Leiomyoma (Uterine Fibroids)ULLADSNCT07186257
Impact of Uterine Leiomyoma Location on Uterine Artery Doppler Velocimetry
An observational study of Leiomyoma (Uterine Fibroids), run by Bakirkoy Dr. Sadi Konuk Research and Training Hospital at 1 site in Turkey (Türkiye).
Trial summary
Aim: Investigation of the impact of uterine leiomyoma location on uterine artery velocimetry Materials and Methods: It is a single-center prospective cohort study. The information regarding patients' demography, medical history, obstetric history, menstrual patterns, gynecological history, patients' complaints and… Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Leiomyoma (Uterine Fibroids)
- How many people
- 185 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Oct 2024to 4 Jun 2025
- 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: patients who have appointments for the outpatient clinic of the hospital
Who may be able to join
- being older than 18 years old
- accepting the transvaginal ultrasound examination and having no impediment of having transvaginal ultrasound examination
- premenopausal status
- giving verbal and written consent to enroll
- being in the follicular phase of the menstrual cycle
Who cannot join
- being younger than 18 years old
- pregnancy or postpartum status
- postmenopausal status
- being virgin
- not accepting the transvaginal ultrasound examination or having an impeding condition
- having a disease causing circulaiton abnormalities, cardiac diseases, or other comorbidities effecting circulation
Show all 13Show fewer
- diagnosed diabetes
- taking any of the hormonal drugs (such as oral contraceptives, levonorgestrel realisng intrauterine devices)
- diagnosed with any other gyneoclogical pathologies ( adenomyosis, endometriosis, adnexial masses, gynecologic malignancies, pelvic inflammatory diseases etc. )
- being in the phases of menstrual cycle other than follicular phase
- diagnosis with type 2-5 and type 8 leiomyoma uteri according to the FIGO classification
- having multiple uterine leiomyomas
- having a uterine leiomyoma larger than 500cm3
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Bakırköy Dr Sadi Konuk Eğitim ve Araştırma Hastanesi
Istanbul, bakırköy, 34147
About this study
Official title: Impact of Uterine Leiomyoma Location on Uterine Artery Doppler Velocimetry : a Prospective Cohort Study
Aim: Investigation of the impact of uterine leiomyoma location on uterine artery velocimetry Materials and Methods: It is a single-center prospective cohort study. The information regarding patients' demography, medical history, obstetric history, menstrual patterns, gynecological history, patients' complaints and physical examination recorded. For the patients who experience pain, visual analog scores were recorded. Total number of 185 patients have been administered for this study. They are further divided into four sub-groups according to the leiomyoma location. All measurements were recorded by the same doppler ultrasonography machine and same preset settings were used for each measurement. All examinations were performed by the same investigator. The measurements of uterus and myoma in ortogonal projections were recorded to calculate the volume by the prolate elipsoid formula. The location of each myoma were noted according to the FIGO classification. The recorded doppler ultrasonography indices included pulsatility index, resistance index and sistol/diastol ratio. IBM SPSS 27.0.0 was used for statistical analysis.
Results: Mean values of PI, RI and S/D ratio were significantly lower in intramural myoma subgroup (p<0,01). The doppler parameters were significantly higher for submucousal myoma compared to intramural and subserous myoma groups (p<0,01) while there was no significant difference with control group. The impact of uterin leiomyoma location on uterin arter doppler findings were not altered by the effects of demographical features, age, BMI or history of c-section. The increased volumes of both uterus and myoma negatively correlated with the doppler indices while the history of c-section had a positive correlation with the doppler findings. The complaints of the patients at admission showed no effect on the doppler parameters.
Conclusion: The uterin leiomyoma location has been showed to be significant factor on uterin doppler velocimetry. The leiomyomas with intramural component significantly decreased the resistance in uterine artery. Further research is required to fully understand the underlying mechanism.
