NCT07350876Completed
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
Source: ClinicalTrials.gov · Last updated 20 Jan 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 227 (actual)
- First submitted
- 30 Dec 2025
- Start date
- 18 Oct 2024
- Primary completion date
- 13 Dec 2025
- Lead sponsor
- Xuanwu Hospital, Beijing
- NCT number
- NCT07350876
What you commit to
- Study type: Interventional
- Participants enrolled: 227
- From 18 Oct 2024 to the primary completion date, 13 Dec 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients with drug abuse, chronic alcoholism, alcohol dependence, or other addictive tendencies.
Other illness
- 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 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.
Other
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to 50 years · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Xuanwu Hospital, Capital Medical University Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.