The Value of LC-MS/MS Detection of Androgen Profiles in the Diagnosis of PCOS: A Prospective, Multicenter Real-world Study
NCT07916909, Recruiting, Women's Hospital School Of Medicine Zhejiang University
Trial 9
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | The Value of LC-MS/MS Detection of Androgen Profiles in the Diagnosis of PCOS: A Prospective, Multicenter Real-world Study | ClinicalTrials.gov |
| NCT number | NCT07916909 | ClinicalTrials.gov |
| Status | Recruiting | ClinicalTrials.gov |
| Enrollment | 1,500 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Women's Hospital School Of Medicine Zhejiang University | ClinicalTrials.gov |
| Conditions | Polycystic Ovary Syndrome (PCOS) | ClinicalTrials.gov |
| Interventions | No Intervention: Observational Cohort, No Intervention: Observational Cohort, No Intervention: Observational Cohort | ClinicalTrials.gov |
| First posted | 2026-11-04 | ClinicalTrials.gov |
| Last updated | 2026-11-04 | ClinicalTrials.gov |
Registered outcomes 2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Area Under the ROC Curve (AUC) of LC-MS/MS-derived Androgen Profiles for the Diagnosis of Polycystic Ovary Syndrome (PCOS) | Measured at baseline (at the time of study enrollment) | The diagnostic accuracy of a panel of androgen profiles measured by liquid chromatography-tandem mass spectrometry (LC-MS/MS) will be evaluated. The reference standard for PCOS diagnosis is based on the Rotterdam criteria, which require at least two of the following three features after excluding other endocrine disorders: 1) oligo-ovulation or anovulation, 2) clinical and/or biochemical hyperandrogenism, and 3) polycystic ovarian morphology on ultrasound. The primary analysis will calculate the Area Under the Receiver Operating Characteristic Curve (AUC-ROC). Sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), and optimal cut-off values for specific androgens determined by the Youden index will also be reported. A higher AUC indicates better discriminative ability for distinguishing PCOS from non-PCOS controls. | ClinicalTrials.gov |
| Primary | Area Under the ROC Curve (AUC) of LC-MS/MS-derived Androgen Profiles for the Diagnosis of Polycystic Ovary Syndrome (PCOS) | Measured at baseline (at the time of study enrollment) | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
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Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
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Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
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Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
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Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
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Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
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Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
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Tests 0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
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Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)