Polycystic Ovarian Syndrome (PCOS) Biomarker Evaluation Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

380 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-01-31

Study Completion Date

2027-03-31

Brief Summary

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

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Detailed Description

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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.

Conditions

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Polycystic Ovarian Syndrome (PCOS)

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Women with PCOS

Women in the age range of 15-25 years fulfilling the PCOS criteria defined by the International Evidence-based Guideline

No interventions assigned to this group

Women without PCOS (controls)

Women in the age range of 15-25 years who are negative for the diagnostic criteria of PCOS according to the International Evidence based guideline

No interventions assigned to this group

Eligibility Criteria

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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)

Minimum Eligible Age

15 Years

Maximum Eligible Age

25 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes