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Completed

NCT Number: NCT07350876

Promotion of a Standardized Diagnostic and Treatment Pathway for Polycystic Ovary Syndrome 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.

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Key information

Conditions

Polycystic Ovary Syndrome (PCOS) Adnexal Diseases Cysts Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Gonadal Disorders Neoplasms Ovarian Cysts Ovarian Diseases Polycystic Ovary Syndrome Urogenital Diseases

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Xuanwu Hospital, Capital Medical University

Beijing, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

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 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.

Primary outcomes

  1. Clinical phenotypic characteristics of PCOS assessed by clinical evaluation

    Time frame: Baseline, Week 12, and Week 20

    • 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.

  2. 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.

Secondary outcomes

  1. Weight

    Time frame: Baseline, Week 12, and Week 20

  2. Body Mass Index

    Time frame: Baseline, Week 12, and Week 20

  3. Menstrual cycle regularity assessed by menstrual cycle length and frequency

    Time frame: Baseline, Week 12, and Week 20

    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.

  4. Waist circumference

    Time frame: Baseline, Week 12, and Week 20

  5. Waist-to-hip ratio

    Time frame: Baseline, Week 12, and Week 20

  6. Blood pressure

    Time frame: Baseline, Week 12, and Week 20

  7. Fasting plasma glucose

    Time frame: Baseline, Week 12, and Week 20

  8. Fasting insulin

    Time frame: Baseline, Week 12, and Week 20

  9. Triglycerides

    Time frame: Baseline, Week 12, and Week 20

  10. Total cholesterol

    Time frame: Baseline, Week 12, and Week 20

  11. Low-density lipoprotein cholesterol

    Time frame: Baseline, Week 12, and Week 20

  12. High-density lipoprotein cholesterol

    Time frame: Baseline, Week 12, and Week 20

  13. Uric acid

    Time frame: Baseline, Week 12, and Week 20

Other outcomes

  1. Serum estradiol (E2) concentration

    Time frame: Baseline, Week 12, and Week 20

    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.

  2. Serum progesterone concentration

    Time frame: Baseline, Week 12, and Week 20

    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.

  3. Serum total testosterone (TT) concentration

    Time frame: Baseline, Week 12, and Week 20

    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.

  4. Serum luteinizing hormone (LH) concentration

    Time frame: Baseline, Week 12, and Week 20

    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.

  5. Serum follicle-stimulating hormone (FSH) concentration

    Time frame: Baseline, Week 12, and Week 20

    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.

  6. Serum anti-Müllerian hormone (AMH) concentration

    Time frame: Baseline, Week 12, and Week 20

    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.

  7. Gut microbiota composition assessed by 16S rRNA gene sequencing

    Time frame: Baseline and Week 20

    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.

  8. Circulating adipokines assessed by serum analysis

    Time frame: Baseline, Week 12, and Week 20

    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.

  9. Serum proteomic profile assessed by liquid chromatography-tandem mass spectrometry (LC-MS/MS)

    Time frame: Baseline, Week 12, and Week 20

    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.

  10. Serum metabolomic profile assessed by liquid chromatography-tandem mass spectrometry (LC-MS/MS)

    Time frame: Baseline, Week 12, and Week 20

    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.

Sponsors and collaborators

Lead sponsor

Xuanwu Hospital, Beijing

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jan 20, 2026
Registry last updated
Jan 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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