Endometrioma Treatment and Ovarian Function
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
- 否
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
Jan Humplik, MD
Principal investigator
Charles University, Czech Republic
