Ovarian CystsNCT05418595
Ultrasonographic Evaluation of Ovarian Stromal Vascularity in Women With Polycystic Ovary Syndrome (PCOS)
An observational study of Ovarian Cysts, run by Usak State Hospital at 1 site in Turkey (Türkiye).
Trial summary
The most common endocrine condition in reproductive women is polycystic ovary syndrome. It has a prevalence of 5-10%. According to the Rotterdam criteria, oligo/anovulation, clinic or biochemical hyperandrogenism, PCOS morphology in ultrasonography, and the presence of these two criteria are required for diagnosis. Read more about this study
- Who is it for?
- Ages 18 to 38 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Ovarian Cysts
- How many people
- 42 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 13 Jun 2022to 4 Sep 2022
- 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 38 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Reproductive period, PCOS women
Who may be able to join
- Reproductive period According to Rotterdam criteria PCOS women.
Who cannot join
- Women have not PCOS criteria, Non-reproductive period Pregnancy Postpartum Ovarian mass Underwent ovarian surgery.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ultrasonographic Evaluation of Ovarian Stroma in PCOS Women
The most common endocrine condition in reproductive women is polycystic ovary syndrome. It has a prevalence of 5-10%. According to the Rotterdam criteria, oligo/anovulation, clinic or biochemical hyperandrogenism, PCOS morphology in ultrasonography, and the presence of these two criteria are required for diagnosis.
The echogenicity of the ovarian stroma, vascularity, ovarian size, cystic pattern density, and subcortical organization of cysts are all significant considerations in ultrasonographic evaluation.
Read the detailed description
Retrospective archive study.
In the years 2018-2019, the ultrasonographic archives of PCOS women will be analyzed retrospectively in the Radiology department of Usak Education and Research Hospital. Ultrasonographic (Two-dimensional ultrasonography , conventional and other doppler) measurements of ovaries will be assessed in ultrasonographic data. Patient's data ( Menstrual cycle, androgenic findings, age, BMI etc..) will be obtained on the hospital records, PCOS patient's phenotype will be evaluated according to National Institutes Health (NIH) recommendations.
The ovarian ultrasonographic findings of PCOS women will be compared.
This study approved by Usak University Medical Faculty Ethical Committee April,06,2022.
The Ethical Committee decision number is 57-57-04.
- Conditions
- Ovarian Cysts
- Medical subject headings
- Ovarian Cysts
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Other
| Study group | Role | What they receive |
|---|---|---|
| Group-1 | PCOS patients intraovarian stromal conventional and SMI doppler findings |
What is being measured
The primary outcome is the main question the study is designed to answer.
The superiority of Superb microvascular imaging doppler technique over the conventional doppler techniques
The Toshiba Aplio 500 ultrasonography tool (Toshiba, Aplio 500, Tokyo, Japan) was used in the Radiology Policlinic Ultrasonography Unit to perform ultrasonography using a 1-6 MHz convex probe. After scanning the lesion with TAUSG, 5-12 second-long video pictures were recorded. The ovarian stromal vascularity was defined according to the International Ovarian Tumor Analysis (IOTA) group criteria. Four categories of endometrial blood flow were identified: No coloration in grade 1, one or more punctate colorations in grade 2, one linear coloring or several (>5) punctate colorations in grade 3, and multiple linear colorations in grade 4 of the ovary. [14]. The vascularization rating was done independently using CDI, PDI, cSMI, and mSMI techniques. In all patients, the ovarian morphologic features were recorded for the both ovaries. Three radiologists analyzed the captured video pictures and assigned a consensus rating.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2022
- Study start13 Jun 2022
- Primary completion4 Sep 2022
- Study completion4 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Ovarian CystsStudies 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Usak State Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Irem Senyuva, Usak State Hospital
- Investigators
- İrem Şenyuva, MD, Principal investigator, USAK TRAINING AND RESEARCH HOSPITAL, DEPARTMENT OF OBSTETRICS AND GYNECOLOGY,TURKEY
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05418595
- Sponsor's protocol ID
- 575704
- Status last verified
- Sep 2022
- First submitted
- 8 Jun 2022
- Last updated
- 21 Sep 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ozdemir O, Sari ME, Kalkan D, Koc EM, Ozdemir S, Atalay CR. Comprasion of ovarian stromal blood flow measured by color Doppler ultrasonography in polycystic ovary syndrome patients and healthy women with ultrasonographic evidence of polycystic. Gynecol Endocrinol. 2015 Apr;31(4):322-6. doi: 10.3109/09513590.2014.995617. Epub 2015 Jan 5.
PubMed 25558942Makled AK, El Sherbiny M, Elkabarity R. Assessment of ovarian stromal blood flow after metformin treatment in women with polycystic ovary syndrome. Arch Gynecol Obstet. 2014 Apr;289(4):883-91. doi: 10.1007/s00404-013-3057-8. Epub 2013 Nov 7.
