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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
Tanta University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Endometriosis

Eligibility Criteria

21 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

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

First Posted
July 17, 2022
Last Updated
July 20, 2022
Sponsor
Tanta University
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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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