Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06043583
Other study ID # 4-2023-0729
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date July 21, 2023
Est. completion date July 2025

Study information

Verified date September 2023
Source Yonsei University
Contact Man-Deuk Kim
Phone 82-10-8625-2197
Email mdkim@yuhs.ac
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The primary purpose of this study is to compare the therapeutic efficacy of intrauterine device and uterine artery embolization for uterine adenomyosis.


Description:

Screening - History, Physical examination - Laboratory test (Hemoglobin) / MRI - Pictorial blood loss assessment chart - Symptom/Quality of life score Intervention - Intrauterine device or uterine artery embolization - Adverse event montoring Follow-up visit #1 (1 month) - Vital signs - blood test (Hemoglobin) / Ultrasound - Adverse event monitoring Follow-up visit #2 (3 month) • MRI only for embolization patients Follow-up visit #3 (6 months) - Blood test (Hemoglobin) / Ultrasound - Pictorial blood loss assessment chart - Symptom/Quality of life score Follow-up visit #4 (12months) - Blood test (Hemoglobin) / Ultrasound - Pictorial blood loss assessment chart - Symptom/Quality of life score


Recruitment information / eligibility

Status Recruiting
Enrollment 56
Est. completion date July 2025
Est. primary completion date April 2025
Accepts healthy volunteers No
Gender Female
Age group 19 Years to 48 Years
Eligibility Inclusion Criteria: 1. Women with symptomatic fibroids (age: 19 - 48 years old) 2. Hemglobin < 12g/dL, 3. Symptoms of adenomysis (Menorrhagia, Dysmenorrhea) Exclusion Criteria: 1. Gynecologic malignancy 2. Ongoing infection or inflammation 3. Coagulopathy (platelet < 50,000 or INR > 1.5) 4. Concomitant endometriosis 5. Pregnancy

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Intrauterine device
The vagina is visually inspected to check the size and position of the uterus. The speculum is inserted into the vagina. The IUD is placed inside the uterus and then the strings are cut.
Uterine artery embolization
The right common femoral artery is punctured under ultrasound guidance and a 5F vascular sheath is inserted into the Rt common femoral artery. A 5F catheter was inserted into the internal iliac artery, and a 2.0F microcatheter is advanced into the uterine artery. Embolization is performed using polyvinyl alcohol (PVA). One third (20 mL) of a 60-mL mixture comprising 150-250-µm PVA particles was injected at the beginning of embolization into each uterine artery, followed by injection of at least two thirds (40 mL) to all (60 mL) of a mixture comprising 250-355- µm PVA particles and finally completion with 355-500- µm PVA particles. Embolization was performed until complete cessation of blood flow in the ascending uterine artery for 10 heart beats.

Locations

Country Name City State
Korea, Republic of Severance hospital Seoul

Sponsors (1)

Lead Sponsor Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary Hemoglobin level Hemoglobin as an indicator of menstrual bleeding Hemoglobin level at 6 and 12 months after each procedure
Secondary Pictorial blood loss assessment chart (PBAC) Pictorial blood loss assessment chart: a semi-quantitative method for evaluation of menstrual blood loss (>100 considered as heavy mentrual blood) 0,6,12 months
Secondary Visual analogue scale Visual analogue scale: a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" and "worst pain. 0,6,12 months
Secondary Symptom and quality of life score questionnaire Symptom and quality of life score questionnaire: a questionnaire developed to objectively assess symptom severity and quality of life in relation to uterine adenomyosis before and after procedure 0,6,12 months
Secondary Uterine volume 0,12 months
See also
  Status Clinical Trial Phase
Completed NCT04665414 - Diagnosis of Adenomyosis Using Ultrasound, Elastography and MRI
Recruiting NCT04209127 - Comparing Efficacy of Microwave vs Embolization Treatment for Adenomyosis N/A
Completed NCT05751876 - Dienogest in Perimenopausal Women With Adenomyosis
Recruiting NCT01048931 - Single-port Access Laparoscopic-assisted Vaginal Hysterectomy Phase 3
Active, not recruiting NCT06223464 - Evaluation of the Relationship Between Adenomyosis and Elastographic Properties of the Cervix
Completed NCT05419414 - The Use of Shear Wave Elastography, Transvaginal Ultrasound and Pelvic MRI in the Diagnosis of Adenomyosis N/A
Recruiting NCT05152667 - Ambispective Study to Assess the Effect of Pretreatment With a Levonorgestrel-Releasing Intrauterine System Versus Oral Progestin
Not yet recruiting NCT03654144 - Role of Dienogest in the Treatment of Patient With Symptomatic Adenomyosis Phase 4
Completed NCT01992718 - What Are we Missing? Diagnosing Uterine Adenomyosis Using Ultrasound Elastography Early Phase 1
Completed NCT02192606 - Does 3D Laparoscopy Improve Vaginal Cuff Suture Time? N/A
Recruiting NCT02495311 - The Association Between Adenomyosis/Uterine Myoma and Lower Urinary Tract Symptoms
Recruiting NCT03742843 - A Multi-omics Study of Adenomyosis
Recruiting NCT04481321 - Clinical and Molecular Study of Endometriosis and Adenomyosis
Recruiting NCT04894292 - The Effect of Adenomoyosis on Pregnancy Outcomes
Completed NCT03520439 - Evaluation of Therapeutic Effect and Safety of Mifepristone in the Treatment of Adenomyosis Phase 2/Phase 3
Recruiting NCT05937490 - Adenomyosis and ART Phase 4
Recruiting NCT06373822 - New Perspectives in Adenomyosis Pathogenesis With Epigenetic Analysis and miRNAs
Completed NCT01821001 - Vaginal Bromocriptine for Treatment of Adenomyosis Phase 1
Recruiting NCT04295109 - Comparison of the Effects of Fentanyl, Oxycodone, Butorphanol on Gastrointestinal Function N/A
Recruiting NCT04356664 - Benefit of GnRH Agonist Before Frozen Embryo Transfer in Patients With Endometriosis and/or Adenomyosis Phase 2/Phase 3