Laparoscopic Sclerotherapy for Management of Endometriomas: A Pilot Study Evaluating Impact on Ovarian Reserve
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 20
- 主要终点
- AMH
研究概览
简要总结
The objective of this study is to evaluate the effect of laparoscopic sclerotherapy on ovarian reserve and its overall efficacy in the treatment of endometriomas. Ovarian reserve will be assessed using preoperative and postoperative anti-Müllerian hormone (AMH) levels and antral follicle count (AFC). Traditionally, ovarian endometriomas are managed by complete cystectomy; however, multiple studies including a large systematic review and meta-analysis-have demonstrated that cystectomy significantly reduces ovarian reserve, with an average decline in AMH of 1.77 ng/mL within one to six weeks postoperatively without recovery to baseline after many months. Sclerotherapy has historically been a potential alternative, typically performed by interventional radiology via transvaginal, transabdominal, or transgluteal drainage. This percutaneous approach, however, precludes direct visualization of the cyst and surgical management of concurrent conditions including endometriosis peritoneal disease, excision, adhesions, or tubal disease.
Several studies have explored the feasibility and effectiveness of laparoscopic sclerotherapy, reporting encouraging results regarding its safety, increased AFC compared with cystectomy, and comparable pregnancy rates. Nonetheless, none of these studies have been conducted in the United States, and few have utilized a laparoscopic approach. Further research is therefore warranted to establish the accessibility and reproducibility of this technique. The investigators aim to conduct the first U.S.-based study evaluating the impact of laparoscopic sclerotherapy on ovarian reserve. The primary outcome will be the change in AMH and AFC at six weeks postoperatively. Consistent with prior evidence, the investigators hypothesize that laparoscopic sclerotherapy will result in a smaller decline in ovarian reserve compared with traditional cystectomy.
详细描述
Primary Endpoint:
- The change in pre op and post op AMH levels and Antral Follicle Count in patients with ovarian endometriomas.
Secondary Endpoints:
- Evidence of cyst resolution at 6-week ultrasound
- Recurrence of new endometriomas
- If any further surgical interventions are performed at the same time as sclerotherapy such as excision of endometriosis, tubal evaluation, hysteroscopy, etc.
Exploratory endpoints:
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 55 Years(Adult)
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •English speaking
- •Age of 18 or greater
- •At least one ovarian endometrioma > 4 cm in size
- •Desires to proceed with surgical management of the endometrioma
排除标准
- •Known diminished ovarian reserve (AMH < 1.0)
- •Known allergies to ethanol solutions
- •Pregnancy
研究组 & 干预措施
Laparoscopic Sclerotherapy
Patients who choose to undergo laparoscopic sclerotherapy for management of their ovarian endometrioma.
干预措施: Laparoscopic sclerotherapy (Procedure)
结局指标
主要结局
AMH
时间窗: 6 weeks
Change in AMH from pre op appintment to 6 week post op appointment.
Antral Follicle Count
时间窗: 6 weeks
An Ultrasound will be performed at 6 weeks post op to assess antral follicle count
次要结局
- Endometrioma resolution(6 weeks)
- Endometrioma recurrence(6 weeks)
- Post operative complications(6 weeks)
研究者
Magdy Milad, MD
Albert B Gerbie Professor
Northwestern University
