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

Yonsei University

Status: Unknown

Conditions: Ovarian Endometrioma

Treatments: Procedure: surgical resection; Procedure: catheter-directed sclerotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT05279209

4-2021-1512

Details and patient eligibility

About

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

Full 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

Enrollment: 98 estimated patients

Sex: Female

Ages: 19 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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98 participants in 2 patient groups

Sclerotherapy

Experimental group

Description:

Patients who receive uterine artery embolization for symptomatic fibroids

Treatment:

Procedure: catheter-directed sclerotherapy

Surgery

Active Comparator group

Description:

Patients who receive uterine artery embolization for symptomatic fibroids

Treatment:

Procedure: surgical resection