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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05279209
Other study ID # 4-2021-1512
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date December 18, 2021
Est. completion date December 17, 2023

Study information

Verified date March 2022
Source Yonsei University
Contact Kichang Han
Phone 82-10-9722-6315
Email wowsaycheese@yuhs.ac
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The primary purpose of this study is to compare residual ovarian function and therapeutic efficacy of surgical resection and catheter-directed sclerotherapy for ovarian endometrioma


Description:

Screening - History, Physical examination - Vital signs - Laboratory test (Serum AMH, CA-125, HE-4) / EKG / MRI - EHP-30 Intervention - Surgical enucleation or catheter-directed sclerotherapy - Laboratory test / EKG - Adverse event monitoring Follow-up visit #1 (1 month) - Vital signs - Lab test (AMH, CA-125) / Ultrasound - Adverse event monitoring Follow-up visit #2 (6 months) - Vital signs - Lab test (AMH, CA-125) / Ultrasound / Contrast-enhanced MRI - EHP-30 Follow-up visit #3 (12months) - Vital signs - Lab test (AMH, CA-125) / Ultrasound - EHP-30


Recruitment information / eligibility

Status Recruiting
Enrollment 98
Est. completion date December 17, 2023
Est. primary completion date December 17, 2022
Accepts healthy volunteers No
Gender Female
Age group 19 Years to 60 Years
Eligibility Inclusion Criteria: 1. Women with symptomatic fibroids (age: 20 - 60 years old) Exclusion Criteria: 1. Gynecologic malignancy 2. Ongoing infection or inflammation 3. Coagulopathy (platelet < 50,000 or INR > 1.5) 4. Extraovarian endometriosis 5. Serum AMH of 5 or higher 6. Drug allergy 7. Illiteracy 8. Pregnancy

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
catheter-directed sclerotherapy
Ovarian endometrioma is targeted under transvaginal/transabdominal ultrasound. A guidewire is inserted to the lesion and is exchanged for a catheter. The cystic content is thoroughly aspirated and then sclerotherapy is performed by injecting 99% ethanol.
surgical resection
Surgical resection of the ovarian endometrioma is performed under general anesthesia. To preserve the residual ovarian function, enucleation is the primary surgical technique.

Locations

Country Name City State
Korea, Republic of Yonsei University Health System, 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 Serum AMH Serum AMH: A measure of ovarian function Serum AMH at 1month after catheter-directed sclerotherapy
Primary Serum AMH Serum AMH: A measure of ovarian function Serum AMH at 6months after catheter-directed sclerotherapy
Primary Serum AMH Serum AMH: A measure of ovarian function Serum AMH at 12 months after catheter-directed sclerotherapy
Secondary Recurrence Recurrence of symptoms or development of ovarian endometrioma of 2cm or larger on follow-up imaging (surgery) vs. Recurrence of symptoms or detection of the lesion 50% or larger to the size of the initial lesion on follow-up imaging (sclerotherapy). 1, 6, and 12 months
Secondary hospital stay Time from admission to discharge duration of admission (days), up to 5 days
Secondary serum CA-125 Serum CA-125 (unit/mL): Surrogate marker for therapeutic efficacy (A reduction in serum CA-125 represents a response to the intervention) 1, 6, 12 months
Secondary EHP-30 (Endometriosis Health Profile-30) EHP-30: A measure of quality of life related to ovarian endometrioma (Scale of 0 to 30, A higher score represents adverse impact of daily living by the endometriosis) 6 and 12 months
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