Relation Between Ethanol Sclerotherapy for Endometrioma Systemic Immune Milieu
Endometrioma Cystic Fluid Aspiration and Retained Ethanol Sclerotherapy Might Improve the Systemic Immune Milieu
1 other identifier
interventional
69
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for early_phase_1
Started May 2020
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 21, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 17, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
May 19, 2022
CompletedFirst Submitted
Initial submission to the registry
July 17, 2022
CompletedFirst Posted
Study publicly available on registry
July 22, 2022
CompletedJuly 22, 2022
July 1, 2022
1.5 years
July 17, 2022
July 20, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
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
6 months
Study Arms (1)
Ovarian Endometrioma
EXPERIMENTALOvarian endometrioma (OE) is in women of reproductive age
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.
Eligibility Criteria
You may qualify if:
- Women with OE of a mean diameter of \>3 cm
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Tanta Universitylead
Study Sites (1)
Tanta university
Tanta, El-Gharbyia, 13511, Egypt
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- early phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant professor of gynecology
Study Record Dates
First Submitted
July 17, 2022
First Posted
July 22, 2022
Study Start
May 21, 2020
Primary Completion
November 17, 2021
Study Completion
May 19, 2022
Last Updated
July 22, 2022
Record last verified: 2022-07