Leiomyoma (Uterine Fibroids)MYO-DOPNCT07343765
Investigation of the Impact of Myomectomy on Uterine Artery Doppler Velocimetry Findings
An observational study of Leiomyoma (Uterine Fibroids) and Myomectomy, run by Bakirkoy Dr. Sadi Konuk Research and Training Hospital at 1 site in Turkey (Türkiye).
Trial summary
Objective: This scientific study aims to investigate whether myomectomy induces significant changes in uterine artery blood flow patterns. While Doppler ultrasonography is traditionally used to assess myoma vascularity, differential diagnosis (adenomyoma or sarcoma), and fertility impacts, there is a lack of… Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Leiomyoma (Uterine Fibroids), Myomectomy, Doppler Ultrasound
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2025to 27 Feb 2026
- How long will I take part?
- 40 Days
- 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 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Patients scheduled for myomectomy at the Obstetrics and Gynecology Clinic of our hospital
Who may be able to join
- Premenopausal women aged between 18 and 50 years.
- Women with uterine leiomyoma detected via ultrasonography.
- Patients referred to the Obstetrics and Gynecology department board for whom a myomectomy operation has been decided.
- Women who provide consent for transvaginal ultrasound examination.
Who cannot join
- Women under 18 years of age and postmenopausal women.
- Current pregnancy or postpartum status.
- Presence of known circulatory disorders, cardiovascular diseases, or other chronic conditions affecting blood flow.
- Smokers.
- Current use of hormonal medications (e.g., oral contraceptives, levonorgestrel-releasing intrauterine devices, etc.).
- Presence of concurrent gynecological pathologies (e.g., adenomyosis, endometriosis, ovarian cysts, or gynecological malignancies).
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
Objective: This scientific study aims to investigate whether myomectomy induces significant changes in uterine artery blood flow patterns. While Doppler ultrasonography is traditionally used to assess myoma vascularity, differential diagnosis (adenomyoma or sarcoma), and fertility impacts, there is a lack of prospective evidence comparing preoperative and postoperative uterine artery Doppler findings.
Study Design and Rationale: The study will evaluate the hemodynamic influence of myomectomy by comparing flow measurements in the main uterine artery before and after surgical intervention. Existing literature has primarily focused on the correlation between myoma volume and vascular resistance; however, the direct impact of surgical removal of a myoma on uterine artery doppler velocimetry remains under-investigated.
Read more
Participant Involvement: Participation is entirely voluntary, and participants may withdraw at any time without any impact on their medical care. Data collection involves routine clinical history, physical examination, and non-invasive ultrasound measurements.
Clinical Significance: By establishing the effect of myoma removal on uterine blood supply, this research aims to provide guiding data for the follow-up and treatment planning of patients with leiomyomas. The findings may offer new insights into how surgical management restores or alters uterine hemodynamics, potentially influencing future diagnostic and therapeutic approaches.
Read the detailed description
Uterine leiomyomas are the most common benign pelvic tumors in women and originate from the uterine smooth muscle tissue. While often asymptomatic, their size and location can cause clinical symptoms that significantly impair quality of life.
The pathogenesis of uterine leiomyoma is yet to be elucidated by the ongoing research. Our current knowledge reveals myoma pathogenesis involves a complex interplay of genetic factors, sex steroids, growth factors, extracellular matrix interactions, and angiogenesis. Understanding the mechanisms of leiomyoma pathogenesis and the interaction of myoma with adjacent myometrium is crucial to improve our management and treatment options.
Ultrasonography (USG) remains the gold standard for first-line imaging for uterine leiomyomas being highly sensitive, specific, and cost-effective. Doppler USG enables the evaluation of uterine blood flow by measuring the pulsatility index (PI), resistance index (RI), and systole/diastole (S/D) ratio. These parameters are widely used in routine obstetrics practice, where higher values indicate increased distal vascular resistance and lower values reflect enhanced perfusion and reduced impedance. Several studies observed increased blood flow in uterine artery measuring significantly lower resistance in the vessel. Our previous study revealed different doppler velocimetry findings in different leiomyoma localizations and a positive correlation between the indices and uterine operation history indicating an increased resistance in uterine artery after uterine surgery.
