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

NCT ID: NCT07253454

Last Updated: 2025-12-04

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 800 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2026-01-31
• Study Completion Date: 2040-12-31

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

Detailed Description

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

principal group

data collection

Intervention Type: OTHER

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

Interventions

data collection

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• Pregnancy
• Patients under legal protection measures

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Anne Pr BACHELOT

Role: CONTACT

anne.bachelot@aphp.fr

0033 01 42 16 02 46

Other Identifiers

APHP251139

Identifier Type: -

Identifier Source: org_study_id