Relation Between Ethanol Sclerotherapy for Endometrioma Systemic Immune Milieu

Endometriosis Clinical Trial

Official title:

Endometrioma Cystic Fluid Aspiration and Retained Ethanol Sclerotherapy Might Improve the Systemic Immune Milieu

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05470972
• Other study ID #: 35560/6/22
• Status: Completed
• Phase: Early Phase 1
• Start date: May 21, 2020
• Est. completion date: May 19, 2022

Study information

• Verified date: July 2022
• Source: Tanta University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 69
• Est. completion date: May 19, 2022
• Est. primary completion date: November 17, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 21 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Endometriosis

Intervention

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.

Locations

Country	Name	City	State
Egypt	Tanta university	Tanta	El-Gharbyia

Sponsors (1)

Lead Sponsor	Collaborator
Tanta University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The effect of AEST procedures on patients' cytokines levels.	The effect of AEST on patients serum levels of tumor necrosis factor-a, interleukin-8 and interleukin-10	6 months