The Frequency of Polycystic Ovary Syndrome Among Young Reproductive Females Presenting With Hyperandrogenism: a Mixed Cohort Study
NCT ID: NCT05734287
Last Updated: 2024-07-23
Study Results
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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RECRUITING
260 participants
OBSERVATIONAL
2024-06-28
2025-08-01
Brief Summary
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Detailed Description
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* 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.
Conditions
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Study Design
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COHORT
OTHER
Interventions
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clinical, biophysical and biochemical assessment of young females with clinical hyperandrogenism
To assess clinical, biophysical and biochemical criteria of young females with clinical hyperandrogenism as a search for PCOS
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
15 Years
35 Years
FEMALE
No
Sponsors
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Woman's Health University Hospital, Egypt
OTHER
Responsible Party
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Professor Atef Darwish
Professor of Obstetrics and Gynecology
Locations
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Atif Dervis
Doha, , Qatar
Countries
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Facility Contacts
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Other Identifiers
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123456
Identifier Type: -
Identifier Source: org_study_id
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