PCOS (Polycystic Ovary Syndrome) of Bilateral OvariesNCT05734287
The Frequency of Polycystic Ovary Syndrome Among Young Reproductive Females Presenting With Hyperandrogenism: a Mixed Cohort Study
An observational study of PCOS (Polycystic Ovary Syndrome) of Bilateral Ovaries, run by Woman's Health University Hospital, Egypt at 1 site in Qatar.
Trial 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… Read more about this study
- Who is it for?
- Ages 15 to 35 years, women only
- Conditions the study is for
- PCOS (Polycystic Ovary Syndrome) of Bilateral Ovaries
- What is being tested?
- clinical, biophysical and biochemical assessment of young females with clinical hyperandrogenism
- How many people
- 260 participants
- Where
- 1 siteQatar
- Study dates
- 28 Jun 2024to 1 Aug 2025
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 35 years
- Women only
- No healthy volunteers
- Child, Adult
Study population: Females with clinical hyperandrogenism.
Who may be able to join
- Clinical hyperandrogenism
Who cannot join
- Age less than 15 or more than 35 years.
Trial locations and contacts
1 site in 1 country.
Qatar1 site, 1 recruiting
- Recruiting
Atif Dervis
Doha
Atif Dervis, MD PhD, 097430200336, atef_darwish@yahoo.com
Tarek ElShawaf, MD, 097431161446, Melshawaf@phcc.gov.qa
About this study
Official title: Polycystic Ovaries in Young Girls Presenting With Hyperandrogenism
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.
- Being tested
- clinical, biophysical and biochemical assessment of young females with clinical hyperandrogenism
- Medical subject headings
- Polycystic Ovary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
clinical, biophysical and biochemical assessment of young females with clinical hyperandrogenismDiagnostic test
To assess clinical, biophysical and biochemical criteria of young females with clinical hyperandrogenism as a search for PCOS
What is being measured
The primary outcome is the main question the study is designed to answer.
The frequency of polycystic ovary syndrome among young reproductive females presenting with hyperandrogenism: a mixed cohort study
Measured: 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2023
- Study start28 Jun 2024
- Primary completion15 Jul 2025 (estimated)
- Study completion1 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PCOS (Polycystic Ovary Syndrome) of Bilateral OvariesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 260 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Woman's Health University Hospital, Egypt
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Professor Atef Darwish, Woman's Health University Hospital, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05734287
- Sponsor's protocol ID
- 123456
- Status last verified
- Jul 2024
- First submitted
- 6 Feb 2023
- Last updated
- 23 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Protocol
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Polycystic Ovaries in Young Girls Presenting With Hyperandrogenism
- ClinicalTrials.gov ID
- NCT05734287
- Acronym / sponsor ID
- 123456
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 260 participants (estimated)
- Lead sponsor
- Woman's Health University Hospital, EgyptUniversity, hospital or other
- Study start
- 28 Jun 2024 (actual)
- Primary completion
- 15 Jul 2025 (estimated)
- Study completion
- 1 Aug 2025 (estimated)
- First posted
- 17 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 6 Months
Who may qualify
- Ages
- 15 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Females with clinical hyperandrogenism.
Key inclusion criteria (1 listed)
- Clinical hyperandrogenism
Key exclusion criteria (1 listed)
- Age less than 15 or more than 35 years.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| clinical, biophysical and biochemical assessment of young females with clinical hyperandrogenismTo assess clinical, biophysical and biochemical criteria of young females with clinical hyperandrogenism as a search for PCOS | Diagnostic test | – |
Primary outcome
The frequency of polycystic ovary syndrome among young reproductive females presenting with hyperandrogenism: a mixed cohort study
Time frame: 7 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2024.
- Individual participant dataSharing planned: Yes. Protocol
Related trials for PCOS (Polycystic Ovary Syndrome) of Bilateral Ovaries
RecruitingPhase 3
Role of Semaglutide in Restoring Ovulation in Youth and Adults With Polycystic Ovary Syndrome
PCOS (Polycystic Ovary Syndrome) of Bilateral Ovaries, Obese
Active, not recruiting
Glucose Evaluation Through Continuous Glucose Monitors in Polycystic Ovary Syndrome
PCOS (Polycystic Ovary Syndrome) of Bilateral Ovaries, Dysglycemia
Not yet recruitingObservational study
Evaluation of Fibromyalgia Frequency and Pain Parameters in Women With Polycystic Ovary Syndrome
Fibromyalgia, PCOS (Polycystic Ovary Syndrome) of Bilateral Ovaries
RecruitingPhase 2
Effects of Adding Quercetin or Alpha Lipoic Acid to Usual Care on Symptoms and Blood Markers in Iraqi Women With Polycystic Ovary Syndrome
PCOS (Polycystic Ovary Syndrome) of Bilateral Ovaries
Recruiting
Best Treatment for Women With Both (Polycystic Ovary Syndrome) PCOS and Subclinical Hypothyroidism
PCOS (Polycystic Ovary Syndrome) of Bilateral Ovaries, Subclinical Hypothyroidism
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of PCOS (Polycystic Ovary Syndrome) of Bilateral Ovaries, run by Woman's Health University Hospital, Egypt at 1 site in Qatar.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Qatar. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The frequency of polycystic ovary syndrome among young reproductive females presenting with hyperandrogenism: a mixed cohort study (time frame: 7 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2024.