The Impact of Surgical Treatment of Ovarian Endometriomas on Ovarian Reserve: a Randomised Controlled Trial of Laparoscopic Ovarian Cystectomy Versus Cyst Ablation - a Pilot Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Anti-Mullerian Hormone (AMH)
研究概览
简要总结
The aim of this study is to assess which of two commonly used surgical procedures in the treatment of ovarian cysts called endometriomas (cutting out of the cyst - "cystectomy", or draining it and cauterising it's inner lining - "ablation") causes the least damage to the ovary and is therefore best at maintaining the future fertility potential of a patient.
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
- None
入排标准
- 年龄范围
- 18 Years 至 42 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women undergoing laparoscopic surgery for treatment of unilateral endometriomas measuring ≥ 3cm and ≤ 8cm in diameter
排除标准
- •Patients who have received oestrogen suppressing drugs (e.g. oral contraceptive pills, GnRHa) during the previous six months
- •Patients who have previously undergone surgical treatment of endometriomas
- •Patients with bilateral endometriomas
- •Patients with endometriomas of less than 3cm in size or more than 8cm in size
- •Pre-surgical evidence of reduced ovarian reserve
- •Pregnant patients
- •Patients unable to give informed consent e.g. patients with mental incapacity
研究组 & 干预措施
Cystectomy
Patients undergoing cystectomy for ovarian endometrioma
干预措施: Surgery for ovarian endometrioma (Procedure)
Ablation
Patients undergoing ablation for ovarian endometrioma
干预措施: Surgery for ovarian endometrioma (Procedure)
结局指标
主要结局
Anti-Mullerian Hormone (AMH)
时间窗: 6 months post-operatively
Change in anti-mullerian hormone level after surgery (at one week, three months and six months)
次要结局
- Follicle Stimulating Hormone (FSH)(6 months)
- Antral Follicle Count (AFC)(3 months)
研究者
Saad Amer
Associate Professor in Gynaecology
University Hospitals of Derby and Burton NHS Foundation Trust