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

Not Applicable

• Conditions: Ovarian Endometrioma
• Interventions: Procedure: catheter-directed sclerotherapy; Procedure: surgical resection

• Registration Number: NCT05279209
• Lead Sponsor: Yonsei University

Brief 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

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 Timeline

• Study Start: 2021-12-18
• Study First Submitted: 2022-01-11
• Status Verified: 2022-03
• Study First Submitted QC: 2022-03-14
• Last Update Submitted: 2022-03-14
• Study First Posted: 2022-03-15
• Last Update Posted: 2022-03-15
• Primary Completion: 2022-12-17
• Study Completion: 2023-12-17

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 98

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sclerotherapy	catheter-directed sclerotherapy	Patients who receive uterine artery embolization for symptomatic fibroids
Surgery	surgical resection	Patients who receive uterine artery embolization for symptomatic fibroids

Primary Outcome Measures

Name	Time	Method
Serum AMH	Serum AMH at 12 months after catheter-directed sclerotherapy	Serum AMH: A measure of ovarian function

Secondary Outcome Measures

Name	Time	Method
serum CA-125	1, 6, 12 months	Serum CA-125 (unit/mL): Surrogate marker for therapeutic efficacy (A reduction in serum CA-125 represents a response to the intervention)
hospital stay	duration of admission (days), up to 5 days	Time from admission to discharge
EHP-30 (Endometriosis Health Profile-30)	6 and 12 months	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)
Recurrence	1, 6, and 12 months	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).

Trial Locations

Locations (1)

Yonsei University Health System, Severance Hospital; 🇰🇷 Seoul, Korea, Republic of