Does Intravenous Calcium Infusion Effectively Prevent OHSS : a Randomised Controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- OHSS rate
研究概览
简要总结
There are many protocols for prevention of ovarian hyperstimulation syndrome, intravenous calcium is a novel protocol. But still there is lack of evidence of it is real effect in prevention of OHSS & the mechanism of its action is still questionable . In the study the investigators try to search for the evidence for its effect & the real mechanism for its action.
详细描述
The study population will be divided into 2groups each containing 100 infertile couples candidate for ICSI.
Group (A)active group: administration of 10% Intravenous calcium gluconate 10 ml in 200 mL of physiologic saline on the day of ovum pickup, day 1,day 2, and day 3 after ovum pickup. Intravenous infusion was performed within 30 minutes.
Group (B): placebo group: administration of 200 mL of 0.9% saline on the day of ovum pickup, day 1,day 2, and day 3 after ovum pickup. Intravenous infusion was performed within 30 minutes
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 38 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •infertile women aged 20 to 38 years.
- •BMI ranged from 18 to
- •serum FSH within normal limits( 1-12IU /l)
- •presented with ovarian response suggestive of being at risk of developing OHSS because of the presence of at least 15 follicles of 10 mm or greater on the day of hCG administration.
排除标准
- •endocrinopathies.
- •a systemic disease.
- •using any medication (e.g., insulin-sensitizing drugs and GnRH antagonists.
- •patients need coasting for high risk of OHSS.
- •patients need cycle cancellation.
- •severe male infertility requiring testicular sperm extraction.
研究组 & 干预措施
saline
0.9% saline intravenous infusion
干预措施: 0.9 % saline (Drug)
calcium
Calcium intravenous infusion
干预措施: calcium (Drug)
结局指标
主要结局
OHSS rate
时间窗: 2 years
ovarain hyperstimulation syndrome
次要结局
- clinical pregnancy rate(2 years)