- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT07623551
Observational Study on the Causal Architecture of Polycystic Ovary Syndrome (PCOS)
An Observational Data Collection Study to Characterize the Hormonal, Metabolic, and Clinical Architecture of Polycystic Ovary Syndrome in Women Aged 18 to 45: A Global Recruitment Initiative
The goal of this observational study is to learn about the causal architecture of Polycystic Ovary Syndrome (PCOS) in women aged 18 to 45. The main questions it aims to answer are:
What does the hormonal, metabolic, and clinical architecture of PCOS look like across a diverse global population? Can the causal architecture of PCOS be reconstructed from existing lab results and clinical data? Are there distinct architectural patterns across different groups of women with PCOS? Participants who have been diagnosed with PCOS by a healthcare provider will complete an online questionnaire about their diagnosis, symptoms, clinical history, current treatment, and existing lab results. Participants will also be asked to submit copies of their most recent blood work and lab results. No intervention or treatment is involved. All data is de-identified.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
Polycystic Ovary Syndrome (PCOS) affects approximately 1 in 10 women of reproductive age worldwide. Despite its prevalence, the causal architecture of PCOS remains poorly characterized. Current treatment approaches focus on symptom management rather than addressing underlying biological structure.
This study takes a different approach. Using a computational methodology called Biology First Intelligence, developed by AnnieGuard, the study aims to reconstruct the causal architecture of PCOS from participant-submitted clinical data. Rather than predicting outcomes from statistical correlations, the methodology maps how the condition is structurally built at the biological level, with the goal of identifying architectural patterns that may inform future treatment strategies.
The study collects data across six clinical domains: androgen profile (total testosterone, free testosterone, DHEA-S, androstenedione, SHBG), reproductive hormones (LH, FSH, AMH, estradiol, progesterone, prolactin), metabolic markers (fasting insulin, fasting glucose, HbA1c, HOMA-IR), thyroid function (TSH, free T4, free T3, TPO antibodies), lipid profile (total cholesterol, HDL, LDL, triglycerides), and inflammatory and nutritional markers (vitamin D, ferritin, B12, CRP, cortisol, 17-hydroxyprogesterone).
Participants complete a structured online questionnaire covering demographics, diagnosis history, Rotterdam criteria, current symptoms, comorbidities, family history, current medications, dietary approach, exercise habits, and self-reported lab values. Participants are also asked to submit copies of their lab results directly to the research team for verification.
The study recruits globally with no geographic restriction. Eligibility requires a confirmed PCOS diagnosis from a licensed healthcare provider, age 18 to 45, and willingness to share clinical data voluntarily.
The primary outcome is the computational reconstruction of the causal architecture of PCOS across the study cohort. Secondary outcomes include identification of cohort-level architectural patterns, characterization of PCOS subtypes based on biological architecture, and assessment of the relationship between current treatment approaches and underlying causal structure.
Studietyp
Inskrivning (Beräknad)
Kontakter och platser
Studiekontakt
- Namn: Tiara Principal Investigator
- Telefonnummer: 240-234-0449
- E-post: info@annieguard.com
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
Tar emot friska volontärer
Testmetod
Studera befolkning
Beskrivning
Inclusion Criteria:
- Female
- Aged 18 to 45 years
- Diagnosed with Polycystic Ovary Syndrome (PCOS) by a licensed healthcare provider
- Willing to voluntarily share existing lab results and clinical history
- Able to provide informed consent
Exclusion Criteria:
- Under 18 years of age
- Over 45 years of age
- No confirmed PCOS diagnosis from a licensed healthcare provider
- Unable or unwilling to provide informed consent
Studieplan
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
Intervention / Behandling |
|---|---|
|
PCOS Cohort
Women aged 18 to 45 diagnosed with Polycystic Ovary Syndrome (PCOS) by a licensed healthcare provider.
Participants complete an online questionnaire covering diagnosis history, symptoms, comorbidities, family history, current treatment, and self-reported lab values.
Participants also submit copies of their lab results for verification.
No intervention is administered.
|
This is an observational study.
No intervention or treatment is administered.
Participants submit existing lab results and clinical history through an online questionnaire.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Computational Reconstruction of the Causal Architecture of PCOS
Tidsram: Upon completion of data collection, approximately 2 months from study start
|
Reconstruction of the hormonal, metabolic, and clinical architecture of Polycystic Ovary Syndrome across the study cohort using computational analysis of participant-submitted lab results and clinical data.
|
Upon completion of data collection, approximately 2 months from study start
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Identification of Architectural Patterns Across PCOS Cohort
Tidsram: Upon completion of data analysis, approximately 2 months from study start
|
Identification and characterization of distinct architectural patterns across participant cohorts based on hormonal, metabolic, thyroid, lipid, and inflammatory marker profiles.
|
Upon completion of data analysis, approximately 2 months from study start
|
|
Assessment of Current Treatment Approaches Relative to Causal Architecture
Tidsram: Upon completion of data analysis, approximately 2 months from study start
|
Evaluation of the relationship between participants' current treatment approaches and the underlying causal architecture identified through computational reconstruction.
|
Upon completion of data analysis, approximately 2 months from study start
|
Samarbetspartners och utredare
Sponsor
Studieavstämningsdatum
Studera stora datum
Studiestart (Beräknad)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
- Urogenitala sjukdomar
- Genitala sjukdomar
- Sjukdomar i det endokrina systemet
- Neoplasmer
- Kvinnliga urogenitala sjukdomar
- Kvinnliga urogenitala sjukdomar och graviditetskomplikationer
- Genitala sjukdomar, kvinnor
- Ovariella sjukdomar
- Adnexala sjukdomar
- Gonadal sjukdomar
- Cystor på äggstockarna
- Cystor
- Polycystiskt ovariesyndrom
Andra studie-ID-nummer
- AG-PCOS-2026-001
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
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