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RecruitingNCT05734287Updated Jul 23, 2024

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

An observational study in PCOS (Polycystic Ovary Syndrome) of Bilateral Ovaries, sponsored by Woman's Health University Hospital, Egypt. Recruiting at 1 site in Qatar. Open to female participants aged 15 Years to 35 Years. Per ClinicalTrials.gov, last updated 2024-07-23.

Sponsored by Woman's Health University Hospital, Egypt · Observational

From the registry’s dates

  • Primary completion was expected by Jul 2025, 1 year 3 months ago, but the record still lists the study as recruiting.
  • Started Jun 2024; still recruiting 2 years 4 months later.
Study type
Observational
Model
Cohort
Time perspective
Other
Enrollment
260
Ages
15 Years to 35 Years
Sex
Female
01

Study 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".

Read the 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.

02

Conditions studied

  • PCOS (Polycystic Ovary Syndrome) of Bilateral Ovaries
03

In context

Polycystic Ovary Syndrome

956 studies on the registry are indexed under Polycystic Ovary Syndrome; 176 are open to participants now.

This study's planned enrollment of 260 is above the median of 118 across 223 observational studies indexed under Polycystic Ovary Syndrome.

Browse Polycystic Ovary Syndrome studies →

Lead sponsor

Woman's Health University Hospital, Egypt is the lead sponsor of 46 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
15 Years to 35 Years
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Females with clinical hyperandrogenism.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Clinical hyperandrogenism

Exclusion criteria

Exclusion Criteria:

  • Age less than 15 or more than 35 years.
05

Study design

Observational model
Cohort
Time perspective
Other
Enrollment
260 participants (estimated)
Target follow-up
6 Months
Patient registry
Yes

Interventions

  • Diagnostic testclinical, 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

06

What researchers measure

Primary outcomes

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

    Time frame: 7 months

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: Yes — Protocol

Supporting information: Study protocol

Time frame: 3 months

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jun 2024 (actual). Primary completion is estimated for Jul 2025, 12 months after the start.

Of 71 non-industry observational studies under Polycystic Ovary Syndrome, half reached primary completion within 14 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 47. This study's planned 12 months is below that.

Counting every sponsor, half of 74 studies reached it within 14 months; a quarter within 6 and three quarters within 48.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 6, 2023
First posted
Feb 17, 2023
StartActual
Jun 28, 2024
Primary completionEst.
Jul 15, 2025
CompletionEst.
Aug 1, 2025
Last update
Jul 23, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 23, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05734287
Lead sponsor
Woman's Health University Hospital, Egypt
Responsible party
Professor Atef Darwish (Professor of Obstetrics and Gynecology, Woman's Health University Hospital, Egypt) — Principal investigator
First posted
Feb 17, 2023
Start date
Jun 28, 2024
Primary completion
Jul 15, 2025 (estimated)
Completion
Aug 1, 2025 (estimated)
Last update
Jul 23, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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