The Impact of Ethanol Sclerotherapy Before ART (Assisted Reproductive Technology) Cycle on Cumulative Live Birth Rate in Infertile Women With Endometrioma: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 84
- 试验地点
- 4
- 主要终点
- Cumulative live birth rate
研究概览
简要总结
The goal of this randomized controlled trial is to assess the impact of ethanol sclerotherapy on ART cycle outcomes. The main questions it aims to answer are:
- Does ethanol sclerotherapy before ART cycle has any impact on cumulative live birth rate in patients with endometrioma?
- Does ethanol sclerotherapy improve chronic pelvic pain, dysmenorrhea, complications during oocyte retrieval, response to ovarian stimulation (number of mature oocytes retrieved), and pregnancy loss rates?
Infertile patients with endometrioma between 4-10 cm who are scheduled for ART within 2 cycles will be randomized to ethanol sclerotherapy or no intervention.
详细描述
The effect of ethanol sclerotherapy before assisted reproductive technology (ART) cycle in patients with endometrioma on reproductive outcomes will be investigated. While endometrioma may result in technical difficulties in the ART process, the superiority of ethanol sclerotherapy has yet to be examined before the ART procedure in randomized controlled studies and meta-analyses. The negative effect of ethanol sclerotherapy on ovarian reserve was found to be less than other existing interventions such as cyst stripping. However, randomized controlled studies did not determine its direct effect on ART outcome. Our current study aimed to assess the effect of ethanol sclerotherapy on ART outcomes.
Infertile patients aged 18-40 years with at least one endometrioma 4-10 cm and scheduled for ART will be included in the study. Patients with any untreated thyroid dysfunction or additional disease, such as hyperprolactinemia, those who did not accept the study information and consent, and patients younger than 18 or older than 40 will not be included. Those who underwent surgery for endometrioma within 3 months before ART will be excluded. In addition, patients with an anti-mullerian hormone value below 0.3 ng/ml will not be included in the 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
- 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
- 是
入选标准
- •AMH>0.3 ng/ml
- •unilateral/bilateral endometrioma
- •Endometrioma diameter 40-100 mm
排除标准
- •3 or more IVF/embryo transfer failure
- •Menstrual cycle abnormalities
- •Male Factor infertility
- •Presence of uterine fibroids
- •Presence of hydrosalpinx
- •Presence of uterine abnormalities
- •Suspicion of malignancy according to International Ovarian Tumor Analysis criteria
结局指标
主要结局
Cumulative live birth rate
时间窗: 18 months
live births following fresh and frozen-thaw transfer of all embryos unless pregnancy occurs
次要结局
- pain scores(3 months)
研究者
Yavuz Emre Şükür
associate professor
Ankara University