Investigation of the Impact of Myomectomy on Uterine Artery Doppler Velocimetry Findings

NCT07343765 | Enrolling By Invitation

• 1 other identifier: 2025/276
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Leiomyoma (Uterine Fibroids); Myomectomy; Doppler Ultrasound

Keywords

leiomyoma; doppler; velocimetry; myomectomy

Outcome Measures

Primary Outcomes (3)

• Pulsatility index

  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

  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

  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

Study Arms (2)

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)

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Patients with uterus and uterine leiomyoma are enrolled.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Bakirkoy Dr. Sadi Konuk Research and Training Hospital: lead

Study Sites (1)

Bakırköy Dr Sadi Konuk Eğitim ve Araştırma Hastanesi

Istanbul, bakırköy, 34147, Turkey (Türkiye)

Location

Related Publications (4)

• 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.

  PMID: 31960950 BACKGROUND

• Ciarmela 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.

  PMID: 34848152 BACKGROUND

• Idowu 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.

  PMID: 28783853 BACKGROUND

• Tal 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.

  PMID: 24077979 BACKGROUND

MeSH Terms

Conditions

Leiomyoma

Condition Hierarchy (Ancestors)

Neoplasms, Muscle Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms

Study Officials

• ilke esin aydıner

  Bakırköy Sadi Konuk

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 40 Days
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D.

Study Record Dates

• First Submitted: January 7, 2026
• First Posted: January 15, 2026
• Study Start: September 1, 2025
• Primary Completion: February 1, 2026
• Study Completion: February 1, 2026
• Last Updated: January 15, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)