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

NCT07623551 | Not Yet Recruiting

• 1 other identifier: AG-PCOS-2026-001
• Study Type: observational
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Polycystic Ovary Syndrome; Polycystic Ovary Syndrome (PCOS); PCOS; PCOS (Polycystic Ovary Syndrome)

Keywords

PCOS; Polycystic Ovary Syndrome; Women's Health; Endocrine; Hormonal; Metabolic; Observational Study; Causal Architecture

Outcome Measures

Primary Outcomes (1)

• Computational Reconstruction of the Causal Architecture of PCOS

  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 Outcomes (2)

• Identification of Architectural Patterns Across PCOS Cohort

  Upon completion of data analysis, approximately 2 months from study start

• Assessment of Current Treatment Approaches Relative to Causal Architecture

  Upon completion of data analysis, approximately 2 months from study start

Study Arms (1)

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

Interventions

No intervention - observational data collection only OTHER

This is an observational study. No intervention or treatment is administered. Participants submit existing lab results and clinical history through an online questionnaire.

PCOS Cohort

Eligibility Criteria

• Age: 18 Years - 45 Years
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• AnnieGuard Corp.: lead

MeSH Terms

Conditions

Polycystic Ovary Syndrome

Condition Hierarchy (Ancestors)

Ovarian Cysts; Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases

Central Study Contacts

Tiara Principal Investigator

CONTACT

240-234-0449; info@annieguard.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 28, 2026
• First Posted: June 3, 2026
• Study Start: June 1, 2026
• Primary Completion: July 1, 2026
• Study Completion: July 1, 2026
• Last Updated: June 3, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share