Monocentric, Controlled, Randomized Trial: Comparison of Pregnancy Rates in Women With One or More Endometriomas, Treated by Cystectomy, Plasma Vaporization, or Sclerotherapy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 332
- 试验地点
- 1
- 主要终点
- To compare pregnancy rates observed up to 24 months after surgery for endometriosis with endometrioma treatment
研究概览
简要总结
The goal of this clinical trial is to compare pregnancy rates after different surgical treatments for endometriomas in adult women who have one or more ovarian cysts (endometriomas) larger than 2 cm requiring surgery. The main questions it aims to answer are:
How many women become pregnant within 24 months after surgery ? What are the birth rates and different types of pregnancies (natural, with fertility treatments, and those continuing beyond 12 weeks)? How often do the endometriomas come back after surgery? What surgery-related complications occur? How do pain levels change after treatment?
Researchers will compare different surgical treatment groups to see if one approach results in better pregnancy outcomes and fewer complications.
Participants will:
Be randomly assigned to different surgical treatment groups Undergo surgery for their endometriomas and endometriosis Attend follow-up visits at 3 months and 24 months after the procedure Have their pregnancy outcomes, pain levels, and potential complications monitored throughout the study period
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 43 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patient aged between 18 and 43 years (inclusive)
- •Patient diagnosed with endometriosis (by histology or imaging) and symptomatic, requiring surgery (pelvic pain and/or infertility and/or risk to an organ)
- •Pelvic MRI or ultrasound performed within the last year showing at least one endometrioma larger than 20 mm in diameter
- •Patient with an intention to conceive (probable or certain) after surgery
- •Patient informed and having signed the consent form
- •Patient covered by a social security scheme
排除标准
- •Intraoperative finding that the cyst is not an endometrioma
- •Patient under guardianship, conservatorship, or incapable of giving consent
- •Patient without sufficient understanding of the French language
- •Patient under judicial protection measures
- •Patient who is pregnant or breastfeeding
研究组 & 干预措施
cystectomy
Surgical removal of the endometrioma by gently pulling the cyst wall away from the ovarian tissue (divergent traction technique)
干预措施: Cystectomy (Procedure)
vaporization with plasma
It consists of destroying the cyst wall (vaporization) using plasma energy.
干预措施: plasma vaporization (Procedure)
sclerotherapy
Ethanol sclerotherapy destroys the endometriotic tissue lining the inner wall of the cyst through prolonged contact with 96% ethanol.
干预措施: Sclerotherapy (Procedure)
结局指标
主要结局
To compare pregnancy rates observed up to 24 months after surgery for endometriosis with endometrioma treatment
时间窗: From enrollment to 24 months after the surgery
A Pregnancy is considered if the CGH is \>1000 UI/L or a intra uterine pregnancy after 5 weeks of amenorrhea
次要结局
- To compare birth rates pregnancies(From enrollment to 24 months after the surgery)
- To compare spontaneous pregnancy rates(From enrollment to 24 months after the surgery)
- To compare pregnancies achieved through assisted reproductive technology (ART)(From enrollment to 24 months after the surgery)
- To compare pregnancies progressing beyond 12 weeks of amenorrhea(From enrollment to 24 months after the surgery)
- To compare the recurrence rate of endometriomas, defined as the appearance of an endometrioma larger than 2 cm on the same ovary.(From enrollment to 24 months after the surgery)
- To compare postoperative complication rates(During 3 months after the surgery)
- To compare pain scores using the Biberoglu and Behrman scale (Biberoglu and Behrman >4)(From enrollment to 24 months after the surgery)