Polycystic Ovary SyndromeNCT07623551
Observational Study on the Causal Architecture of Polycystic Ovary Syndrome (PCOS)
An observational study of Polycystic Ovary Syndrome and Polycystic Ovary Syndrome (PCOS), run by AnnieGuard Corp..
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Polycystic Ovary Syndrome, Polycystic Ovary Syndrome (PCOS), PCOS
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Jun 2026to Jul 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
Read the 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.
- Conditions
- Polycystic Ovary Syndrome, Polycystic Ovary Syndrome (PCOS), PCOS, PCOS (Polycystic Ovary Syndrome)
- Being tested
- No intervention - observational data collection only
- Keywords
- PCOS, Polycystic Ovary Syndrome, Women's Health, Endocrine, Hormonal, Metabolic, Observational Study, Causal Architecture
- Medical subject headings
- Polycystic Ovary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No intervention - observational data collection onlyOther
This is an observational study. No intervention or treatment is administered. Participants submit existing lab results and clinical history through an online questionnaire.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: No intervention - observational data collection only |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Upon completion of data collection, approximately 2 months from study start
Secondary outcomes (2)
Identification of Architectural Patterns Across PCOS Cohort
Identification and characterization of distinct architectural patterns across participant cohorts based on hormonal, metabolic, thyroid, lipid, and inflammatory marker profiles.
Measured: Upon completion of data analysis, approximately 2 months from study start
Assessment of Current Treatment Approaches Relative to Causal Architecture
Evaluation of the relationship between participants' current treatment approaches and the underlying causal architecture identified through computational reconstruction.
Measured: Upon completion of data analysis, approximately 2 months from study start
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2026
- Study startJun 2026 (estimated)
- Primary completionJul 2026 (estimated)
- Study completionJul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Polycystic Ovary SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AnnieGuard Corp.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07623551
- Sponsor's protocol ID
- AG-PCOS-2026-001
- Status last verified
- May 2026
- First submitted
- 28 May 2026
- Last updated
- 3 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07623551
- Acronym / sponsor ID
- AG-PCOS-2026-001
- 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
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- AnnieGuard Corp.Industry (pharma, biotech, devices)
- Study start
- Jun 2026 (estimated)
- Primary completion
- Jul 2026 (estimated)
- Study completion
- Jul 2026 (estimated)
- First posted
- 3 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PCOS Cohort | – | Other: No intervention - observational data collection onlyWomen 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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Age groups
- Adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No intervention - observational data collection onlyThis is an observational study. No intervention or treatment is administered. Participants submit existing lab results and clinical history through an online questionnaire. | Other | PCOS Cohort |
Primary outcome
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.
2 secondary outcomes
Identification of Architectural Patterns Across PCOS Cohort
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
An observational study of Polycystic Ovary Syndrome and Polycystic Ovary Syndrome (PCOS), run by AnnieGuard Corp..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 3 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tiara Principal Investigator (240-234-0449, info@annieguard.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Computational Reconstruction of the Causal Architecture of PCOS (time frame: Upon completion of data collection, approximately 2 months from study start). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2026.