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

Primary Purpose

Ovarian Endometrioma

Status
Recruiting
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
catheter-directed sclerotherapy
surgical resection
Sponsored by
Yonsei University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ovarian Endometrioma focused on measuring Endometrioma, resection, enucleation, sclerotherapy, ovarian function

Eligibility Criteria

19 Years - 60 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Yonsei University Health System, Severance HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Sclerotherapy

Surgery

Arm Description

Patients who receive uterine artery embolization for symptomatic fibroids

Patients who receive uterine artery embolization for symptomatic fibroids

Outcomes

Primary Outcome Measures

Serum AMH
Serum AMH: A measure of ovarian function
Serum AMH
Serum AMH: A measure of ovarian function
Serum AMH
Serum AMH: A measure of ovarian function

Secondary Outcome Measures

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).
hospital stay
Time from admission to discharge
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)
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)

Full Information

First Posted
January 11, 2022
Last Updated
March 14, 2022
Sponsor
Yonsei University
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1. Study Identification

Unique Protocol Identification Number
NCT05279209
Brief Title
Catheter-directed Sclerotherapy Versus Surgical Resecction: Randomized Controlled Trial Comparing Ovarian Function and Therapeutic Efficacy After Treatment of Ovarian Endometrioma
Official Title
Catheter-directed Sclerotherapy Versus Surgical Resecction: Randomized Controlled Trial Comparing Ovarian Function and Therapeutic Efficacy After Treatment of Ovarian Endometrioma
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Recruiting
Study Start Date
December 18, 2021 (Actual)
Primary Completion Date
December 17, 2022 (Anticipated)
Study Completion Date
December 17, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yonsei University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ovarian Endometrioma
Keywords
Endometrioma, resection, enucleation, sclerotherapy, ovarian function

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
98 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Sclerotherapy
Arm Type
Experimental
Arm Description
Patients who receive uterine artery embolization for symptomatic fibroids
Arm Title
Surgery
Arm Type
Active Comparator
Arm Description
Patients who receive uterine artery embolization for symptomatic fibroids
Intervention Type
Procedure
Intervention Name(s)
catheter-directed sclerotherapy
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
surgical resection
Intervention Description
Surgical resection of the ovarian endometrioma is performed under general anesthesia. To preserve the residual ovarian function, enucleation is the primary surgical technique.
Primary Outcome Measure Information:
Title
Serum AMH
Description
Serum AMH: A measure of ovarian function
Time Frame
Serum AMH at 1month after catheter-directed sclerotherapy
Title
Serum AMH
Description
Serum AMH: A measure of ovarian function
Time Frame
Serum AMH at 6months after catheter-directed sclerotherapy
Title
Serum AMH
Description
Serum AMH: A measure of ovarian function
Time Frame
Serum AMH at 12 months after catheter-directed sclerotherapy
Secondary Outcome Measure Information:
Title
Recurrence
Description
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
Title
hospital stay
Description
Time from admission to discharge
Time Frame
duration of admission (days), up to 5 days
Title
serum CA-125
Description
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
Title
EHP-30 (Endometriosis Health Profile-30)
Description
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

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 1. Women with symptomatic fibroids (age: 20 - 60 years old) Exclusion Criteria: Gynecologic malignancy Ongoing infection or inflammation Coagulopathy (platelet < 50,000 or INR > 1.5) Extraovarian endometriosis Serum AMH of 5 or higher Drug allergy Illiteracy Pregnancy
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kichang Han
Phone
82-10-9722-6315
Email
wowsaycheese@yuhs.ac
Facility Information:
Facility Name
Yonsei University Health System, Severance Hospital
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kichang Han
Phone
82-10-9722-6315
Email
wowsaycheese@yuhs.ac

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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