Status:
UNKNOWN
Catheter-directed Sclerotherapy Versus Surgical Resecction: Randomized Controlled Trial Comparing Ovarian Function and Therapeutic Efficacy After Treatment of Ovarian Endometrioma
Lead Sponsor:
Yonsei University
Conditions:
Ovarian Endometrioma
Eligibility:
FEMALE
19-60 years
Phase:
NA
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 * Lab...
Eligibility Criteria
Inclusion
- 1\. Women with symptomatic fibroids (age: 20 - 60 years old)
Exclusion
- 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
Key Trial Info
Start Date :
December 18 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 17 2023
Estimated Enrollment :
98 Patients enrolled
Trial Details
Trial ID
NCT05279209
Start Date
December 18 2021
End Date
December 17 2023
Last Update
March 15 2022
Active Locations (1)
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1
Yonsei University Health System, Severance Hospital
Seoul, South Korea