Diosmin Versus Cabergoline for Prevention of Ovarian Hyperstimulation Syndrome
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 2
- 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 Diosmin to oral Cabergoline in the prevention of ovarian hyperstimulation syndrome (OHSS) in high-risk women underwent intracytoplasmic sperm injection (ICSI).
详细描述
Two hundred women at risk of ovarian hyperstimulation syndrome during ICSI cycles will be randomly scheduled into two equal groups. In group A, (Diosmin group), 2 tab / 8 hs Diosmin ( 500mg) will be given at day of HCG injection and for 2 weeks ; while in group B (Cabergoline group), 1 tab/day Cabergoline( 0.5 mg) will be given at day of HCG injection and for eight days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 23 Years 至 48 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 ovarin 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 (Diosmin group)
In group A, (Diosmin group), 2 tab / 8 hs Diosmin ( 500mg) will be given from at day of HCG injection and for 14 days.
干预措施: Diosmin (Drug)
Group B(Cabergoline group)
while in group B (Cabergoline group), 1 tab/day Cabergoline(Dostinex)( 0.5 mg) will be given at day of HCG injection and for 8 days .
干预措施: Cabergoline (Drug)
结局指标
主要结局
Number of participants with ovarian hyperstimulation syndrome (OHSS)
时间窗: every week for eight weeks
Diagnosis of OHSS was made according to the criteria of Golan et al.. Mild OHSS was classified as: Grade 1 (abdominal distension and discomfort) and Grade 2 (features of grade 1 plus nausea, vomiting and/or diarrhea; ovaries are enlarged from 5 to 12 cm), moderate OHSS as Grade 3 (features of mild OHSS plus ultrasonic evidence of ascites), severe OHSS as Grade 4 (features of moderate OHSS plus evidence of ascites and/or hydrothorax and breathing difficulties) and Grade 5 (all of the above, plus change in the blood volume, increased blood viscosity due to hemoconcentration, coagulation abnormality, and diminished renal perfusion and function).
次要结局
- pregnancy rate(14 days after embryos transfer)
研究者
khalid abd aziz mohamed
lecturer of ob/gyn
Benha University