Myomectomy is a common procedure for cases of symptomatic leiomyoma and widely performed by gynecologists. This study aims to investigate the impact of myomectomy on uterine artery Doppler velocimetry parameters by comparing preoperative and postoperative measurements in patients diagnosed with uterine leiomyoma.
Method: This single-center, prospective clinical study will be conducted at the Bakırköy Dr. Sadi Konuk Training and Research Hospital, Department of Obstetrics and Gynecology, between August 2025 and January 2026. Following ethical approval, patients scheduled for myomectomy will be screened based on specific inclusion and exclusion criteria. Written informed consent will be obtained from all voluntary participants.
Patient data-including demographics, medical and obstetric history, presenting complaints (specifically abnormal uterine bleeding), and Visual Analog Scale (VAS) pain scores-will be recorded via the institutional electronic database (PROBEL). During routine gynecological assessment, transvaginal ultrasonography will be performed to determine myoma dimensions and localization according to the FIGO classification.
Uterine artery Doppler velocimetry findings, including the pulsatility index (PI), resistance index (RI), and systolic/diastolic (S/D) ratio, will be recorded both preoperatively and during the late postoperative period (after the 40th postoperative day). The histopathological findings will be integrated into the final analysis to confirm the diagnosis.
Statistical Analysis: Data analysis will be performed using SPSS Version 29.0.2 and G*Power 3.1.9.7.
- Conditions
- Leiomyoma (Uterine Fibroids), Myomectomy, Doppler Ultrasound
- Keywords
- leiomyoma, doppler, velocimetry, myomectomy
- Medical subject headings
- Leiomyoma
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 |
|---|---|---|
| preoperative doppler measurements | Uterine leiomyoma cases before myomectomy operation will be investegated measuring doppler indices of pulsatility index, resistance index and systolic/dyastolic ratio. | |
| postoperative doppler measurements | Uterine leiomyoma cases who had myomectomy operation will be investegated measuring doppler indices of pulsatility index, resistance index and systolic/dyastolic ratio at the late postoperative period (40 days postoperatively) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pulsatility index
Pulsatility index will be measured in bilateral uterine arteries preoperatively and postoperatively in myomectomy cases.
Measured: from the enrollment in preoperative period to the late postoperative period (40 days after operation)
resistance index
Uterine arter doppler measurement of resistance index will be measured preoperatively and postoperatively (40 days after operation) for bilateral uterine arteries.
Measured: from the enrollment in preoperative period to the late postoperative period (40 days after operation)
systolic/dyastolic ratio
Systolic/dyastolic ratio will be measured in bilateral uterine arteries preoperatively and postoperatively in myomectomy cases.
Measured: from the enrollment in preoperative period to the late postoperative period (40 days after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2026
- Study start1 Sep 2025
- Primary completion27 Feb 2026
- Study completion27 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- 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
- 50 participants (actual)
- Target duration
- 40 Days
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
- Investigators
- ilke esin aydıner, Principal investigator, Bakırköy Sadi Konuk
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07343765
- Sponsor's protocol ID
- 2025/276
- Acronym
- MYO-DOP
- Status last verified
- Jan 2026
- First submitted
- 7 Jan 2026
- Last updated
- 8 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: It has personal data of our participants and there is no consent of the participants regarding the sharing.
Publications
Giuliani E, As-Sanie S, Marsh EE. Epidemiology and management of uterine fibroids. Int J Gynaecol Obstet. 2020 Apr;149(1):3-9. doi: 10.1002/ijgo.13102. Epub 2020 Feb 17.
PubMed 31960950Ciarmela P, Delli Carpini G, Greco S, Zannotti A, Montik N, Giannella L, Giuliani L, Grelloni C, Panfoli F, Paolucci M, Pierucci G, Ragno F, Pellegrino P, Petraglia F, Ciavattini A. Uterine fibroid vascularization: from morphological evidence to clinical implications. Reprod Biomed Online. 2022 Feb;44(2):281-294. doi: 10.1016/j.rbmo.2021.09.005. Epub 2021 Sep 20.
PubMed 34848152Idowu BM, Ibitoye BO, Adetiloye VA. Uterine Artery Doppler Velocimetry of Uterine Leiomyomas in Nigerian Women. Rev Bras Ginecol Obstet. 2017 Sep;39(9):464-470. doi: 10.1055/s-0037-1604489. Epub 2017 Aug 7.
