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 * 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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
98
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 of the ovarian endometrioma is performed under general anesthesia. To preserve the residual ovarian function, enucleation is the primary surgical technique.
Yonsei University Health System, Severance Hospital
Seoul, South Korea
RECRUITINGSerum AMH
Serum AMH: A measure of ovarian function
Time frame: Serum AMH at 1month after catheter-directed sclerotherapy
Serum AMH
Serum AMH: A measure of ovarian function
Time frame: Serum AMH at 6months after catheter-directed sclerotherapy
Serum AMH
Serum AMH: A measure of ovarian function
Time frame: Serum AMH at 12 months after catheter-directed sclerotherapy
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).
Time frame: 1, 6, and 12 months
hospital stay
Time from admission to discharge
Time frame: 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)
Time frame: 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)
Time frame: 6 and 12 months
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