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Completed

NCT Number: NCT05470972

Relation Between Ethanol Sclerotherapy for Endometrioma Systemic Immune Milieu

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.

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Key information

Conditions

Endometriosis Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Urogenital Diseases

Age range

21 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Early Phase 1

Primary location

Tanta university

Tanta, El-Gharbyia, 13511, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ethanol Injection

Drug

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 outcomes

  1. The effect of AEST procedures on patients' cytokines levels.

    Time frame: 6 months

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

Sponsors and collaborators

Lead sponsor

Tanta University

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2022
First posted
Jul 22, 2022
Registry last updated
Jul 22, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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