NCT06878053尚未招募不适用
Benefit of Ethanol Sclerotherapy of Endometriomas Before Ovarian Stimulation on Pregnancy Rates in IVF/ICSI
Poissy-Saint Germain Hospital0 个研究点目标入组 174 人开始时间: 2025年6月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 174
- 主要终点
- cumulative rate of active pregnancies
研究概览
简要总结
Evaluation of progressive pregnancy rates (with an embryo with cardiac activity at 12 weeks), on a first attempt at IVF/ICSI (fresh and frozen embryo transfers) following the discovery of one or two endometrioma(s) of 30 to 80 mm, without a history of cystectomy, and comparison between the two groups: ethanol sclerotherapy and therapeutic abstention
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
- •Infertile women aged 18 to 43,
- •Presenting one or 2 endometriotic cysts of 30 mm to 80 mm long axis, confirmed by ultrasound and/or pelvic MRI and without signs of atypia,
- •With indication of IVF/ICSI, first IVF/ICSI after the discovery of endometriosis cyst(s),
- •Having given their consent.
排除标准
- •A history of ovarian cystectomy,
- •A non-homogeneous cyst that cannot be punctured (risk of incomplete aspiration),
- •Complex adnexal image that cannot exclude an associated hematosalpinx (communicating hematosalpinx, tissue component),
- •A recent tubo-ovarian infection,
- •An active, untreated vaginal infection,
- •Anticoagulant treatment at a therapeutic dose,
- •All adult patients protected by law (under guardianship or curatorship),
- •Problems understanding the French language,
- •Participation in intervention research,
- •All patients not affiliated to the social security system.
研究组 & 干预措施
ethanol sclerotherapy group
Experimental
干预措施: ethanol sclerotherapy (Procedure)
group without intervention
No Intervention
结局指标
主要结局
cumulative rate of active pregnancies
时间窗: 12 weeks
Cumulative rate of active pregnancies defined by the presence of an embryo with cardiac activity at 12 weeks per IVF/ICSI cycle, including fresh and frozen embryo transfers in an IVF/ICSI attempt.
次要结局
未报告次要终点
研究者
Nelly SWIERKOWSKI-BLANCHARD, MD
MD
Poissy-Saint Germain Hospital
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