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

Recruiting

• Conditions: PCOS (Polycystic Ovary Syndrome) of Bilateral Ovaries

• Registration Number: NCT05734287
• Lead Sponsor: Woman's Health University Hospital, Egypt

Brief 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".

Detailed 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.

Study Timeline

• Study First Submitted: 2023-02-06
• Study First Submitted QC: 2023-02-15
• Study First Posted: 2023-02-17
• Study Start: 2024-06-28
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-22
• Last Update Posted: 2024-07-23
• Primary Completion: 2025-07-15
• Study Completion: 2025-08-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 260

Inclusion Criteria

• Clinical hyperandrogenism

Exclusion Criteria

• Age less than 15 or more than 35 years.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The frequency of polycystic ovary syndrome among young reproductive females presenting with hyperandrogenism: a mixed cohort study	7 months

Trial Locations

Locations (1)

Atif Dervis; 🇶🇦 Doha, Qatar