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Relation Between Ethanol Sclerotherapy for Endometrioma Systemic Immune Milieu

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

Status
Completed
Phases
Early Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05470972
Enrollment
69
Registered
2022-07-22
Start date
2020-05-21
Completion date
2022-05-19
Last updated
2022-07-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Endometriosis

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.

Interventions

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.

Sponsors

Tanta University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
21 Years to 45 Years
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

Design outcomes

Primary

MeasureTime frameDescription
The effect of AEST procedures on patients' cytokines levels.6 monthsThe effect of AEST on patients serum levels of tumor necrosis factor-α, interleukin-8 and interleukin-10

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026