Polycystic Ovarian Syndrome (PCOS) Biomarker Evaluation Study

Last updated: October 14, 2024
Sponsor: University Hospital Erlangen
Overall Status: Active - Recruiting

Phase

N/A

Condition

Polycystic Ovarian Syndrome

Reproductive Health

Treatment

N/A

Clinical Study ID

NCT06642831
22-114-B
  • Ages 15-25
  • Female
  • Accepts Healthy Volunteers

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Female subjects age 15-25 years

  • Signed written informed consent

Exclusion

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 solidmasses > 2 cm as detected by transvaginal ultrasound

  • Malignancy ( documented malignancy, documentation of current radiation therapy orchemotherapy in medical record)

Study Design

Total Participants: 380
Study Start date:
January 31, 2023
Estimated Completion Date:
March 31, 2027

Study 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.

Connect with a study center

  • Department of Obstetrics and Gynecology, University Erlangen Hospital, Friedrich Alexander University of Erlangen-Nuremberg, Erlangen, Germany

    Erlangen, 91054
    Germany

    Active - Recruiting

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