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临床试验/NCT04452123
NCT04452123Unknown不适用

Endometrioma Treatment and Ovarian Function

Charles University, Czech Republic2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2020年7月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
100
试验地点
2
主要终点
Antral follicle count (AFC)

研究概览

简要总结

Ovarian endometriosis (endometrioma) can be a cause of subfertility. According to European Society of Human Reproduction and Embryology (ESHRE) guidelines, surgery for endometrioma is recommended when an endometrioma is more than 3 cm in diameter because this management is associated with better spontaneous conception rates. Nevertheless, surgery can also be potentially associated with a risk of destruction of functional ovarian tissue and reduction in ovarian reserve.

Anti-müllerian hormone (AMH) is a member of the Transforming Growth Factor beta family and is expressed by the small (<8 mm) pre-antral and early antral follicles. The AMH level reflects the size of the primordial follicle pool, and may be the best biochemical marker of ovarian function across an array of clinical situations Its level in serum is almost stable between 20 and 35 years of the woman´s life, unless using hormonal contraception and / or they suffer with Polycystic ovarian syndrome (PCOS). The level of AMH is also a useful indicator for the prediction chances of success of spontaneous or assisted conceptions. However, there paucity of data regarding changes in serum levels of AMH following surgery for endometrioma.

An alternative way for estimating ovarian reserve is quantifying ovarian mass with using standard 3D transvaginal ultrasound calculation (OVM) and assessment of antral follicular count.

The gold standard of endometrioma surgery is laparoscopic excision with suture or gentle coagulation of the rest of ovary or by the use of laparoscopic treatment with argon plasma energy.

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
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
20 Years 至 35 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • women with endometrioma 3cm and more in diameter

排除标准

  • using hormonal contraception or other hormonal treatment last 6 months
  • suffer with polycystic ovarian syndrome

结局指标

主要结局

Antral follicle count (AFC)

时间窗: 3 months, 1 year

Ultrasound count of Antral follicles after the surgery, counted 3-5. day of menstrual cycle

AMH

时间窗: 3 days,3-5 week postop., 3 months postop., 1 year (optional)

Changing of anti-müllerian hormon assay postop. in µg/L

Both ovarian volume

时间窗: 3 months, 1 year

Ultrasound volume of both ovaries in cm\^3, measured 3-5. day of menstrual cycle

次要结局

未报告次要终点

研究者

发起方
Charles University, Czech Republic
申办方类型
Other
责任方
Principal Investigator
主要研究者

Jan Humplik, MD

Principal investigator

Charles University, Czech Republic

研究点 (2)

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