Polycystic Ovary Syndrome (PCOS)NCT07350876
Promotion of a Standardized Diagnostic and Treatment Pathway for Polycystic Ovary Syndrome Based on a Bidirectional Referral System
A study testing Standardized Diagnostic and Treatment Pathways for PCOS + Lifestyle Intervention + Prebiotic Supplementation and Standardized Diagnostic and Treatment Pathways for PCOS + Lifestyle Intervention in people with Polycystic Ovary Syndrome (PCOS), run by Xuanwu Hospital, Beijing at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Polycystic Ovary Syndrome (PCOS)
- What is being tested?
- Standardized Diagnostic and Treatment Pathways for PCOS + Lifestyle Intervention + Prebiotic Supplementation and Standardized Diagnostic and Treatment Pathways for PCOS + Lifestyle Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 227 participants
- Where
- 1 siteChina
- Study dates
- 18 Oct 2024to 13 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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:
- promote and optimize standardized diagnostic and treatment pathways for polycystic ovary syndrome (PCOS) and to investigate the clinical phenotypic characteristics of PCOS;
- establish a bidirectional referral system and standardized referral pathways for PCOS;
- comprehensively evaluate the effectiveness of standardized PCOS care pathways based on a bidirectional referral system;
- collaborate with technical partners to develop an information-based clinical management platform for PCOS suitable for use in primary healthcare settings; and
- investigate the effects of combined lifestyle intervention and prebiotic supplementation on insulin resistance and glucose-lipid metabolism in patients with PCOS.
Read more
The main questions this study aims to answer are:
- What are the clinical phenotypic characteristics of PCOS, and how effective are standardized diagnostic and treatment pathways for PCOS?
- 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.
- Conditions
- Polycystic Ovary Syndrome (PCOS)
- Being tested
- Standardized Diagnostic and Treatment Pathways for PCOS + Lifestyle Intervention + Prebiotic Supplementation, Standardized Diagnostic and Treatment Pathways for PCOS + Lifestyle Intervention
- Medical subject headings
- Polycystic Ovary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standardized Diagnostic and Treatment Pathways for PCOS + Lifestyle Intervention + Prebiotic SupplementationDietary 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 Diagnostic and Treatment Pathways for PCOS + Lifestyle InterventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Standardized PCOS Care + Lifestyle Intervention + Prebiotics | Experimental | Not described Receives: Dietary Supplement: Standardized Diagnostic and Treatment Pathways for PCOS + Lifestyle Intervention + Prebiotic Supplementation |
| Standardized PCOS Care + Lifestyle Intervention | Active comparator | Not described Receives: Behavioral: Standardized Diagnostic and Treatment Pathways for PCOS + Lifestyle Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline, Week 12, and Week 20
Secondary outcomes (13)
Weight
Measured: Baseline, Week 12, and Week 20
Body Mass Index
Measured: 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.
Measured: Baseline, Week 12, and Week 20
Waist circumference
Measured: Baseline, Week 12, and Week 20
Waist-to-hip ratio
Measured: Baseline, Week 12, and Week 20
Blood pressure
Measured: Baseline, Week 12, and Week 20
Fasting plasma glucose
Measured: Baseline, Week 12, and Week 20
Fasting insulin
Measured: Baseline, Week 12, and Week 20
Triglycerides
Measured: Baseline, Week 12, and Week 20
Total cholesterol
Measured: Baseline, Week 12, and Week 20
Low-density lipoprotein cholesterol
Measured: Baseline, Week 12, and Week 20
High-density lipoprotein cholesterol
Measured: Baseline, Week 12, and Week 20
Uric acid
Measured: Baseline, Week 12, and Week 20
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2026
- Study start18 Oct 2024
- Primary completion13 Dec 2025
- Study completion13 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Polycystic Ovary Syndrome (PCOS)Studies of the same condition, open and under way.
