Observational Study on the Causal Architecture of Polycystic Ovary Syndrome (PCOS)

May 28, 2026 updated by: AnnieGuard Corp.

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

Women aged 18 to 45 who have been diagnosed with Polycystic Ovary Syndrome (PCOS) by a licensed healthcare provider. Participants are recruited globally with no geographic restriction. All participants must have a confirmed diagnosis and be willing to voluntarily submit existing lab results and clinical history.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Other: No intervention - observational data collection only
This is an observational study. No intervention or treatment is administered. Participants submit existing lab results and clinical history through an online questionnaire.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Computational Reconstruction of the Causal Architecture of PCOS
Time Frame: 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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Identification of Architectural Patterns Across PCOS Cohort
Time Frame: 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
Time Frame: 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AnnieGuard Corp.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

July 1, 2026

Study Registration Dates

First Submitted

May 28, 2026

First Submitted That Met QC Criteria

May 28, 2026

First Posted (Actual)

June 3, 2026

Study Record Updates

Last Update Posted (Actual)

June 3, 2026

Last Update Submitted That Met QC Criteria

May 28, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AG-PCOS-2026-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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