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临床试验/NCT06955221
NCT06955221招募中不适用

Effect of US-guided Alcohol Sclerotherapy for Endometriomas on Pelvic Pain and Quality of Life

Hospital Universitari de Bellvitge49 个研究点 分布在 1 个国家目标入组 288 人开始时间: 2025年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
288
试验地点
49
主要终点
Quality of Life of patients with endometrioma

研究概览

简要总结

The goal of this clinical trial is to evaluate whether ultrasound-guided alcohol sclerotherapy can improve pelvic pain and quality of life in women aged 18 to 45 diagnosed with ovarian endometriomas, compared to expectant management.

The main questions it aims to answer are:

  1. - Does sclerotherapy significantly reduce pelvic pain compared to expectant management?
  2. - Does sclerotherapy improve quality of life as measured by the EHP-5 score?

Researchers will compare the sclerotherapy group to the expectant management group to determine whether the intervention leads to greater improvement in pain and quality of life.

Participants will:

  • Be randomly assigned to one of two groups: (1) Sclerotherapy group: undergo ultrasound-guided puncture and alcohol sclerotherapy; (2) Control group: expectant management
  • Complete quality of life and pain assessments at baseline and after 6 months
  • Provide blood and urine samples for biomarker analysis (e.g., cortisol, IL-6, hsCRP, catecholamines)
  • Undergo ovarian reserve assessments (AMH, antral follicle count)
  • Be followed for adverse events, recurrence, fertility outcomes, and treatment-related costs

The study will follow an intention-to-treat and per-protocol analysis approach.

详细描述

Endometriosis is a chronic gynecological disease that affects women of reproductive age, characterized by the abnormal growth of endometrial tissue outside the uterine cavity.

It affects 5-10% of women of reproductive age (Becker et al., 2022) and is associated with infertility in 40% of cases (Coccia et al., 2008). Among its clinical forms, ovarian endometrioma is the most frequent, appearing in 15-45% of patients with endometriosis (Cranney et al., 2017). In addition to its impact on fertility, the main clinical manifestation of endometriosis is pain. Chronic pelvic pain caused by endometriosis can be disabling and even lead to work absenteeism, with a significant impact on the quality of life of affected patients, who often experience delayed diagnosis, making its management even more difficult and requiring a multidisciplinary approach (Horne & Missmer, 2022).

Currently, there is still no consensus on what should be the first-line treatment for ovarian endometrioma (Gordts & Campo, 2019). However, cystectomy reduces ovarian reserve due to the removal of healthy ovarian tissue adjacent to the cyst wall-something that further worsens the reproductive prognosis in patients whose fertility is already diminished due to endometriosis per se (Alborzi et al., 2021; Martinez-Garcia et al., 2021). Moreover, despite surgical removal of the endometrioma, the recurrence rate is high, ranging from 15-30% (Jee, 2022).

In recent years, there has been a shift toward more conservative treatments for the management of endometrioma, such as expectant management or aspiration and sclerosis (Garcia-Tejedor et al., 2020). Various authors have shown that ultrasound-guided aspiration and alcohol sclerosis may be a promising option, as concluded in the meta-analysis by Cohen et al., which found that recurrence rates were similar to those of laparoscopic management of ovarian endometrioma, but with fewer complications. Results in assisted reproductive technology are also better compared to surgical treatment in symptomatic women, particularly in those with low ovarian reserve (Zhang et al., 2022). Furthermore, other comparative studies between surgery and aspiration-sclerosis have shown that, although recurrence rates are similar, pregnancy rates are higher in patients treated with sclerosis, with the same complication rate and significantly lower costs (Garcia-Tejedor et al., 2020; Zhang et al., 2022).

Currently, the first-line treatment in patients diagnosed with endometriosis is hormonal therapy through the use of hormonal contraceptives. However, its efficacy in managing endometrioma is lower, and therefore, there is no consensus on its indication for this specific form of endometriosis (Cranney et al., 2017). In patients with a desire for pregnancy, alternative approaches are sought that do not interfere with fertility. At present, this often involves proceeding with in vitro fertilization without treating the endometrioma first, followed by surgery if needed (Miquel et al., 2020).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

盲法说明

Masking Description

入排标准

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

入选标准

  • Female sex
  • Age ≥18 and ≤45 years
  • Ultrasound suspicion of unilocular endometrioma or with a thin septum less than 3 mm
  • Size between 30-100 mm, persistent for at least 3-6 months since diagnosis
  • Ca125 marker <300 UI/mL and HE4 < 70 pM
  • Signed informed consent

排除标准

  • Age <18 or >45 years
  • History of ovarian or uterine cancer
  • Endometrioma size <30 mm or >100 mm
  • Indication for surgical treatment of the endometrioma due to suspected severe extra-ovarian endometriosis or any other cause
  • Ultrasound suspicion of dermoid cysts, anechoic cysts, or cysts with high risk of malignancy
  • Ca125 >300 UI/mL
  • HE4 >70 pM
  • Pregnant women
  • Patients who do not wish to participate in the study or who are mentally incapacitated

研究组 & 干预措施

Ultrasound-guided aspiration and alcohol sclerotherapy

Experimental

US-guided alcohol sclerotherapy of endometriomas with absolute etanol during 15 minutes, followed by a posterior wash.

干预措施: Ultrasound-guided aspiration and alcohol sclerotherapy (Procedure)

Control group

No Intervention

Expectant management with standard pain management if required

结局指标

主要结局

Quality of Life of patients with endometrioma

时间窗: Baseline and at 6 months

Endometriosis Health Profile-5 (EHP-5), the minimum and maximum values (1-5), higher scores mean a worse outcome.

次要结局

  • Changes in pain-associated biomarkers 1(Baseline and at 6 months)
  • Changes in pain-associated biomarkers 2(Baseline and at 6 months)
  • Changes in pain-associated biomarkers 3(Baseline and at 6 months)
  • Changes in pain-associated biomarkers 4(Baseline and at 6 months)
  • Changes in pain-associated biomarkers 5(Baseline and at 6 months)
  • Changes in pain-associated biomarkers 6(Baseline and at 6 months)
  • Pregnancy(Through study completion, an average of 2 years)
  • Reduction in cyst size(Baseline and at 6 months)
  • Adverse events and complications(Baseline and at 6 months)
  • Misdiagnosed cysts(During procedure)
  • Healthcare costs(Baseline to 6 months)
  • Pelvic pain(Baseline and at 6 months)
  • Fertility preservation(Baseline and at 6 months)
  • Antral follicle(Baseline and at 6 months)
  • Pregnacy(through study completion, an average of 2 year)

研究者

发起方
Hospital Universitari de Bellvitge
申办方类型
Other
责任方
Principal Investigator
主要研究者

Amparo Garcia-Tejedor

Clinical Professor, Principal Investigator

Hospital Universitari de Bellvitge

研究点 (49)

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