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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
Screening
Intervention
Follow-up visit #1 (1 month)
Follow-up visit #2 (6 months)
Follow-up visit #3 (12months)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sclerotherapy | Experimental | Patients who receive uterine artery embolization for symptomatic fibroids |
|
| Surgery | Active Comparator | Patients who receive uterine artery embolization for symptomatic fibroids |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| catheter-directed sclerotherapy | Procedure | 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. |
| 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 |
| 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 |
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Inclusion Criteria:
1. Women with symptomatic fibroids (age: 20 - 60 years old)
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kichang Han | Contact | 82-10-9722-6315 | wowsaycheese@yuhs.ac |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yonsei University Health System, Severance Hospital | Recruiting | Seoul | South Korea |
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|
| surgical resection | Procedure | Surgical resection of the ovarian endometrioma is performed under general anesthesia. To preserve the residual ovarian function, enucleation is the primary surgical technique. |
|
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 |
| ID | Term |
|---|---|
| D004715 | Endometriosis |
| ID | Term |
|---|---|
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
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