Polycystic Ovary SyndromeNCT06164132
Pivotal Influence of Obesity on Body Composition and Ovarian Doppler in Different Polycystic Ovarian Syndrome Phenotypes
An observational study of Polycystic Ovary Syndrome and Obesity, run by Cairo University at 1 site in Egypt.
Trial summary
The study aimed to explore the impact of obesity on both body composition and ovarian Doppler parameters across various phenotypes of females diagnosed with polycystic ovarian syndrome (PCOS). Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Polycystic Ovary Syndrome, Obesity
- What is being tested?
- Evaluation
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jul 2023to 31 Oct 2023
- 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 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Study population: They were recruited from the gynecology and infertility clinic, for Doppler sonographic examination and body composition analysis.
Who may be able to join
- Age ranged from 18 to 40 years old.
- Individuals with Polycystic Ovary Syndrome (PCOS) should exhibit at least two of the three features outlined in the Rotterdam criteria for diagnosis, encompassing oligo- or anovulation, clinical and/or biochemical indications of hyperandrogenism, and the presence of polycystic ovaries as identified through ultrasonography.
Who cannot join
- Congenital adrenal hyperplasia
- Thyroid dysfunction
- Hyperprolactinemia
- Androgen-secreting tumors
- Cushing syndrome
- Undergoing any medical therapy for the treatment of PCOS or for weight loss.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Pivotal Influence of Obesity on Body Composition and Ovarian Doppler in Different Polycystic Ovarian Syndrome Phenotypes: An Observational Study
The study aimed to explore the impact of obesity on both body composition and ovarian Doppler parameters across various phenotypes of females diagnosed with polycystic ovarian syndrome (PCOS). Additionally, the investigation seeked to establish correlations between these parameters and their prevalence concerning the clinical criteria of PCOS.
Read the detailed description
Polycystic ovarian syndrome (PCOS) is a complex and multifactorial condition characterized by endocrinological, reproductive, metabolic, and biochemical abnormalities, affecting 12% to 21% of reproductive-aged females. It has emerged as a significant global public health concern. However, variations in diagnostic criteria and patient selection have led to considerable discrepancies in the absolute prevalence of PCOS and its temporal trends. Previous studies have examined ovarian volume and blood flow indices in both obese and non-obese females with PCOS, albeit employing different criteria for obesity classification. Notably, none have compared these parameters across normal weight, overweight, and obese PCOS females. Therefore, the current study aims to explore the impact of obesity on body composition and ovarian Doppler parameters within distinct PCOS phenotypes. An additional objective is to assess correlations between anthropometric, body composition, and ovarian Doppler parameters and the prevalence of PCOS symptoms.
- Conditions
- Polycystic Ovary Syndrome, Obesity
- Being tested
- Evaluation
- Keywords
- Polycystic Ovary Syndrome, Obesity, Body composition, Ovarian Doppler
- Medical subject headings
- Polycystic Ovary Syndrome, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EvaluationOther
Evaluation through PCOS Phenotypes, measurements of Body weight, height, waist and hip circumferences, Dual-energy X-ray absorptiometry, and Sonographic examination.
| Study group | Role | What they receive |
|---|---|---|
| Normal Weight group | Their BMI ranged from 18.5 to 24.9 kg/m2. Receives: Other: Evaluation | |
| Overweight group | Their BMI ranged from 25 to 29.9 kg/m2. Receives: Other: Evaluation | |
| Obese group | Their BMI was ≥ 30 kg/m2. Receives: Other: Evaluation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phenotypes of PCOS
The patients were categorized into four distinct phenotypes: Type I, characterized by oligomenorrhea/amenorrhea and hyperandrogenism (O+H); Type II, exhibiting polycystic ovaries and hyperandrogenism (P+H); Type III, featuring oligomenorrhea/amenorrhea and polycystic ovaries (O+P); and Type IV, presenting with oligomenorrhea/amenorrhea, polycystic ovaries, and hyperandrogenism (O+P+H).
