Combined Use of Machine Learning and Metabolomics to Improve the Diagnosis and Management of Hyperandrogenism

NCT07253454 | Not Yet Recruiting

• 1 other identifier: APHP251139
• Study Type: observational
• Target: 800
• Locations: 0 countries
• Sites: N/A

Brief Summary

Hyperandrogenism is a common reason for consultation, the causes of which can range from common conditions (PCOS) to rarer conditions with major genetic implications (NC21OHD). It is characterized by elevated levels of circulating androgens, mainly testosterone. This excess of androgens usually manifests clinically as increased male-pattern hair growth and, less specifically, acne and alopecia. Its prevalence is estimated at between 6 and 12% in women of reproductive age, and its incidence is increasing. It is also responsible for infertility. As a reminder, infertility is a major public health issue and affects more and more couples around the world. The investigators therefore wish to develop innovative tools to improve the diagnosis and management of hyperandrogenism

Conditions

Hyperandrogenism

Keywords

fertility

Outcome Measures

Primary Outcomes (1)

• Use of machine learning models combined with metabolomics to distinguish between different causes of hyperandrogenism

  5 years

Secondary Outcomes (3)

• Use of metabolomics to improve the management of patients with hyperandrogenism

  5 years

• Use of metabolomics to predict CYP21A2 genotyping results

  5 years

• Study of the impact of anti-androgenic hormone therapy on the predictive capabilities of the model

  5 years

Study Arms (1)

principal group

Other: data collection

Interventions

data collection OTHER

collection of data from medical records over a period of 5 years

principal group

Eligibility Criteria

• Age: 16 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

The first stage of the study will involve participating centers selecting patients' medical records after verifying their eligibility. It should be noted that the control group will consist of a population for whom tests were carried out for symptoms that were ultimately ruled out with normal results.

You may qualify if:

• Patients of childbearing age (16 to 45 years old)
• Suffering from hyperandrogenism
• Established etiological diagnosis with elimination of differential diagnoses
• Informed and not opposed to the collection of their data for the purposes of the study

You may not qualify if:

• Pregnancy
• Patients under legal protection measures

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

MeSH Terms

Conditions

Hyperandrogenism

Interventions

Data Collection

Condition Hierarchy (Ancestors)

46, XX Disorders of Sex Development; Disorders of Sex Development; Urogenital Abnormalities; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Adrenogenital Syndrome; Male Urogenital Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Gonadal Disorders; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Central Study Contacts

Anne Pr BACHELOT

CONTACT

0033 01 42 16 02 46; anne.bachelot@aphp.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 19, 2025
• First Posted: November 28, 2025
• Study Start: January 1, 2026
• Primary Completion (Estimated): December 1, 2040
• Study Completion (Estimated): December 1, 2040
• Last Updated: December 4, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Beginning 3 months and ending 3 years following article publication. Requests out of these time frame can also be submitted to the sponsor
• Access Criteria: Researchers who provide a methodologically sound proposal.