Salpingectomy Versus Aspiration of Hydrosalpingeal Fluid Prior to IVF-ET.A Randomized Controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 160
- 试验地点
- 1
- 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 randomized controlled trial is to compare the efficacy of ultrasound guided aspiration of hydrosalpingeal fluid with salpingectomy in the management patients with ultrasound visible hydrosalpinges undergoing IVF-ET.
详细描述
The adverse impact of hydrosalpinx on in vitro fertilisation embryo transfer (IVF-ET) outcomes has been confirmed by several retrospective and prospective studies .
Cochrane review of prospective randomised 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 or previous multiple laparotomies. Furthermore, many infertile couples refuse to undergo bilateral salpingectomy or proximal tubal occlusion because these procedures remove any hope of spontaneous pregnancy. Other less invasive options for patients with hydrosalpinges as ultrasound-guided aspiration of hydrosalpingeal fluid, antibiotics (alone or combined with aspiration) 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 because most of the supporting evidences for these methods come from small retrospective studies.
A recent randomized controlled trial revealed that the aspiration of hydrosalpingeal fluid at the time of oocyte retrieval was associated with improved implantation rate and pregnancy rates.
The aim of this randomized controlled trial is to compare the efficacy of ultrasound guided aspiration of hydrosalpingeal fluid with salpingectomy in the management patients with ultrasound visible hydrosalpinges undergoing 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.
研究组 & 干预措施
Needle aspiration of hydrosalpinx
Aspiration of hydrosalpingeal fluid under ultrasound guidance
干预措施: Needle aspiration of hydrosalpinx (Procedure)
salpingectomy
Surgical removal of hydrosalpinx
干预措施: Salpingectomy (Procedure)
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
次要结局
- The Number of Participants Who Achieved Ongoing Pregnancy in a Transfer Cycle .(18 weeks after embryo transfer)
研究者
Prof .Usama M.Fouda
M.D , PhD
Aljazeera Hospital