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临床试验/NCT03484546
NCT03484546已完成不适用

Optimum Menstrual Cycle Time for Endometrioma Excision

Acibadem University3 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2018年3月26日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
60
试验地点
3
主要终点
Determination of ovarian follicle damage via histological examination

研究概览

简要总结

This study evaluates the optimum day of menstrual period for the excision of endometriomas to minimize the damage of surgery to normal ovarian tissue. Patients will be grouped as follicular, ovulatory and luteal according to menstrual days. Ovarian damage will be evaluated with both pathologic examination and anti-mullerian hormone levels before and after the surgery.

详细描述

Endometriosis is a common gynecologic disease seen in about 10% of women in reproductive age. The most common site of endometriosis is overt. Cystic formation of ovarian endometriosis is called endometrioma (chocolate cyst). Definitive treatment of endometriomas is excision by laparoscopy. The disadvantage of this surgery is the removal of some of the normal ovarian follicles within cystectomy material. This procedure can damage the ovarian reserves with the treatment of endometriomas, which are already the cause of infertility, and lead to the conditions such as infertility or early menopause. It has been understood that the ovarian reserves of the patients who underwent endometrioma cystectomy with the decrease of the Anti-Mullerian Hormone values, which is an over reserve parameter.

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 40 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • 4 to 10 cm unilateral ovarian endometrioma
  • having clinically indication of laparoscopic ovarian endometrioma excision

排除标准

  • prior gynecologic surgery
  • prior abdominal surgery
  • additional operation in the same session
  • having the diagnosis of premature ovarian failure or ovarian insufficiency
  • having any diagnosis of malignancy
  • having diagnosis of a non-gynecologic chronicle disease

结局指标

主要结局

Determination of ovarian follicle damage via histological examination

时间窗: 5 days after the surgery

Histologic evaluation of the cystectomy excision material for health ovarian follicles

Change of anti-mullerian hormone level 6 months after surgery

时间窗: 6 months

Comparison of pre-operative and 6 months after surgery of anti-mullerian hormone levels

次要结局

未报告次要终点

研究者

发起方
Acibadem University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Turgut Aydın

Assistant Professor

Acibadem University

研究点 (3)

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