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Relation Between Ethanol Sclerotherapy for Endometrioma Systemic Immune Milieu

Sponsor
Tanta University (Other)
Overall Status
Completed
CT.gov ID
NCT05470972
Collaborator
(none)
69
Enrollment
1
Location
1
Arm
23.9
Actual Duration (Months)
2.9
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Ethanol Injection
 Early Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
69 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Endometrioma Cystic Fluid Aspiration and Retained Ethanol Sclerotherapy Might Improve the Systemic Immune Milieu
Actual Study Start Date :
May 21, 2020
Actual Primary Completion Date :
Nov 17, 2021
Actual Study Completion Date :
May 19, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Ovarian Endometrioma

Ovarian endometrioma (OE) is in women of reproductive age

Drug: Ethanol Injection
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.

Outcome Measures

Primary Outcome Measures

  1. The effect of AEST procedures on patients' cytokines levels. [6 months]

    The effect of AEST on patients serum levels of tumor necrosis factor-α, interleukin-8 and interleukin-10

Eligibility Criteria

Criteria

Ages Eligible for Study:
21 Years to 45 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Tanta university Tanta El-Gharbyia Egypt 13511

Sponsors and Collaborators

  • Tanta University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Ahmed Hagars, Assistant professor of gynecology, Tanta University
ClinicalTrials.gov Identifier:
NCT05470972
Other Study ID Numbers:
  • 35560/6/22
First Posted:
Jul 22, 2022
Last Update Posted:
Jul 22, 2022
Last Verified:
Jul 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Endometriosis
Ethanol

Study Results

No Results Posted as of Jul 22, 2022