Investigation of the Impact of Myomectomy on Uterine Artery Doppler Velocimetry Findings (MYO-DOP)

January 7, 2026 updated by: İlke Esin Aydıner, Bakirkoy Dr. Sadi Konuk Research and Training Hospital

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.

Study Overview

Status

Enrolling by invitation

Conditions

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 Type

Observational

Enrollment (Estimated)

70

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey (Türkiye)
    • bakırköy
      • Istanbul, bakırköy, Turkey (Türkiye), 34147
        • Bakırköy Dr Sadi Konuk Eğitim ve Araştırma Hastanesi

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients scheduled for myomectomy at the Obstetrics and Gynecology Clinic of our hospital

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
from the enrollment in preoperative period to the late postoperative period (40 days after operation)
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.
from the enrollment in preoperative period to the late postoperative period (40 days after operation)
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.
from the enrollment in preoperative period to the late postoperative period (40 days after operation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bakirkoy Dr. Sadi Konuk Research and Training Hospital

Investigators

  • Principal Investigator: ilke esin aydıner, Bakırköy Sadi Konuk

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2025

Primary Completion (Estimated)

February 1, 2026

Study Completion (Estimated)

February 1, 2026

Study Registration Dates

First Submitted

January 7, 2026

First Submitted That Met QC Criteria

January 7, 2026

First Posted (Actual)

January 15, 2026

Study Record Updates

Last Update Posted (Actual)

January 15, 2026

Last Update Submitted That Met QC Criteria

January 7, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2025/276

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

It has personal data of our participants and there is no consent of the participants regarding the sharing.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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