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

Results pending

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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Recruitment Status

RECRUITING

Total Enrollment

260 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-06-28

Study Completion Date

2025-08-01

Brief Summary

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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

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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.

Conditions

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PCOS (Polycystic Ovary Syndrome) of Bilateral Ovaries

Study Design

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Observational Model Type

COHORT

Study Time Perspective

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* Clinical hyperandrogenism

Exclusion Criteria

* Age less than 15 or more than 35 years.
Minimum Eligible Age

15 Years

Maximum Eligible Age

35 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Woman's Health University Hospital, Egypt

OTHER

Sponsor Role lead

Responsible Party

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Professor Atef Darwish

Professor of Obstetrics and Gynecology

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Atif Dervis

Doha, , Qatar

Site Status RECRUITING

Countries

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Qatar

Facility Contacts

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Atif Dervis, MD PhD

Role: primary

097430200336

Tarek ElShawaf, MD

Role: backup

097431161446

Other Identifiers

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123456

Identifier Type: -

Identifier Source: org_study_id

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