NCT04151433招募中不适用
BLAST: a Randomized Controlled Trial on Conservative Endometrioma Surgery Using the CO2 Laser: the Combined Technique Versus CO2 Laser Vaporization Only
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 92
- 试验地点
- 7
- 主要终点
- AMH levels 3 months postoperatively
研究概览
简要总结
To study which surgical technique offers better results in treating endometriomas in terms of ovarian reserve preservation.
The 2 conservatives techniques used are:
- The combined technique
- CO2 laser vaporization only
Ovarian reserve will be assessed by consecutive measurements of AMH serum levels before and after surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age: 18 - 40 years (both inclusive)
- •Unilateral endometriotic cysts with a mean diameter of >=2.5cm and ≤8 cm, measured in 3 dimensions.
- •Presence of a contralateral endometrioma of ≤ 2cm is allowed
- •Complaining of infertility and/or pain
- •Use of contraception (combined or Progesteron only) for at least 4 weeks before surgery
排除标准
- •Incomplete surgery for the pelvis
- •Contra-indication for the use of contraception (combined or Progesteron only)
- •Use of GnRH analogues preoperatively and in the first 3 months postoperatively
- •(History of) hysterectomy
- •Prior unilateral oophorectomy
- •Pituitary/hypothalamic disorders
- •Suspected malignancy
- •Contralateral endometrioma of >2 cm
- •AMH <0.7 preoperatively
- •Pregnancy
结局指标
主要结局
AMH levels 3 months postoperatively
时间窗: 3 months postoperatively
To assess the effect of conservative laparoscopic treatment of endometrioma(s) on ovarian reserve as reflected by AMH in patients planned for laparoscopic CO2 laser surgery. For the primary outcome evaluation of serum AMH will be done before (baseline) and after (at 3 months follow up) laparoscopic treatment of endometrioma(s).
次要结局
未报告次要终点
研究者
研究点 (7)
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