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NCT07350876
Promotion of a Standardized Diagnostic and Treatment Pathway for Polycystic Ovary Syndrome Based on a Bidirectional Referral System
NA trial testing Standardized Diagnostic and Treatment Pathways for PCOS + Lifestyle Intervention + Prebiotic Supplementation in Polycystic Ovary Syndrome (PCOS) in 227 participants. Completed in 13 December 2025.
13 December 2025
Quick facts
| Lead sponsor | Xuanwu Hospital, Beijing |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 227 |
| Start date | 18 October 2024 |
| Primary completion | 13 December 2025 |
| Estimated completion | 13 December 2025 |
| Sites | 1 location across China |
Drugs / interventions tested
- Standardized Diagnostic and Treatment Pathways for PCOS + Lifestyle Intervention + Prebiotic Supplementation
- Standardized Diagnostic and Treatment Pathways for PCOS + Lifestyle Intervention
Conditions studied
- Polycystic Ovary Syndrome (PCOS) — all drugs for Polycystic Ovary Syndrome (PCOS) →
Sponsor
Xuanwu Hospital, Beijing
Who can join
Adults 18 to 50, female only, with Polycystic Ovary Syndrome (PCOS). Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT07350876
- Europe PMC full search
- ASCO Meeting Library
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Related trials
Other recruiting trials for Polycystic Ovary Syndrome (PCOS)
Currently open trials in the same condition.
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- NCT07371364 — Mobile Application for Women With Polycystic Ovary Syndrome · NA · active not recruiting
- NCT07242131 — Efficacy of Oral Contraceptive, Progesterone, and Inositol on Menstrual Regulation in PCOS · NA · recruiting
- NCT07171970 — IVM - Fresh ET (THE SAIGON PROTOCOL) Versus IVF - FET in PCOS Women · NA · recruiting
Other Xuanwu Hospital, Beijing trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT07350876 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Xuanwu Hospital, Beijing
- Last refreshed: 20 January 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT07350876.
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