Relation Between Ethanol Sclerotherapy for Endometrioma Systemic Immune Milieu

Early Phase 1

Completed

• Conditions: Endometriosis
• Interventions: Drug: Ethanol Injection

• Registration Number: NCT05470972
• Lead Sponsor: Tanta University

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2020-05-21
• Primary Completion: 2021-11-17
• Study Completion: 2022-05-19
• Status Verified: 2022-07
• Study First Submitted: 2022-07-17
• Study First Submitted QC: 2022-07-20
• Last Update Submitted: 2022-07-20
• Study First Posted: 2022-07-22
• Last Update Posted: 2022-07-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 69

Inclusion Criteria

• Women with OE of a mean diameter of >3 cm

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Ovarian Endometrioma	Ethanol Injection	Ovarian endometrioma (OE) is in women of reproductive age

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Tanta university; 🇪🇬 Tanta, El-Gharbyia, Egypt