Relation Between Ethanol Sclerotherapy for Endometrioma Systemic Immune Milieu
Primary Purpose
Endometriosis
Status
Completed
Phase
Early Phase 1
Locations
Egypt
Study Type
Interventional
Intervention
Ethanol Injection
Sponsored by
About this trial
This is an interventional treatment trial for Endometriosis
Eligibility Criteria
Inclusion Criteria:
- Women with OE of a mean diameter of >3 cm
Exclusion Criteria:
- Women with recurrent OE
- a cyst that was suspicious of being malignant
- diabetes mellitus
- polycystic ovary syndrome
- body mass index (BMI) of >30 kg/m2
- previous surgical interference that resulted in pelvic adhesions
Sites / Locations
- Tanta university
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Ovarian Endometrioma
Arm Description
Ovarian endometrioma (OE) is in women of reproductive age
Outcomes
Primary Outcome Measures
The effect of AEST procedures on patients' cytokines levels.
The effect of AEST on patients serum levels of tumor necrosis factor-α, interleukin-8 and interleukin-10
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05470972
Brief Title
Relation Between Ethanol Sclerotherapy for Endometrioma Systemic Immune Milieu
Official Title
Endometrioma Cystic Fluid Aspiration and Retained Ethanol Sclerotherapy Might Improve the Systemic Immune Milieu
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
May 21, 2020 (Actual)
Primary Completion Date
November 17, 2021 (Actual)
Study Completion Date
May 19, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tanta University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Design: Prospective interventional study. 69 women with OE were evaluated clinically and by transvaginal ultrasonography (TUV). AEST procedure was performed and the collected aspirate and pre-procedural blood samples were collected for estimation of cytokines' levels. At 6-m post-procedure, clinical evaluation and TUV were repeated and serum cytokines' levels were re-estimated.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endometriosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
69 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ovarian Endometrioma
Arm Type
Experimental
Arm Description
Ovarian endometrioma (OE) is in women of reproductive age
Intervention Type
Drug
Intervention Name(s)
Ethanol Injection
Intervention Description
The AEST procedure was performed as follows: vaginal walls were cleansed using vaginal povidone-iodine, a 17 gauge, 30-cm length needle was inserted through the posterior vaginal fornix into the pouch of Douglas, and the cyst was aspirated till complete disappearance of the cyst on the ultrasound scanner. The collected cystic fluid was collected into a plastic tube without an anticoagulant. The needle was maintained in its place, the syringe was removed and the cyst was flushed with saline solution until obtaining a clear liquid. Then, 96% ethanol was injected as 60% of the volume of the aspirated fluid to guard against over distension or rupture of the cyst and/or ethanol diffusion into the pelvis. The collected fluid was divided into three sterile tubes for cytological and bacteriological examinations and the study investigations. Patients were allowed to be completely recovered and were discharged home.
Primary Outcome Measure Information:
Title
The effect of AEST procedures on patients' cytokines levels.
Description
The effect of AEST on patients serum levels of tumor necrosis factor-α, interleukin-8 and interleukin-10
Time Frame
6 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Women with OE of a mean diameter of >3 cm
Exclusion Criteria:
Women with recurrent OE
a cyst that was suspicious of being malignant
diabetes mellitus
polycystic ovary syndrome
body mass index (BMI) of >30 kg/m2
previous surgical interference that resulted in pelvic adhesions
Facility Information:
Facility Name
Tanta university
City
Tanta
State/Province
El-Gharbyia
ZIP/Postal Code
13511
Country
Egypt
12. IPD Sharing Statement
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Relation Between Ethanol Sclerotherapy for Endometrioma Systemic Immune Milieu
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