What are the necessary clinical evaluations and laboratory tests to diagnose Polycystic Ovary Syndrome (PCOS)?

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Diagnosis of Polycystic Ovary Syndrome (PCOS)

The diagnosis of PCOS requires at least two of three Rotterdam criteria: chronic anovulation, hyperandrogenism (clinical or biochemical), and polycystic ovaries on ultrasound, with exclusion of other disorders. 1

Diagnostic Criteria

The Rotterdam criteria are the most widely accepted diagnostic framework for PCOS, requiring the presence of at least two of the following three criteria:

  1. Chronic anovulation/oligo-ovulation - manifested as:

    • Menstrual irregularity (cycle length >35 days)
    • Fewer than 8 menstrual cycles per year
    • Absence of menstruation for >3 months
  2. Hyperandrogenism

    • Clinical signs: Hirsutism, acne, male-pattern alopecia
    • Biochemical markers: Elevated androgens in laboratory testing
  3. Polycystic ovaries on ultrasound

    • ≥20 follicles (2-9mm) per ovary OR
    • Ovarian volume ≥10ml 1

Laboratory Evaluation

First-Line Tests for Biochemical Hyperandrogenism

  • Total testosterone (TT) - sensitivity 74%, specificity 86% 1
  • Free testosterone (FT) - sensitivity 89%, specificity 83% 1
    • Ideally measured by mass spectrometry or equilibrium dialysis
  • Free Androgen Index (FAI) - sensitivity 78%, specificity 85% 1
    • Good alternative when mass spectrometry is unavailable

Additional Androgen Tests

  • Androstenedione (A4) - sensitivity 75%, specificity 71% 1
  • Dehydroepiandrosterone sulfate (DHEAS) - sensitivity 75%, specificity 67% 1
  • Calculated bioavailable testosterone - sensitivity 76%, specificity 83% 1

Exclusion of Other Disorders

  • Thyroid-stimulating hormone (TSH) - to rule out thyroid disorders
  • Prolactin - to exclude hyperprolactinemia
  • 17-hydroxyprogesterone - to rule out congenital adrenal hyperplasia
  • Overnight dexamethasone suppression test or 24-hour urinary free cortisol - to exclude Cushing's syndrome 1

Metabolic Assessment

  • Fasting lipid profile
  • Fasting glucose/insulin ratio
  • 2-hour 75g oral glucose tolerance test (OGTT) - especially for patients with BMI >25 kg/m² 1

Ultrasound Evaluation

  • Diagnostic threshold: ≥20 follicles (2-9mm) per ovary OR ovarian volume ≥10ml 1
  • Timing: Best performed in early follicular phase in menstruating women
  • Important note: Ultrasound findings alone are insufficient for diagnosis and must be correlated with clinical and biochemical findings 1
  • Adolescents: Ultrasound is not recommended as first-line investigation in women <17 years due to high prevalence of multicystic ovaries in this age group 2

Special Considerations

Adolescents

  • Diagnosis is challenging due to overlap with normal pubertal changes
  • Persistent oligomenorrhea 2-3 years post-menarche suggests PCOS
  • Focus on clinical hyperandrogenism and menstrual irregularities rather than ultrasound 2

Diagnostic Pitfalls to Avoid

  1. Relying solely on ultrasound - PCOS is a clinical diagnosis requiring correlation with symptoms and biochemical findings
  2. Using inappropriate testosterone assays - Direct immunoassays have lower accuracy; mass spectrometry is preferred 3
  3. Failing to exclude other disorders - Several conditions can mimic PCOS
  4. Not considering phenotypic variations - Different PCOS phenotypes have varying clinical presentations and long-term risks 4

Diagnostic Algorithm

  1. Assess menstrual pattern - Document cycle length, regularity, and amenorrhea
  2. Evaluate for clinical hyperandrogenism - Hirsutism, acne, alopecia
  3. Order appropriate laboratory tests - TT, FT or FAI as first line; exclusionary tests as needed
  4. Consider ultrasound - If diagnosis remains unclear after clinical and laboratory assessment
  5. Exclude other disorders - Thyroid disease, hyperprolactinemia, Cushing's syndrome, congenital adrenal hyperplasia
  6. Apply Rotterdam criteria - Confirm presence of at least two of three criteria
  7. Document PCOS phenotype - For appropriate management and risk assessment

By following this systematic approach, clinicians can accurately diagnose PCOS and develop appropriate management strategies for affected women.

References

Guideline

Diagnosis and Management of Polycystic Ovary Syndrome (PCOS)

Praxis Medical Insights: Practical Summaries of Clinical Guidelines, 2025

Guideline

Guideline Directed Topic Overview

Dr.Oracle Medical Advisory Board & Editors, 2025

Research

Polycystic Ovary Syndrome.

Obstetrics and gynecology, 2018

Professional Medical Disclaimer

This information is intended for healthcare professionals. Any medical decision-making should rely on clinical judgment and independently verified information. The content provided herein does not replace professional discretion and should be considered supplementary to established clinical guidelines. Healthcare providers should verify all information against primary literature and current practice standards before application in patient care. Dr.Oracle assumes no liability for clinical decisions based on this content.

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