Measured: 4 months
Body mass index (BMI)
The height and weight were determined for each female in the three groups to calculate her BMI = (weight in kg)/(height in m2)
Measured: 4 months
Waist hip ratio (WHR)
The waist and hip circumferences were taken for each female in the three groups for calculating waist and hip ratio (WHR) by dividing waist circumference (WC) on the hip circumference (HC).
Measured: 4 months
Total and regional fat mass
They were measured by Dual-energy X-ray absorptiometry.
Measured: 4 months
Total and regional lean mass
They were measured by Dual-energy X-ray absorptiometry.
Measured: 4 months
Ovarian volume
The ovarian volume was computed utilizing the ellipsoid formula, which involves multiplying the dimensions of length, width, and height by a constant factor of 0.523.
Measured: 4 months
Peak systolic velocity (PSV)
It was recorded for each female in the three groups by Color Doppler ultrasound.
Measured: 4 months
End diastolic velocity (EDV)
It was recorded for each female in the three groups by Color Doppler ultrasound.
Measured: 4 months
Resistive index (RI)
The Resistance Index (RI) was determined by dividing the difference between Peak Systolic Velocity (PSV) and End Diastolic Velocity (EDV) by PSV. A lower value of RI is indicative of increased blood flow
Measured: 4 months
Pulsatility index (PI)
The Pulsatility Index (PI) was calculated by dividing the difference between Peak Systolic Velocity (PSV) and End Diastolic Velocity (EDV) by the mean maximum flow velocity. A reduced PI value is indicative of heightened blood flow.
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2023
- Study start1 Jul 2023
- Primary completion31 Oct 2023
- Study completion31 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Polycystic Ovary SyndromeStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Collaborators
- Helwan University, National Research Centre, Egypt
- Responsible party
- Principal investigator, Doaa A. Osman, Cairo University
- Investigators
- Safenaz Y. El Sherity, Assis. Prof., Principal investigator, National Research Centre, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06164132
- Sponsor's protocol ID
- P.T.REC/012/004609
- Status last verified
- Feb 2024
- First submitted
- 1 Dec 2023
- Last updated
- 14 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Pivotal Influence of Obesity on Body Composition and Ovarian Doppler in Different Polycystic Ovarian Syndrome Phenotypes: An Observational Study
- ClinicalTrials.gov ID
- NCT06164132
- Acronym / sponsor ID
- P.T.REC/012/004609
- Conditions
- Polycystic Ovary Syndrome, Obesity
- Keywords
- Polycystic Ovary Syndrome, Obesity, Body composition, Ovarian Doppler
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Collaborators
- Helwan University, National Research Centre, Egypt
- Study start
- 1 Jul 2023 (actual)
- Primary completion
- 31 Oct 2023 (actual)
- Study completion
- 31 Oct 2023 (actual)
- First posted
- 11 Dec 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.
The study aimed to explore the impact of obesity on both body composition and ovarian Doppler parameters across various phenotypes of females diagnosed with polycystic ovarian syndrome (PCOS). Additionally, the investigation seeked to establish correlations between these parameters and their prevalence concerning the clinical criteria of PCOS.
Detailed description
Polycystic ovarian syndrome (PCOS) is a complex and multifactorial condition characterized by endocrinological, reproductive, metabolic, and biochemical abnormalities, affecting 12% to 21% of reproductive-aged females. It has emerged as a significant global public health concern. However, variations in diagnostic criteria and patient selection have led to considerable discrepancies in the absolute prevalence of PCOS and its temporal trends. Previous studies have examined ovarian volume and blood flow indices in both obese and non-obese females with PCOS, albeit employing different criteria for obesity classification. Notably, none have compared these parameters across normal weight, overweight, and obese PCOS females. Therefore, the current study aims to explore the impact of obesity on body composition and ovarian Doppler parameters within distinct PCOS phenotypes. An additional objective is to assess correlations between anthropometric, body composition, and ovarian Doppler parameters and the prevalence of PCOS symptoms.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Normal Weight group | – | Other: EvaluationTheir BMI ranged from 18.5 to 24.9 kg/m2. |
| Overweight group | – | Other: EvaluationTheir BMI ranged from 25 to 29.9 kg/m2. |
| Obese group | – | Other: EvaluationTheir BMI was ≥ 30 kg/m2. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- They were recruited from the gynecology and infertility clinic, for Doppler sonographic examination and body composition analysis.