PubMed 28783853Tal R, Segars JH. The role of angiogenic factors in fibroid pathogenesis: potential implications for future therapy. Hum Reprod Update. 2014 Mar-Apr;20(2):194-216. doi: 10.1093/humupd/dmt042. Epub 2013 Sep 29.
PubMed 24077979
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Impact of Myomectomy on Uterine Artery Doppler Velocimetry Findings
- ClinicalTrials.gov ID
- NCT07343765
- Acronym / sponsor ID
- MYO-DOP / 2025/276
- Conditions
- Leiomyoma (Uterine Fibroids), Myomectomy, Doppler Ultrasound
- Keywords
- leiomyoma, doppler, velocimetry, myomectomy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Bakirkoy Dr. Sadi Konuk Research and Training HospitalOther government
- Study start
- 1 Sep 2025 (actual)
- Primary completion
- 27 Feb 2026 (actual)
- Study completion
- 27 Feb 2026 (actual)
- First posted
- 15 Jan 2026 (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.
Objective: This scientific study aims to investigate whether myomectomy induces significant changes in uterine artery blood flow patterns. While Doppler ultrasonography is traditionally used to assess myoma vascularity, differential diagnosis (adenomyoma or sarcoma), and fertility impacts, there is a lack of prospective evidence comparing preoperative and postoperative uterine artery Doppler findings.
Study Design and Rationale: The study will evaluate the hemodynamic influence of myomectomy by comparing flow measurements in the main uterine artery before and after surgical intervention. Existing literature has primarily focused on the correlation between myoma volume and vascular resistance; however, the direct impact of surgical removal of a myoma on uterine artery doppler velocimetry remains under-investigated.
Participant Involvement: Participation is entirely voluntary, and participants may withdraw at any time without any impact on their medical care. Data collection involves routine clinical history, physical examination, and non-invasive ultrasound measurements.
Clinical Significance: By establishing the effect of myoma removal on uterine blood supply, this research aims to provide guiding data for the follow-up and treatment planning of patients with leiomyomas. The findings may offer new insights into how surgical management restores or alters uterine hemodynamics, potentially influencing future diagnostic and therapeutic approaches.
Detailed description
Uterine leiomyomas are the most common benign pelvic tumors in women and originate from the uterine smooth muscle tissue. While often asymptomatic, their size and location can cause clinical symptoms that significantly impair quality of life.
The pathogenesis of uterine leiomyoma is yet to be elucidated by the ongoing research. Our current knowledge reveals myoma pathogenesis involves a complex interplay of genetic factors, sex steroids, growth factors, extracellular matrix interactions, and angiogenesis. Understanding the mechanisms of leiomyoma pathogenesis and the interaction of myoma with adjacent myometrium is crucial to improve our management and treatment options.
Ultrasonography (USG) remains the gold standard for first-line imaging for uterine leiomyomas being highly sensitive, specific, and cost-effective. Doppler USG enables the evaluation of uterine blood flow by measuring the pulsatility index (PI), resistance index (RI), and systole/diastole (S/D) ratio. These parameters are widely used in routine obstetrics practice, where higher values indicate increased distal vascular resistance and lower values reflect enhanced perfusion and reduced impedance. Several studies observed increased blood flow in uterine artery measuring significantly lower resistance in the vessel. Our previous study revealed different doppler velocimetry findings in different leiomyoma localizations and a positive correlation between the indices and uterine operation history indicating an increased resistance in uterine artery after uterine surgery.
Myomectomy is a common procedure for cases of symptomatic leiomyoma and widely performed by gynecologists. This study aims to investigate the impact of myomectomy on uterine artery Doppler velocimetry parameters by comparing preoperative and postoperative measurements in patients diagnosed with uterine leiomyoma.
Method: This single-center, prospective clinical study will be conducted at the Bakırköy Dr. Sadi Konuk Training and Research Hospital, Department of Obstetrics and Gynecology, between August 2025 and January 2026. Following ethical approval, patients scheduled for myomectomy will be screened based on specific inclusion and exclusion criteria. Written informed consent will be obtained from all voluntary participants.
Patient data-including demographics, medical and obstetric history, presenting complaints (specifically abnormal uterine bleeding), and Visual Analog Scale (VAS) pain scores-will be recorded via the institutional electronic database (PROBEL). During routine gynecological assessment, transvaginal ultrasonography will be performed to determine myoma dimensions and localization according to the FIGO classification.
