Catheter-directed Sclerotherapy Versus Surgical Resecction: Randomized Controlled Trial Comparing Ovarian Function and Therapeutic Efficacy After Treatment of Ovarian Endometrioma
NCT ID: NCT05279209
Last Updated: 2022-03-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
98 participants
INTERVENTIONAL
2021-12-18
2023-12-17
Brief Summary
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Detailed Description
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* 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
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Sclerotherapy
Patients who receive uterine artery embolization for symptomatic fibroids
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.
Surgery
Patients who receive uterine artery embolization for symptomatic fibroids
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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
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
19 Years
60 Years
FEMALE
No
Sponsors
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Yonsei University
OTHER
Responsible Party
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Locations
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Yonsei University Health System, Severance Hospital
Seoul, , South Korea
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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4-2021-1512
Identifier Type: -
Identifier Source: org_study_id
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