PubMed 24196302
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasonographic Evaluation of Ovarian Stroma in PCOS Women
- ClinicalTrials.gov ID
- NCT05418595
- Acronym / sponsor ID
- 575704
- Conditions
- Ovarian Cysts
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Usak State HospitalUniversity, hospital or other
- Study start
- 13 Jun 2022 (actual)
- Primary completion
- 4 Sep 2022 (actual)
- Study completion
- 4 Sep 2022 (actual)
- First posted
- 14 Jun 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.
The most common endocrine condition in reproductive women is polycystic ovary syndrome. It has a prevalence of 5-10%. According to the Rotterdam criteria, oligo/anovulation, clinic or biochemical hyperandrogenism, PCOS morphology in ultrasonography, and the presence of these two criteria are required for diagnosis.
The echogenicity of the ovarian stroma, vascularity, ovarian size, cystic pattern density, and subcortical organization of cysts are all significant considerations in ultrasonographic evaluation.
Detailed description
Retrospective archive study.
In the years 2018-2019, the ultrasonographic archives of PCOS women will be analyzed retrospectively in the Radiology department of Usak Education and Research Hospital. Ultrasonographic (Two-dimensional ultrasonography , conventional and other doppler) measurements of ovaries will be assessed in ultrasonographic data. Patient's data ( Menstrual cycle, androgenic findings, age, BMI etc..) will be obtained on the hospital records, PCOS patient's phenotype will be evaluated according to National Institutes Health (NIH) recommendations.
The ovarian ultrasonographic findings of PCOS women will be compared.
This study approved by Usak University Medical Faculty Ethical Committee April,06,2022.
The Ethical Committee decision number is 57-57-04.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group-1 | – | –PCOS patients intraovarian stromal conventional and SMI doppler findings |
Who may qualify
- Ages
- 18 to 38 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Reproductive period, PCOS women
Key inclusion criteria (1 listed)
- Reproductive period According to Rotterdam criteria PCOS women.
Key exclusion criteria (1 listed)
- Women have not PCOS criteria, Non-reproductive period Pregnancy Postpartum Ovarian mass Underwent ovarian surgery.
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 |
|---|---|---|
| Other | Group-1 |
Primary outcome
The superiority of Superb microvascular imaging doppler technique over the conventional doppler techniques
Time frame: 1 month
The Toshiba Aplio 500 ultrasonography tool (Toshiba, Aplio 500, Tokyo, Japan) was used in the Radiology Policlinic Ultrasonography Unit to perform ultrasonography using a 1-6 MHz convex probe. After scanning the lesion with TAUSG, 5-12 second-long video pictures were recorded. The ovarian stromal vascularity was defined according to the International Ovarian Tumor Analysis (IOTA) group criteria. Four categories of endometrial blood flow were identified: No coloration in grade 1, one or more punctate colorations in grade 2, one linear coloring or several (>5) punctate colorations in grade 3, and multiple linear colorations in grade 4 of the ovary. [14]. The vascularization rating was done independently using CDI, PDI, cSMI, and mSMI techniques. In all patients, the ovarian morphologic features were recorded for the both ovaries. Three radiologists analyzed the captured video pictures and assigned a consensus rating.
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 21 Sep 2022.
- Background: PubMed 25558942Ozdemir O, Sari ME, Kalkan D, Koc EM, Ozdemir S, Atalay CR. Comprasion of ovarian stromal blood flow measured by color Doppler ultrasonography in polycystic ovary syndrome patients and healthy women with ultrasonographic evidence of polycystic. Gynecol Endocrinol. 2015 Apr;31(4):322-6. doi: 10.3109/09513590.2014.995617. Epub 2015 Jan 5.
- Background: PubMed 24196302Makled AK, El Sherbiny M, Elkabarity R. Assessment of ovarian stromal blood flow after metformin treatment in women with polycystic ovary syndrome. Arch Gynecol Obstet. 2014 Apr;289(4):883-91. doi: 10.1007/s00404-013-3057-8. Epub 2013 Nov 7.
- Individual participant dataSharing planned: No
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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.
İrem Şenyuva, MD principal investigator
USAK TRAINING AND RESEARCH HOSPITAL, DEPARTMENT OF OBSTETRICS AND GYNECOLOGY,TURKEY
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 Ovarian Cysts, run by Usak State Hospital at 1 site in Turkey (Türkiye).
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: finished, as of the sponsor's last update on 21 Sep 2022. 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 Turkey (Türkiye). 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?
The superiority of Superb microvascular imaging doppler technique over the conventional doppler techniques (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05418595, which also lists 2 linked publications.
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 21 Sep 2022.