Catheter-directed Sclerotherapy Versus Surgical Resecction: Randomized Controlled Trial Comparing Ovarian Function and Therapeutic Efficacy After Treatment of Ovarian Endometrioma

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

Study Overview

• Status: Recruiting
• Conditions: Ovarian Endometrioma
• Intervention / Treatment: Procedure: catheter-directed sclerotherapy; Procedure: surgical resection

Detailed 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

• Study Type: Interventional
• Enrollment (Anticipated): 98
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kichang Han; Phone Number: 82-10-9722-6315; Email: wowsaycheese@yuhs.ac

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Recruiting
    • Yonsei University Health System, Severance Hospital
    • Contact: Kichang Han; Phone Number: 82-10-9722-6315; Email: wowsaycheese@yuhs.ac

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sclerotherapy; Patients who receive uterine artery embolization for symptomatic fibroids	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.
Active Comparator: Surgery; Patients who receive uterine artery embolization for symptomatic fibroids	Procedure: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Serum AMH	Serum AMH: A measure of ovarian function	Serum AMH at 1month after catheter-directed sclerotherapy
Serum AMH	Serum AMH: A measure of ovarian function	Serum AMH at 6months after catheter-directed sclerotherapy
Serum AMH	Serum AMH: A measure of ovarian function	Serum AMH at 12 months after catheter-directed sclerotherapy

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
hospital stay	Time from admission to discharge	duration of admission (days), up to 5 days
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
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

Collaborators and Investigators

• Sponsor: Yonsei University

Study record dates

Study Major Dates

• Study Start (Actual): December 18, 2021
• Primary Completion (Anticipated): December 17, 2022
• Study Completion (Anticipated): December 17, 2023

Study Registration Dates

• First Submitted: January 11, 2022
• First Submitted That Met QC Criteria: March 14, 2022
• First Posted (Actual): March 15, 2022

Study Record Updates

• Last Update Posted (Actual): March 15, 2022
• Last Update Submitted That Met QC Criteria: March 14, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: sclerotherapy; resection; ovarian function; Endometrioma; enucleation
• Additional Relevant MeSH Terms: Endometriosis
• Other Study ID Numbers: 4-2021-1512

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No