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

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Yonsei University

Status

Unknown

Conditions

Ovarian Endometrioma

Treatments

Procedure: surgical resection
Procedure: catheter-directed sclerotherapy

Study type

Interventional

Funder types

Other

Identifiers

NCT05279209
4-2021-1512

Details and patient eligibility

About

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

Full 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

Enrollment

98 estimated patients

Sex

Female

Ages

19 to 60 years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

98 participants in 2 patient groups

Sclerotherapy
Experimental group
Description:
Patients who receive uterine artery embolization for symptomatic fibroids
Treatment:
Procedure: catheter-directed sclerotherapy
Surgery
Active Comparator group
Description:
Patients who receive uterine artery embolization for symptomatic fibroids
Treatment:
Procedure: surgical resection

Trial contacts and locations

1

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Central trial contact

Kichang Han

Data sourced from clinicaltrials.gov

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