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

Study Overview
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Brief Summary
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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
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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

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

Conditions
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Ovarian Endometrioma

Intervention / Treatment
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* Procedure: catheter-directed sclerotherapy
* Procedure: surgical resection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 1. Women with symptomatic fibroids (age: 20 - 60 years old) Exclusion Criteria: Gynecologic malignancy Ongoing infection or inflammation Coagulopathy (platelet < 50,000 or INR > 1.5) Extraovarian endometriosis Serum AMH of 5 or higher Drug allergy Illiteracy Pregnancy

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sclerotherapy<br>Patients who receive uterine artery embolization for symptomatic fibroids | Procedure: catheter-directed sclerotherapy<br>* 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.<br>|
| Active Comparator: Surgery<br>Patients who receive uterine artery embolization for symptomatic fibroids | Procedure: surgical resection<br>* Surgical resection of the ovarian endometrioma is performed under general anesthesia. To preserve the residual ovarian function, enucleation is the primary surgical technique.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Endometrioma, resection, enucleation, sclerotherapy, ovarian function