NCT05279209

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 98 (estimated)
• Sponsor: Yonsei University · Academic / Other
• Sex: Female
• Age: 19 Years – 60 Years
• Healthy volunteers: Not accepted

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 * 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

• Ovarian Endometrioma

Interventions

Type	Name	Description
PROCEDURE	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.
PROCEDURE	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.

Timeline

• Start date: 2021-12-18
• Primary completion: 2022-12-17
• Completion: 2023-12-17
• First posted: 2022-03-15
• Last updated: 2022-03-15

Locations

1 site across 1 country: South Korea