The Frequency of Polycystic Ovary Syndrome Among Young Reproductive Females Presenting With Hyperandrogenism: a Mixed Cohort Study

Last updated: July 22, 2024
Sponsor: Woman's Health University Hospital, Egypt
Overall Status: Active - Recruiting

Phase

N/A

Condition

Testotoxicosis

Polycystic Ovarian Syndrome

Testotoxikose

Treatment

clinical, biophysical and biochemical assessment of young females with clinical hyperandrogenism

Clinical Study ID

NCT05734287
123456
  • Ages 15-35
  • Female

Study Summary

This mixed cohort study will test the frequency of PCOS among young females presenting with one of the clinical hyperandrogenism criteria: acne, hirsutism and/or hair loss. Diagnosis will be based on the recent PCOS clinical, biochemical and biophysical criteria recently published " International evidence-based guideline for the assessment and management of polycystic ovary syndrome (PCOS) 2018".

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Clinical hyperandrogenism

Exclusion

Exclusion Criteria:

  • Age less than 15 or more than 35 years.

Study Design

Total Participants: 260
Treatment Group(s): 1
Primary Treatment: clinical, biophysical and biochemical assessment of young females with clinical hyperandrogenism
Phase:
Study Start date:
June 28, 2024
Estimated Completion Date:
August 01, 2025

Study Description

Irregular menstrual cycles are defined as:

  • normal in the first year post menarche as part of the pubertal transition

  • > 1 to < 3 years post menarche: < 21 or > 45 days

  • > 3 years post menarche to perimenopause: < 21 or > 35 days or < 8 cycles per year

  • > 1 year post menarche > 90 days for any one cycle

  • Primary amenorrhea by age 15 or > 3 years post thelarche (breast development) When irregular menstrual cycles are present a diagnosis of PCOS should be considered.

Biochemical hyperandrogenism: Calculated free testosterone, free androgen index or calculated bioavailable testosterone. Androstenedione and dehydroepiandrosterone sulfate (DHEAS) could be considered if total or free testosterone are not elevated. (ELIZA or radioimmunoassay).

A comprehensive history and physical examination should be completed for symptoms and signs of clinical hyperandrogenism, including acne, alopecia and hirsutism and, in adolescents, severe acne and hirsutism using the modified Ferriman Gallwey score (mFG). Transvaginal (transabdominal if virgins) Ultrasound and polycystic ovarian morphology: Ultrasound should not be used for the diagnosis of PCOS in those with a gynaecological age of < 8 years (< 8 years after menarche), due to the high incidence of multi-follicular ovaries in this life stage. Transabdominal ultrasound reporting is best focused on ovarian volume with a threshold of ≥ 10ml. Endovaginal U/S should show a follicle number per ovary of ≥ 20 and/or an ovarian volume ≥ 10ml, ensuring no corpora lutea, cysts or dominant follicles are present.

Connect with a study center

  • Atif Dervis

    Doha,
    Qatar

    Active - Recruiting

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