Calcium Dobesilate Versus Coasting for Prevention of Ovarian Hyperstimulation Syndrome
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Number of participants with ovarian hyperstimulation syndrome (OHSS)
研究概览
简要总结
The purpose of this study is to compare the effect of oral Calcium Dobesilate versus costing in the prevention of ovarian hyperstimulation syndrome (OHSS) in high-risk women underwent intracytoplasmic sperm injection (ICSI).
详细描述
Two hundred and twenty women at risk of ovarian hyperstimulation syndrome during ICSI cycles will be randomly scheduled into two equal groups. In group A, (Calcium Dobesilate group), 1 cap / 8 hs Doxium ( 500mg) will be given at day of HCG injection and for 3 weeks ; while in group B (Coasting group), coasting (withholding gonadotrophins while maintaining pituitary suppression) follow up every day by measuring E2 for 3 days then either giving triggering or cycle cancellation is done
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 23 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Infertile women undergoing intracytoplasmic sperm injection or polycystic ovarian syndrome (PCO) with one of the following:
- •Presence of more than 20 follicles by ultrasound
- •E2 more than 3000 pg/ml
- •Retrieval of more than 15 follicles
排除标准
- 未提供
研究组 & 干预措施
group A
In group A, (Calcium Dobesilate group), 1 cap / 8 hs Calcium Dobesilate ( 500mg) will be given from at day of HCG injection and for 21 days.
干预措施: Calcium Dobesilate (Drug)
group B
In group B, coasting (withholding gonadotrophins while maintaining pituitary suppression) for 3 days then either giving triggering or cycle cancellation is done
干预措施: coasting (Other)
结局指标
主要结局
Number of participants with ovarian hyperstimulation syndrome (OHSS)
时间窗: every two weeks for eight weeks
this will be assessed by: Clinically: Abdominal bloating Mild abdominal pain Nausea ± vomiting Oliguria Acute respiratory distress syndrome By ultrasound Ovarian size usually ˃8 cm Ultrasound evidence of ascites Laboratory Haemoconcentration haematocrit ˃45% Hypoproteinaemia
次要结局
- pregnancy rate(14 days after embryos transfer)
研究者
khalid abd aziz mohamed
lecturer of ob/gyn
Benha University