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临床试验/NCT06971458
NCT06971458招募中不适用

Endometrioma Ethanol Sclerotherapy and Its Effect on Ovarian Function and Fertility Treatment Outcome - Prospective Cohort Study Protocol

Hillel Yaffe Medical Center1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2022年8月9日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
120
试验地点
1
主要终点
The effect of

研究概览

简要总结

Ovarian endometriomas are cystic masses lined with endometrial tissue that contains fluid arising from a collection of menstrual debris. Ovarian endometriomas clinical manifestations includes pelvic pain, dysmenorrhea, dysfunctional uterine bleeding, and infertility.

Endometriomas are most commonly treated either medically or by surgical excision.

Ultrasonography (US)-guided aspiration and sclerotherapy is a new approach. Its mechanism of action is believed to be destruction of the inner epithelial lining, which is followed by inflammation and fibrosis, eventually resulting in regression of the cyst. The main advantage in this approach is the avoidance of collateral damage to the ovary.

详细描述

Endometriosis is a disease of the female reproductive system in which cells similar to those in the endometrium grow outside the uterus. Endometriosis prevalence is estimated to be around 10%, and even higher among women with infertility.

Endometriosis can involve any pelvic organ and in rare cases it may also occur in other parts of the body.

Ovarian endometriomas are cystic masses lined with endometrial tissue that contains fluid arising from a collection of menstrual debris. Ovarian endometriomas clinical manifestations includes pelvic pain, dysmenorrhea, dysfunctional uterine bleeding, and infertility.

Endometriomas are most commonly treated either medically or by surgical excision. Surgical excision is considered the standard therapy when pain is not controlled well by medication or when malignancy is being suspected. However, deterioration in the ovarian reserve after cystectomy is inevitable due to the removal of normal ovarian tissue adjacent to the endometrioma, and the possibility of excessive electrocoagulation for hemostasis.

Ultrasonography (US)-guided aspiration and sclerotherapy is a new approach. Its mechanism of action is believed to be destruction of the inner epithelial lining, which is followed by inflammation and fibrosis, eventually resulting in regression of the cyst. The main advantage in this approach is the avoidance of collateral damage to the ovary. There are still no guidelines suggesting US-guided sclerotherapy for endometrioma, although it has been used worldwide over the years since its introduction, and is reported to be an effective therapeutic option for endometriosis-associated pain and infertility. There are several reports of a higher oocyte number and higher pregnancy rate in IVF treatments after sclerotherapy in comparison with IVF after cystectomy. There is also a report of higher pregnancy rate in IVF treatments after sclerotherapy in comparison with leaving the endometrioma in-situ.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 41 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • A woman with endometrioma with a diameter of 25-100 mm

排除标准

  • Other causes of infertility (sperm disorder, ovulation disorder, uterine disorder, mechanical factor, poor ovarian reserve)

结局指标

主要结局

The effect of

时间窗: 3 Years

ultrasound (US)-guided sclerotherapy for the treatment of ovarian endometrioma effect on ovarian function and fertility treatment outcome.

次要结局

未报告次要终点

研究者

申办方类型
Other Gov
责任方
Sponsor

研究点 (1)

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