Impact on Ovarian Reserve According to the Type of Ovarian Endometrioma Excision: Laser Versus Conventional Cystectomy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 16
- 主要终点
- Ovarian volume
研究概览
简要总结
Endometriosis is a disease characterized by the presence of endometrial tissue outside the uterus cavity, causing important chronic pain and sterility in those patients suffering from it. It affects from 10 to 20% of women at reproductive age. Different types of endometriosis, which can coexist in the same patient, exist: deep infiltrating endometriosis (implants infiltrate > 5 mm the peritoneum), superficial endometriosis and ovarian endometriosis (OMA). OMA sometimes require surgery, and it is known that healthy ovarian tissue is also injured during resection. Consequently, ovarian reserve decreases, worsening the reproductive prognosis of patients affected. The main objective of the present study is to compare laser versus conventional OMA excision according to ovarian reserve in a pairwise-data study.
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
- Triple (Participant, Care Provider, Investigator)
盲法说明
The ultrasonographer will be blinded to the procedure performed in each ovary after surgery. The patient will not be told which procedure has been performed in each ovary. The investigator will not know which procedure has been performed in each ovary until the end of the study. Only the surgeon will know which procedure is performed in each ovary.
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age between 18 and
- •Bilateral endometriomas.
- •Endometrioma size > 3 cm.
- •Pain and/or infertility as indication to surgical treatment.
排除标准
- •History of cancer.
- •Suspected malignancy.
- •Evidence of premature ovarian failure.
研究组 & 干预措施
Stripping technique
The endometrioma is removed according to standard surgery.
干预措施: Stripping technique (Procedure)
Laser technique
The endometrioma is drained, everted and then the inner wall of the endometrioma is vaporised with CO2 laser
干预措施: CO2 (carbon dioxide) laser vaporisation (Procedure)
结局指标
主要结局
Ovarian volume
时间窗: 7 months
Ovarian volume will be assesses by ultrasound, units given with milliliters
Ovarian reserve
时间窗: 7 months
Antral follicular count by ultrasound: number of antral follicles.
次要结局
- Pregnancy rate(6 months after surgery)
研究者
Francisco Carmona
Head of Gynecology
Hospital Clinic of Barcelona