Catheter-directed Sclerotherapy Versus Surgical Resecction: Randomized Controlled Trial Comparing Ovarian Function and Therapeutic Efficacy After Treatment of Ovarian Endometrioma
1 other identifier
interventional
98
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Dec 2021
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 18, 2021
CompletedFirst Submitted
Initial submission to the registry
January 11, 2022
CompletedFirst Posted
Study publicly available on registry
March 15, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 17, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 17, 2023
CompletedMarch 15, 2022
March 1, 2022
12 months
January 11, 2022
March 14, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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
Secondary Outcomes (4)
Recurrence
1, 6, and 12 months
hospital stay
duration of admission (days), up to 5 days
serum CA-125
1, 6, 12 months
EHP-30 (Endometriosis Health Profile-30)
6 and 12 months
Study Arms (2)
Sclerotherapy
EXPERIMENTALPatients who receive uterine artery embolization for symptomatic fibroids
Surgery
ACTIVE COMPARATORPatients who receive uterine artery embolization for symptomatic fibroids
Interventions
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.
Eligibility Criteria
You may qualify if:
- \. Women with symptomatic fibroids (age: 20 - 60 years old)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Yonsei University Health System, Severance Hospital
Seoul, South Korea
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 11, 2022
First Posted
March 15, 2022
Study Start
December 18, 2021
Primary Completion
December 17, 2022
Study Completion
December 17, 2023
Last Updated
March 15, 2022
Record last verified: 2022-03
Data Sharing
- IPD Sharing
- Will not share