Effect of Ultrasound Guided Aspiration of Hydrosalpingeal Fluid at the Time of Oocyte Retrieval on the Outcomes of IVF-ET, a Randomized Controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 110
- 试验地点
- 2
- 主要终点
- The Number of Participants Who Achieved Clinical Pregnancy in a Transfer Cycle
研究概览
简要总结
The aim of this study is to determine whether the ultrasound guided aspiration of hydrosalpingeal fluid at the time of oocyte retrieval can improve the outcomes of IVF-ET .
详细描述
A Cochrane review of prospective randomized trials of laparoscopic salpingectomy confirmed the beneficial effect of laparoscopic salpingectomy on IVF ET outcomes in patients with hydrosalpinges. Surgery is not usually safe especially in patients with extensive adhesions, morbid obesity and previous multiple laparotomies. Other less invasive options for patients with hydrosalpinges as ultrasound guided aspiration of hydrosalpingeal fluid, antibiotics and hysteroscopic occlusion of fallopian tube were studied in order to find an alternative to salpingectomy. Although these methods are simple and getting popular,current data are inadequate to recommend these treatment options instead of salpingectomy. The aim of this study is to determine whether the ultrasound guided aspiration of hydrosalpingeal fluid at the time of oocyte retrieval can improve the outcomes of IVF-ET .
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 37 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients with unilateral or bilateral hydrosalpinges visible by ultrasound
- •Age between 18 - 37 years
- •Period of infertility > 1 year
- •Body mass index between 19-29
- •Normal basal luteinizing hormone (LH), follicle stimulating hormone (FSH) and prolactin concentrations
- •Normal recent semen analysis (according to World Health Organization criteria)
排除标准
- •Uterine fibroid requiring surgical removal
- •Endometriosis
- •Male factor of infertility requiring ICSI
- •Previous IVF cycles
- •History of recurrent miscarriage
- •Endocrinologic disorders
- •Presence of systemic disease contraindicating pregnancy
结局指标
主要结局
The Number of Participants Who Achieved Clinical Pregnancy in a Transfer Cycle
时间窗: 5 weeks after embryo transfer
The Number of Participants Who Achieved Clinical Pregnancy( presence of intrauterine gestational sac detected by transvaginal ultrasound )in a transfer cycle
次要结局
- The Number of Participants Who Achieved Ongoing Pregnancy in a Transfer Cycle .(18 weeks after embryo transfer)