Ovarian Endometrioma
Conditions
Keywords
Endometrioma, resection, enucleation, sclerotherapy, ovarian function
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
Interventions
PROCEDUREcatheter-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.
PROCEDUREsurgical resection
Surgical resection of the ovarian endometrioma is performed under general anesthesia. To preserve the residual ovarian function, enucleation is the primary surgical technique.
Sponsors
Yonsei University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
19 Years to 60 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Serum AMH | Serum AMH at 1month after catheter-directed sclerotherapy | Serum AMH: A measure of ovarian function |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Recurrence | 1, 6, and 12 months | 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 | duration of admission (days), up to 5 days | Time from admission to discharge |
| serum CA-125 | 1, 6, 12 months | 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) | 6 and 12 months | 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) |
Countries
South Korea
Contacts
Primary ContactKichang Han
Outcome results
None listed