Comparative Controlled Trial of Treatment of Minor Unexpected Uterine Cavity Abnormalities Diagnosed by Office Hysteroscopy Screening in Women Indicated for IVF
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- UMC Utrecht
- 入组人数
- 700
- 试验地点
- 1
- 主要终点
- Cumulative implantation rate
研究概览
简要总结
This is a comparative, controlled trial to evaluate the impact of treating undetected, asymptomatic, predefined minor uterine cavity abnormalities on the success of IVF treatment.
详细描述
Introduction- Implantation failure after IVF may be due to endometrial function, embryo quality or a combination of both. The prevalence of minor intracavitary pathology in cases with an apparent normal transvaginal sonography (TVS) observed at hysteroscopy has been recorded to be 25-40%. Treatment of such pathology prior to initiating IVF/ICSI has been advocated without high-quality evidence.
Objective- To evaluate the impact of treating undetected, asymptomatic, predefined minor uterine cavity abnormalities on the success of IVF treatment.
Material & methods- Patients, indicated for their first IVF/ICSI treatment cycle at the UMC Utrecht and AZ-VUB Brussels, initially underwent TVS. In case of a normal TVS these patients were scheduled for hysteroscopy in the early-mid follicular phase of the cycle, one to three months before starting IVF/ICSI treatment. Vaginoscopic hysteroscopy was performed in an ambulatory office setting. During the hysteroscopy a biopsy was taken, to diagnose chronic endometrial inflammation. In case of finding a predefined intra uterine abnormality (polyp, myoma, adhesion, septum, endometrial inflammation) randomisation took place if prior to hysteroscopy informed consent had been obtained for endoscopy treatment versus no treatment. Shortly after the hysteroscopy, IVF/ICSI treatment was initiated and outcome during one year treatment period will be recorded.
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
- — 至 36 Years(Child, Adult)
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Normal Transvaginal Ultrasound
- •No prior hysteroscopy
- •Regular menstrual cycle
- •Single embryo transfer
- •BMI between 18 and 29
- •Presence of both ovaries
- •Primary or secondary infertility
- •Women indicated for a first IVF/ICSI cycle
排除标准
- •Recurrent miscarriage
- •Prior hysteroscopic treatments
- •Endometriosis > AFS Stage II
- •Meno-metrorrhagia (defined as any intermenstrual loss of blood)
- •Submucosal/Intracavitary Fibroids taking more than 50% of the cavity
- •Hydrosalpinx
- •FSH/LH > 12IU/L on day 3
- •Polyps taking more than 50% of the cavity
- •Severe adhesions > grade II
研究组 & 干预措施
2
One or more of the predefined minor intra-uterine abnormalities have been detected and treated during hysteroscopy.
干预措施: Treatment of predefined abnormality by hysteroscopic surgery (Procedure)
2
One or more of the predefined minor intra-uterine abnormalities have been detected and treated during hysteroscopy.
干预措施: Ofloxacinum/Doxycycline (Drug)
结局指标
主要结局
Cumulative implantation rate
时间窗: One year
次要结局
- Presence of minor uterine abnormalities(At hysteroscopy)
- Cumulative ongoing pregnancy(One year)
