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临床试验/NCT05470972
NCT05470972已完成早期 1 期

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

Tanta University1 个研究点 分布在 1 个国家目标入组 69 人开始时间: 2020年5月21日最近更新:
适应症
干预措施

试验速览

阶段
早期 1 期
状态
已完成
入组人数
69
试验地点
1
主要终点
The effect of AEST procedures on patients' cytokines levels.

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
21 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

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

排除标准

  • 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

研究组 & 干预措施

Ovarian Endometrioma

Experimental

Ovarian endometrioma (OE) is in women of reproductive age

干预措施: Ethanol Injection (Drug)

结局指标

主要结局

The effect of AEST procedures on patients' cytokines levels.

时间窗: 6 months

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

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ahmed Hagars

Assistant professor of gynecology

Tanta University

研究点 (1)

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