Polycystic Ovarian Syndrome (PCOS) Biomarker Evaluation Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Polycystic Ovarian Syndrome (PCOS). Basic parameters: 15 years — 25 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Germany
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Polycystic Ovarian Syndrome (PCOS) in Human Adolescent and Young Adult Females - Biomarker Evaluation Study (PHOEBE)
Overview
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.
Primary outcome measures
- The validation of new potential biomarkers for aid in the diagnoisis of PCOS in adolescent and young adult women [Time frame: Baseline]
Eligibility criteria
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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Case-control
Study locations
Germany · 1 center
- Department of Obstetrics and Gynecology, University Erlangen Hospital, Friedrich Alexander — Erlangen
Identifiers
NCT: NCT06642831 · 22-114-B