Polycystic Ovarian Syndrome (PCOS) Biomarker Evaluation Study

Recruiting

• Conditions: Polycystic Ovarian Syndrome (PCOS)

• Registration Number: NCT06642831
• Lead Sponsor: University Hospital Erlangen

Brief Summary

The purpose of the study is to validate recently identified biomarkers for the identification of PCOS in adolecent and young adult women.

Detailed Description

The purpose of the study is to validate potential biomarkers for the aid in the diagnosis of PCOS in adolescent and young adult women in the age range of 15-25 years. Female subjects included in this study will have one visit where clinical data for assessing PCOS will be collected and a blood draw will be performed to collect serum for measurement of parameters relevant to PCOS will be performed. Study subjects that receive a PCOS diagnosis will have two follow up visits for follow up on treatment where additional serum and clinical data will be collected. The first visit will be 3 months after receiving the diagnosis and the second visit 6-12 months after the initial visit.

Study Timeline

• Study Start: 2023-01-31
• Status Verified: 2024-04
• Study First Submitted: 2024-10-09
• Study First Submitted QC: 2024-10-14
• Last Update Submitted: 2024-10-14
• Study First Posted: 2024-10-15
• Last Update Posted: 2024-10-15
• Primary Completion: 2026-12
• Study Completion: 2027-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 380

Inclusion Criteria

• Female subjects age 15-25 years
• Signed written informed consent

Exclusion Criteria

• Less than 1 years from onset of menarche
• Use of hormonal contraceptives
• Documented ongoing pregnancy
• Major ovarian abnormalities, including subject with only one ovary, cysts and solid masses > 2 cm as detected by transvaginal ultrasound
• Malignancy ( documented malignancy, documentation of current radiation therapy or chemotherapy in medical record)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The validation of new potential biomarkers for aid in the diagnoisis of PCOS in adolescent and young adult women	Baseline

Trial Locations

Locations (1)

Department of Obstetrics and Gynecology, University Erlangen Hospital, Friedrich Alexander University of Erlangen-Nuremberg, Erlangen, Germany; 🇩🇪 Erlangen, Germany