Study the Relationship Between Insulin Resistance With Hormonal and Ovarian Morphological Characteristics in Patients With Polycystic Ovarian SyndromeNCT05661565
Correlation of Insulin Resistance With Hormonal and Ovarian Morphological Characteristics in Patients With Polycystic Ovarian Syndrome
An observational study of Study the Relationship Between Insulin Resistance With Hormonal and Ovarian Morphological Characteristics in Patients With Polycystic Ovarian Syndrome, run by Cairo University.
Trial summary
We designed a study to determine if ovarian volume (OV) and/or follicle number (FN) are independently associated with abnormal metabolic findings in women diagnosed with PCOS. We hypothesized that ovarian morphology but not follicle number would be associated with a significantly higher odds of hyperinsulinemia among… Read more about this study
- Who is it for?
- Ages 16 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Study the Relationship Between Insulin Resistance With Hormonal and Ovarian Morphological Characteristics in Patients With Polycystic Ovarian Syndrome
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2023to 31 Jul 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 16 to 45 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Study population: Women with PCOS attending the outpatient clinic in Kasr Alainy Hospital in the reproductive age group (20:40 years)
Who may be able to join
- A-patients met the Rotterdam criteria of PCO with two out of three of the following:
- oligo-or-anovulation
- clinical and/or biochemical hyperandrogenism
- the presence of 10 or more antral follicles in one ovary and/or a maximum ovarian volume > 10cc B-reproductive age group (16:45 years) C-BMI <40
Who cannot join
- A-age >40 years B-BMI>40 C-previous ovarian surgery D-chronic medical disorders [DM , HTN , ...]
Trial locations and contacts
No sites are listed yet.
About this study
We designed a study to determine if ovarian volume (OV) and/or follicle number (FN) are independently associated with abnormal metabolic findings in women diagnosed with PCOS. We hypothesized that ovarian morphology but not follicle number would be associated with a significantly higher odds of hyperinsulinemia among women with PCOS.
- Being tested
- No intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
We try to find an association between insulin resistance with ovarian hormonal and morphological characteristics in patients with polycystic ovarian syndrome
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between the ovarian volume and Insulin resistance
Measured: January 2023- June 2023
Correlation between the antral follicular count and insulin resistance
Measured: January 2023- June 2023
Secondary outcomes (5)
Correlation between anti-mullerian hormone values and insulin resistance
Measured: January 2023- June 2023
Correlation between FSH values and insulin resistance
Measured: January 2023- June 2023
Correlation between LH values and insulin resistance
Measured: January 2023- June 2023
Correlation between body mass index and insulin resistance
Measured: January 2023- June 2023
Correlation between hirsutism and insulin resistance
Measured: January 2023- June 2023
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2022
- Study start1 Jan 2023 (estimated)
- Primary completion30 Jun 2023 (estimated)
- Study completion31 Jul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Study the Relationship Between Insulin Resistance With Hormonal and Ovarian Morphological Characteristics in Patients With Polycystic Ovarian 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
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fatma Fathy Hafez Ismail, NewGiza University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05661565
- Sponsor's protocol ID
- 0000000
- Status last verified
- Dec 2022
- First submitted
- 14 Dec 2022
- Last updated
- 22 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation of Insulin Resistance With Hormonal and Ovarian Morphological Characteristics in Patients With Polycystic Ovarian Syndrome
- ClinicalTrials.gov ID
- NCT05661565
- Acronym / sponsor ID
- 0000000
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Jan 2023 (estimated)
- Primary completion
- 30 Jun 2023 (estimated)
- Study completion
- 31 Jul 2023 (estimated)
- First posted
- 22 Dec 2022 (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.
We designed a study to determine if ovarian volume (OV) and/or follicle number (FN) are independently associated with abnormal metabolic findings in women diagnosed with PCOS. We hypothesized that ovarian morphology but not follicle number would be associated with a significantly higher odds of hyperinsulinemia among women with PCOS.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 16 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Women with PCOS attending the outpatient clinic in Kasr Alainy Hospital in the reproductive age group (20:40 years)
Key inclusion criteria (4 listed)
- oligo-or-anovulation
- clinical and/or biochemical hyperandrogenism
- the presence of 10 or more antral follicles in one ovary and/or a maximum ovarian volume > 10cc B-reproductive age group (16:45 years) C-BMI <40
Key exclusion criteria (1 listed)
- A-age >40 years B-BMI>40 C-previous ovarian surgery D-chronic medical disorders [DM , HTN , ...]
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 |
|---|---|---|
| No interventionWe try to find an association between insulin resistance with ovarian hormonal and morphological characteristics in patients with polycystic ovarian syndrome | Other | – |
Primary outcome
Correlation between the ovarian volume and Insulin resistance
Time frame: January 2023- June 2023
Correlation between the antral follicular count and insulin resistance
Time frame: January 2023- June 2023
5 secondary outcomes
Correlation between anti-mullerian hormone values and insulin resistance
Time frame: January 2023- June 2023
Correlation between FSH values and insulin resistance
Time frame: January 2023- June 2023
Correlation between LH values and insulin resistance
Time frame: January 2023- June 2023
Correlation between body mass index and insulin resistance
Time frame: January 2023- June 2023
Correlation between hirsutism and insulin resistance
Time frame: January 2023- June 2023
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2022.
- Individual participant dataSharing planned: Undecided
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.
Questions about this trial
What is this clinical trial studying?
An observational study of Study the Relationship Between Insulin Resistance With Hormonal and Ovarian Morphological Characteristics in Patients With Polycystic Ovarian Syndrome, run by Cairo University.
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 4 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 22 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact Fatma Elhawary, MRCOG (01144597490, fatma.fathy@ngu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation between the ovarian volume and Insulin resistance (time frame: January 2023- June 2023). The study lists 2 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 22 Dec 2022.