Uterine artery Doppler velocimetry findings, including the pulsatility index (PI), resistance index (RI), and systolic/diastolic (S/D) ratio, will be recorded both preoperatively and during the late postoperative period (after the 40th postoperative day). The histopathological findings will be integrated into the final analysis to confirm the diagnosis.
Statistical Analysis: Data analysis will be performed using SPSS Version 29.0.2 and G*Power 3.1.9.7.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 40 Days
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| preoperative doppler measurements | – | –Uterine leiomyoma cases before myomectomy operation will be investegated measuring doppler indices of pulsatility index, resistance index and systolic/dyastolic ratio. |
| postoperative doppler measurements | – | –Uterine leiomyoma cases who had myomectomy operation will be investegated measuring doppler indices of pulsatility index, resistance index and systolic/dyastolic ratio at the late postoperative period (40 days postoperatively) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients scheduled for myomectomy at the Obstetrics and Gynecology Clinic of our hospital
Key inclusion criteria (4 listed)
- Premenopausal women aged between 18 and 50 years.
- Women with uterine leiomyoma detected via ultrasonography.
- Patients referred to the Obstetrics and Gynecology department board for whom a myomectomy operation has been decided.
- Women who provide consent for transvaginal ultrasound examination.
Key exclusion criteria (6 listed)
- Women under 18 years of age and postmenopausal women.
- Current pregnancy or postpartum status.
- Presence of known circulatory disorders, cardiovascular diseases, or other chronic conditions affecting blood flow.
- Smokers.
- Current use of hormonal medications (e.g., oral contraceptives, levonorgestrel-releasing intrauterine devices, etc.).
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
Pulsatility index
Time frame: from the enrollment in preoperative period to the late postoperative period (40 days after operation)
Pulsatility index will be measured in bilateral uterine arteries preoperatively and postoperatively in myomectomy cases.
resistance index
Time frame: from the enrollment in preoperative period to the late postoperative period (40 days after operation)
Uterine arter doppler measurement of resistance index will be measured preoperatively and postoperatively (40 days after operation) for bilateral uterine arteries.
systolic/dyastolic ratio
Time frame: from the enrollment in preoperative period to the late postoperative period (40 days after operation
Systolic/dyastolic ratio will be measured in bilateral uterine arteries preoperatively and postoperatively in myomectomy cases.
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 8 Oct 2026.
- Background: PubMed 31960950Giuliani E, As-Sanie S, Marsh EE. Epidemiology and management of uterine fibroids. Int J Gynaecol Obstet. 2020 Apr;149(1):3-9. doi: 10.1002/ijgo.13102. Epub 2020 Feb 17.
- Background: PubMed 34848152Ciarmela P, Delli Carpini G, Greco S, Zannotti A, Montik N, Giannella L, Giuliani L, Grelloni C, Panfoli F, Paolucci M, Pierucci G, Ragno F, Pellegrino P, Petraglia F, Ciavattini A. Uterine fibroid vascularization: from morphological evidence to clinical implications. Reprod Biomed Online. 2022 Feb;44(2):281-294. doi: 10.1016/j.rbmo.2021.09.005. Epub 2021 Sep 20.
- Background: PubMed 28783853Idowu BM, Ibitoye BO, Adetiloye VA. Uterine Artery Doppler Velocimetry of Uterine Leiomyomas in Nigerian Women. Rev Bras Ginecol Obstet. 2017 Sep;39(9):464-470. doi: 10.1055/s-0037-1604489. Epub 2017 Aug 7.
- Background: PubMed 24077979Tal R, Segars JH. The role of angiogenic factors in fibroid pathogenesis: potential implications for future therapy. Hum Reprod Update. 2014 Mar-Apr;20(2):194-216. doi: 10.1093/humupd/dmt042. Epub 2013 Sep 29.
- Individual participant dataSharing planned: No. It has personal data of our participants and there is no consent of the participants regarding the sharing.
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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.
ilke esin aydıner principal investigator
Bakırköy Sadi Konuk
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) and Myomectomy, 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 4 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 8 Oct 2026. 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?
Pulsatility index (time frame: from the enrollment in preoperative period to the late postoperative period (40 days after operation)). 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?
On the ClinicalTrials.gov record for NCT07343765, which also lists 4 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 8 Oct 2026.