- Conditions
- Leiomyoma (Uterine Fibroids)
- Keywords
- leiomyoma, uterine artery, doppler ultrasound, doppler velocimetry, uterine leiomyoma, leiomyoma location
- Medical subject headings
- Leiomyoma, Myofibroma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| submucous leiomyoma | patients who are diagnosed with submucous leiomyoma | |
| intramural leiomyoma | patients who are diagnosed with intramural leiomyoma | |
| subserous leiomyoma | patients who are diagnosed with subserous leiomyoma | |
| control | patients in the control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
the impact of uterine leiomyom location on uterine artery pulsatility index (PI)
The pulsatility index (PI) measurements compared amongst the study groups of different leiomyoma localizations (submucous, intramural, subserous) and control group
Measured: The doppler measurement is performed at the enrollment of the first patient up to one year
the impact of uterine leiomyom location on uterine artery resistance index (RI)
The resistance index (RI) measurements compared amongst the study groups of different leiomyoma localizations (submucous, intramural, subserous) and control group
Measured: The doppler measurement is performed at the enrollment of the first patient up to one year
the impact of uterine leiomyom location on uterine artery systolic/diastolic ratio (S/D)
The systolic/diastolic ratio measurements compared amongst the study groups of different leiomyoma localizations (submucous, intramural, subserous) and control group
Measured: The doppler measurement is performed at the enrollment of the first patient up to one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2025
- Study start1 Oct 2024
- Primary completion1 May 2025
- Study completion4 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Leiomyoma (Uterine Fibroids)Studies 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
- Prospective
- Enrolment
- 185 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bakirkoy Dr. Sadi Konuk Research and Training Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, İlke Esin Aydıner, Bakirkoy Dr. Sadi Konuk Research and Training Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07186257
- Sponsor's protocol ID
- 2024-11-17
- Acronym
- ULLADS
- Status last verified
- Jun 2025
- First submitted
- 10 Jun 2025
- Last updated
- 22 Sep 2025
- Results posted
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Uterine Leiomyoma Location on Uterine Artery Doppler Velocimetry : a Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT07186257
- Acronym / sponsor ID
- ULLADS / 2024-11-17
- Conditions
- Leiomyoma (Uterine Fibroids)
- Keywords
- leiomyoma, uterine artery, doppler ultrasound, doppler velocimetry, uterine leiomyoma, leiomyoma location
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 185 participants (actual)
- Lead sponsor
- Bakirkoy Dr. Sadi Konuk Research and Training HospitalOther government
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- 1 May 2025 (actual)
- Study completion
- 4 Jun 2025 (actual)
- First posted
- 22 Sep 2025 (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.
Aim: Investigation of the impact of uterine leiomyoma location on uterine artery velocimetry Materials and Methods: It is a single-center prospective cohort study. The information regarding patients' demography, medical history, obstetric history, menstrual patterns, gynecological history, patients' complaints and physical examination recorded. For the patients who experience pain, visual analog scores were recorded. Total number of 185 patients have been administered for this study. They are further divided into four sub-groups according to the leiomyoma location. All measurements were recorded by the same doppler ultrasonography machine and same preset settings were used for each measurement. All examinations were performed by the same investigator. The measurements of uterus and myoma in ortogonal projections were recorded to calculate the volume by the prolate elipsoid formula. The location of each myoma were noted according to the FIGO classification. The recorded doppler ultrasonography indices included pulsatility index, resistance index and sistol/diastol ratio. IBM SPSS 27.0.0 was used for statistical analysis.
Results: Mean values of PI, RI and S/D ratio were significantly lower in intramural myoma subgroup (p<0,01). The doppler parameters were significantly higher for submucousal myoma compared to intramural and subserous myoma groups (p<0,01) while there was no significant difference with control group. The impact of uterin leiomyoma location on uterin arter doppler findings were not altered by the effects of demographical features, age, BMI or history of c-section. The increased volumes of both uterus and myoma negatively correlated with the doppler indices while the history of c-section had a positive correlation with the doppler findings. The complaints of the patients at admission showed no effect on the doppler parameters.
Conclusion: The uterin leiomyoma location has been showed to be significant factor on uterin doppler velocimetry. The leiomyomas with intramural component significantly decreased the resistance in uterine artery. Further research is required to fully understand the underlying mechanism.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| submucous leiomyoma | – | –patients who are diagnosed with submucous leiomyoma |
| intramural leiomyoma | – | –patients who are diagnosed with intramural leiomyoma |
| subserous leiomyoma | – | –patients who are diagnosed with subserous leiomyoma |
| control | – | –patients in the control group |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- patients who have appointments for the outpatient clinic of the hospital
Key inclusion criteria (5 listed)
- being older than 18 years old
- accepting the transvaginal ultrasound examination and having no impediment of having transvaginal ultrasound examination
- premenopausal status
- giving verbal and written consent to enroll
- being in the follicular phase of the menstrual cycle
Key exclusion criteria (13 listed)
- being younger than 18 years old
- pregnancy or postpartum status
- postmenopausal status
- being virgin
- not accepting the transvaginal ultrasound examination or having an impeding condition
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
the impact of uterine leiomyom location on uterine artery pulsatility index (PI)
Time frame: The doppler measurement is performed at the enrollment of the first patient up to one year
The pulsatility index (PI) measurements compared amongst the study groups of different leiomyoma localizations (submucous, intramural, subserous) and control group
the impact of uterine leiomyom location on uterine artery resistance index (RI)
Time frame: The doppler measurement is performed at the enrollment of the first patient up to one year
The resistance index (RI) measurements compared amongst the study groups of different leiomyoma localizations (submucous, intramural, subserous) and control group
the impact of uterine leiomyom location on uterine artery systolic/diastolic ratio (S/D)
Time frame: The doppler measurement is performed at the enrollment of the first patient up to one year
The systolic/diastolic ratio measurements compared amongst the study groups of different leiomyoma localizations (submucous, intramural, subserous) and control group
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 22 Sep 2025.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Leiomyoma (Uterine Fibroids), run by Bakirkoy Dr. Sadi Konuk Research and Training 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 5 inclusion and 13 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 22 Sep 2025. 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 impact of uterine leiomyom location on uterine artery pulsatility index (PI) (time frame: The doppler measurement is performed at the enrollment of the first patient up to one year). The study lists 3 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 Sep 2025.