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NCT Number: NCT05734287

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

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".

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Clinical hyperandrogenism

Exclusion criteria

  • Age less than 15 or more than 35 years.

Treatment and study plan

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

Diagnostic Test

To assess clinical, biophysical and biochemical criteria of young females with clinical hyperandrogenism as a search for PCOS

Primary outcomes

  1. The frequency of polycystic ovary syndrome among young reproductive females presenting with hyperandrogenism: a mixed cohort study

    Time frame: 7 months

Sponsors and collaborators

Lead sponsor

Woman's Health University Hospital, Egypt

Other

Registry information

Official study title

Polycystic Ovaries in Young Girls Presenting With Hyperandrogenism

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Feb 17, 2023
Registry last updated
Jul 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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