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

Ovarian Endometrioma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05279209
• Other study ID #: 4-2021-1512
• Status: Recruiting
• Phase: N/A
• Start date: December 18, 2021
• Est. completion date: December 17, 2023

Study information

• Verified date: March 2022
• Source: Yonsei University
• Contact: Kichang Han
• Phone: 82-10-9722-6315
• Email: wowsaycheese[@]yuhs.ac
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 98
• Est. completion date: December 17, 2023
• Est. primary completion date: December 17, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 19 Years to 60 Years

Eligibility

Inclusion Criteria:

1. Women with symptomatic fibroids (age: 20 - 60 years old)

Exclusion Criteria:

1. Gynecologic malignancy

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

Related Conditions & MeSH terms

• Endometriosis
• Ovarian Endometrioma

Intervention

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.
• 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.

Locations

Country	Name	City	State
Korea, Republic of	Yonsei University Health System, Severance Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serum AMH	Serum AMH: A measure of ovarian function	Serum AMH at 1month after catheter-directed sclerotherapy
Primary	Serum AMH	Serum AMH: A measure of ovarian function	Serum AMH at 6months after catheter-directed sclerotherapy
Primary	Serum AMH	Serum AMH: A measure of ovarian function	Serum AMH at 12 months after catheter-directed sclerotherapy
Secondary	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
Secondary	hospital stay	Time from admission to discharge	duration of admission (days), up to 5 days
Secondary	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
Secondary	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