2. 2.establish a bidirectional referral system and standardized referral pathways for PCOS;
3. 3.comprehensively evaluate the effectiveness of standardized PCOS care pathways based on a bidirectional referral system;
4. 4.collaborate with technical partners to develop an information-based clinical management platform for PCOS suitable for use in primary healthcare settings; and
5. 5.investigate the effects of combined lifestyle intervention and prebiotic supplementation on insulin resistance and glucose-lipid metabolism in patients with PCOS.
6. 6.What are the clinical phenotypic characteristics of PCOS, and how effective are standardized diagnostic and treatment pathways for PCOS?
7. 7.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?

Conditions

Polycystic Ovary Syndrome (PCOS)

Outcome Measures

Primary Outcomes (2)

• Clinical phenotypic characteristics of PCOS assessed by clinical evaluation

  1. 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. 2. 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 Outcomes (13)

• 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

  Baseline, Week 12, and Week 20

• Waist circumference

  Baseline, Week 12, and Week 20

• Waist-to-hip ratio

  Baseline, Week 12, and Week 20

Other Outcomes (10)

• Serum estradiol (E2) concentration

  Baseline, Week 12, and Week 20

• Serum progesterone concentration

  Baseline, Week 12, and Week 20

• Serum total testosterone (TT) concentration

  Baseline, Week 12, and Week 20

Study Arms (2)

Standardized PCOS Care + Lifestyle Intervention + Prebiotics

EXPERIMENTAL

Dietary Supplement: Standardized Diagnostic and Treatment Pathways for PCOS + Lifestyle Intervention + Prebiotic Supplementation

Standardized PCOS Care + Lifestyle Intervention

ACTIVE COMPARATOR

Behavioral: Standardized Diagnostic and Treatment Pathways for PCOS + Lifestyle Intervention

Interventions

Standardized Diagnostic and Treatment Pathways for PCOS + Lifestyle Intervention BEHAVIORAL

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.

Standardized PCOS Care + Lifestyle Intervention

Standardized Diagnostic and Treatment Pathways for PCOS + Lifestyle Intervention + Prebiotic Supplementation DIETARY_SUPPLEMENT

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.

Standardized PCOS Care + Lifestyle Intervention + Prebiotics

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Female participants aged 18-50 years.
• 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.

You may not qualify if:

• 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.
• Patients with eating disorders or severe gastrointestinal diseases that may affect nutritional intervention outcomes.
• Patients with any other medical condition associated with an estimated life expectancy of less than 5 years.
• Patients with drug abuse, chronic alcoholism, alcohol dependence, or other addictive tendencies.
• Patients who are unable to comply with dietary modification or lifestyle intervention or who are unlikely to adhere to follow-up visits.
• 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.
• 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.

Sponsors & Collaborators

• Xuanwu Hospital, Beijing: lead

Study Sites (1)

Xuanwu Hospital, Capital Medical University

Beijing, China

Location

MeSH Terms

Conditions

Polycystic Ovary Syndrome

Condition Hierarchy (Ancestors)

Ovarian Cysts; Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases

Study Officials

• Shan Gao, Doctoral degree

  Xuanwu Hospital, Beijing

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 30, 2025
• First Posted: January 20, 2026
• Study Start: October 18, 2024
• Primary Completion: December 13, 2025
• Study Completion: December 13, 2025
• Last Updated: January 20, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)