- More trials run by Xuanwu Hospital, BeijingThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 227 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xuanwu Hospital, Beijing
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shan Gao, Doctoral degree, Study chair, Xuanwu Hospital, Beijing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07350876
- Sponsor's protocol ID
- [2022]214-002
- Status last verified
- Dec 2025
- First submitted
- 30 Dec 2025
- Last updated
- 20 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Promotion of a Standardized Diagnostic and Treatment Pathway for Polycystic Ovary Syndrome in Primary Care Based on a Bidirectional Referral System
- ClinicalTrials.gov ID
- NCT07350876
- Acronym / sponsor ID
- [2022]214-002
- Conditions
- Polycystic Ovary Syndrome (PCOS)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 227 participants (actual)
- Lead sponsor
- Xuanwu Hospital, BeijingUniversity, hospital or other
- Study start
- 18 Oct 2024 (actual)
- Primary completion
- 13 Dec 2025 (actual)
- Study completion
- 13 Dec 2025 (actual)
- First posted
- 20 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to:
- promote and optimize standardized diagnostic and treatment pathways for polycystic ovary syndrome (PCOS) and to investigate the clinical phenotypic characteristics of PCOS;
- establish a bidirectional referral system and standardized referral pathways for PCOS;
- comprehensively evaluate the effectiveness of standardized PCOS care pathways based on a bidirectional referral system;
- collaborate with technical partners to develop an information-based clinical management platform for PCOS suitable for use in primary healthcare settings; and
- 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:
- What are the clinical phenotypic characteristics of PCOS, and how effective are standardized diagnostic and treatment pathways for PCOS?
- 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standardized Diagnostic and Treatment Pathways for PCOS + Lifestyle Intervention + Prebiotic SupplementationParticipants 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. | Dietary supplement | Standardized PCOS Care + Lifestyle Intervention + Prebiotics |
| Standardized Diagnostic and Treatment Pathways for PCOS + Lifestyle InterventionParticipants 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. | Behavioural | Standardized PCOS Care + Lifestyle Intervention |
Primary outcome
Clinical phenotypic characteristics of PCOS assessed by clinical evaluation
Time frame: Baseline, Week 12, and Week 20
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.
Homeostasis Model Assessment of Insulin Resistance (HOMA-IR)
Time frame: Baseline, Week 12, and Week 20
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.
13 secondary outcomes
Weight
Time frame: Baseline, Week 12, and Week 20
Body Mass Index
Time frame: Baseline, Week 12, and Week 20
Menstrual cycle regularity assessed by menstrual cycle length and frequency
Time frame: Baseline, Week 12, and Week 20
Waist circumference
Time frame: Baseline, Week 12, and Week 20
Waist-to-hip ratio
Time frame: Baseline, Week 12, and Week 20
Blood pressure
Time frame: Baseline, Week 12, and Week 20
Fasting plasma glucose
Time frame: Baseline, Week 12, and Week 20
Fasting insulin
Time frame: Baseline, Week 12, and Week 20
Triglycerides
Time frame: Baseline, Week 12, and Week 20
Total cholesterol
Time frame: Baseline, Week 12, and Week 20
Low-density lipoprotein cholesterol
Time frame: Baseline, Week 12, and Week 20
High-density lipoprotein cholesterol
Time frame: Baseline, Week 12, and Week 20
Uric acid
Time frame: Baseline, Week 12, and Week 20
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2026.
- Individual participant dataSharing planned: No. 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.
Related trials for Polycystic Ovary Syndrome (PCOS)
Recruiting
Efficacy of Ovarian Drilling Via vNOTES Laparoscopy in Patients With PCOS
PCOS (Polycystic Ovary Syndrome)
RecruitingPhase 1
Efficacy of Injectable Vitamin D Supplementation in Females With Polycystic Ovary Syndrome
Anovulatory Infertility
RecruitingObservational study
The Value of LC-MS/MS Detection of Androgen Profiles in the Diagnosis of PCOS: A Prospective, Multicenter Real-world Study
Polycystic Ovary Syndrome (PCOS)
Recruiting
The Effects of the Mediterranean Diet and Synbiotics in Polycystic Ovary Syndrome
PCOS (Polycystic Ovary Syndrome)
Recruiting
Brown Adipose Tissue Modulation in Polycystic Ovary Syndrome Using Infrared Thermography
Polycystic Ovary Syndrome (PCOS)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shan Gao, Doctoral degree study chair
Xuanwu Hospital, Beijing
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standardized Diagnostic and Treatment Pathways for PCOS + Lifestyle Intervention + Prebiotic Supplementation and Standardized Diagnostic and Treatment Pathways for PCOS + Lifestyle Intervention in people with Polycystic Ovary Syndrome (PCOS), run by Xuanwu Hospital, Beijing at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical phenotypic characteristics of PCOS assessed by clinical evaluation (time frame: Baseline, Week 12, and Week 20). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2026.