Key inclusion criteria (2 listed)
- Age ranged from 18 to 40 years old.
- Individuals with Polycystic Ovary Syndrome (PCOS) should exhibit at least two of the three features outlined in the Rotterdam criteria for diagnosis, encompassing oligo- or anovulation, clinical and/or biochemical indications of hyperandrogenism, and the presence of polycystic ovaries as identified through ultrasonography.
Key exclusion criteria (6 listed)
- Congenital adrenal hyperplasia
- Thyroid dysfunction
- Hyperprolactinemia
- Androgen-secreting tumors
- Cushing syndrome
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 |
|---|---|---|
| EvaluationEvaluation through PCOS Phenotypes, measurements of Body weight, height, waist and hip circumferences, Dual-energy X-ray absorptiometry, and Sonographic examination. | Other | Normal Weight group, Obese group, Overweight group |
Primary outcome
Phenotypes of PCOS
Time frame: 4 months
The patients were categorized into four distinct phenotypes: Type I, characterized by oligomenorrhea/amenorrhea and hyperandrogenism (O+H); Type II, exhibiting polycystic ovaries and hyperandrogenism (P+H); Type III, featuring oligomenorrhea/amenorrhea and polycystic ovaries (O+P); and Type IV, presenting with oligomenorrhea/amenorrhea, polycystic ovaries, and hyperandrogenism (O+P+H).
Body mass index (BMI)
Time frame: 4 months
The height and weight were determined for each female in the three groups to calculate her BMI = (weight in kg)/(height in m2)
Waist hip ratio (WHR)
Time frame: 4 months
The waist and hip circumferences were taken for each female in the three groups for calculating waist and hip ratio (WHR) by dividing waist circumference (WC) on the hip circumference (HC).
Total and regional fat mass
Time frame: 4 months
They were measured by Dual-energy X-ray absorptiometry.
Total and regional lean mass
Time frame: 4 months
They were measured by Dual-energy X-ray absorptiometry.
Ovarian volume
Time frame: 4 months
The ovarian volume was computed utilizing the ellipsoid formula, which involves multiplying the dimensions of length, width, and height by a constant factor of 0.523.
Peak systolic velocity (PSV)
Time frame: 4 months
It was recorded for each female in the three groups by Color Doppler ultrasound.
End diastolic velocity (EDV)
Time frame: 4 months
It was recorded for each female in the three groups by Color Doppler ultrasound.
Resistive index (RI)
Time frame: 4 months
The Resistance Index (RI) was determined by dividing the difference between Peak Systolic Velocity (PSV) and End Diastolic Velocity (EDV) by PSV. A lower value of RI is indicative of increased blood flow
Pulsatility index (PI)
Time frame: 4 months
The Pulsatility Index (PI) was calculated by dividing the difference between Peak Systolic Velocity (PSV) and End Diastolic Velocity (EDV) by the mean maximum flow velocity. A reduced PI value is indicative of heightened blood flow.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2024.
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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.
Safenaz Y. El Sherity, Assis. Prof. principal investigator
National Research Centre, Egypt
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 Polycystic Ovary Syndrome and Obesity, run by Cairo University at 1 site in Egypt.
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 2 inclusion and 6 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: finished, as of the sponsor's last update on 14 Feb 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 Egypt. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phenotypes of PCOS (time frame: 4 months). The study lists 10 primary outcomes in all. 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 14 Feb 2024.