To hear about similar clinical trials, please enter your email below
Trial Title:
The Frequency of Polycystic Ovary Syndrome Among Young Reproductive Females Presenting With Hyperandrogenism: a Mixed Cohort Study
NCT ID:
NCT05734287
Condition:
PCOS (Polycystic Ovary Syndrome) of Bilateral Ovaries
Conditions: Official terms:
Polycystic Ovary Syndrome
Hyperandrogenism
Syndrome
Study type:
Observational [Patient Registry]
Overall status:
Recruiting
Study design:
Time perspective:
Other
Intervention:
Intervention type:
Diagnostic Test
Intervention name:
clinical, biophysical and biochemical assessment of young females with clinical hyperandrogenism
Description:
To assess clinical, biophysical and biochemical criteria of young females with clinical
hyperandrogenism as a search for PCOS
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.
Criteria for eligibility:
Study pop:
Females with clinical hyperandrogenism.
Sampling method:
Probability Sample
Criteria:
Inclusion Criteria:
- Clinical hyperandrogenism
Exclusion Criteria:
- Age less than 15 or more than 35 years.
Gender:
Female
Minimum age:
15 Years
Maximum age:
35 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Atif Dervis
Address:
City:
Doha
Country:
Qatar
Status:
Recruiting
Contact:
Last name:
Atif Dervis, MD PhD
Phone:
097430200336
Email:
atef_darwish@yahoo.com
Contact backup:
Last name:
Tarek ElShawaf, MD
Phone:
097431161446
Email:
Melshawaf@phcc.gov.qa
Start date:
June 28, 2024
Completion date:
August 1, 2025
Lead sponsor:
Agency:
Woman's Health University Hospital, Egypt
Agency class:
Other
Source:
Woman's Health University Hospital, Egypt
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05734287
