Clinical Study to Evaluate Efficacy of Cabergoline to Coasting in Reducing the Incidence of Ovarian Hyperstimulation Syndrome
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Occurrence and severity of OHSS
研究概览
简要总结
Ovarian hyperstimulation syndrome (OHSS) is a serious iatrogenic complication of controlled ovarian stimulation of gonadotrophin-Stimulated ovarian cycles. It is theorized to manifest systemically as a result of vasoactive mediators like vascular endothelium growth factor (VEGF) being released from hyperstimulated ovaries. As a result, capillary permeability is increased which causes the extravasation of fluid from the intravascular compartment into the third space. The haemoconcentration which ensues results in complications such as hypercoagulability and reduced end organ perfusion.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 20 Years 至 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age between 18-38 years
- •Body mass index (calculated as weight in kilograms divided by the square of height in meters) < 30 kg/m
- •A long luteal protocol is used for ovarian stimulation.
- •Day 2 FSH <10 mIU/L and E2< 50 pg/ml
- •High risk of OHSS, defined as having more than 20 follicles >12 mm in diameter and/or E2 levels > 3000 pg/ml when the size of the leading follicle is > 15 mm
排除标准
- •The presence of chronic medical diseases, including liver cell failure, renal failure, uncontrolled hypertension, uncontrolled diabetes mellitus, or class 3 or 4 function heart disease in the New York heart association classification.
- •Allergy to Cabergoline.
研究组 & 干预措施
Control group
Group 1 (coasting only): In their ICSI cycle patients will take 0.25 mg of cabergoline daily for 8 days from HCG triggering day to prevent OHSS. Early OHSS is assessed at day of embryo transfer and 7 days after this date. Late OHSS is assessed 14 days after embryo transfer.
干预措施: Coasting (Procedure)
Cabergoline group
Coasting plus cabergoline: In their ICSI cycle patients will continue their agonist treatment while stopping the human menopausal gonadotropin (hMG) injections for 1 day plus receiving 0.25 mg of cabergoline daily for 8 days from HCG triggering day to prevent OHSS. Early OHSS is assessed at day of embryo transfer and 7 days after this date. Late OHSS is assessed 14 days after embryo transfer.
干预措施: Coasting (Procedure)
Cabergoline group
Coasting plus cabergoline: In their ICSI cycle patients will continue their agonist treatment while stopping the human menopausal gonadotropin (hMG) injections for 1 day plus receiving 0.25 mg of cabergoline daily for 8 days from HCG triggering day to prevent OHSS. Early OHSS is assessed at day of embryo transfer and 7 days after this date. Late OHSS is assessed 14 days after embryo transfer.
干预措施: Cabergoline (Drug)
结局指标
主要结局
Occurrence and severity of OHSS
时间窗: 1 month
The primary outcome of this study is the occurrence and severity of OHSS. OHSS was defined as abdominal pain and distention associated with nausea and vomiting and ovarian enlargement \> 8 cm. The severity of OHSS will be assessed (mild, moderate, severe, and clinical) according to the American Society for Reproductive Medicine guidelines
次要结局
未报告次要终点