Effect of Albumin and Furosemide Combination for Prevention of Severe Ovarian Hyperstimulation Syndrome in Hyper-Responders Undergoing Intracytoplasmic Sperm Injection Cycles: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Incidence of Ovarian Hyperstimulation Syndrome
研究概览
简要总结
This study aims to evaluate whether the combination of Albumin and Furosemide can reduce the risk of Ovarian Hyperstimulation Syndrome in women undergoing intracytoplasmic sperm injection (ICSI) who are at high risk of developing this condition.
Ovarian hyperstimulation syndrome is a potential complication of ovarian stimulation during assisted reproductive techniques, which can lead to symptoms such as abdominal swelling, fluid accumulation, and, in severe cases, hospitalization. Preventing this condition is important to improve patient safety and treatment outcomes.
In this randomized controlled study, eligible women undergoing ICSI were assigned to receive either the combination of albumin and furosemide or standard care. The study compared the occurrence and severity of OHSS between the two groups.
The results of this study may help identify an effective strategy to prevent OHSS and improve the safety of assisted reproductive treatments.
详细描述
This is a randomized controlled clinical trial conducted in women undergoing intracytoplasmic sperm injection (ICSI) who are at high risk of developing ovarian hyperstimulation syndrome (OHSS). Participants were randomly allocated into study groups to receive either a combination protocol of albumin and furosemide or standard care.
The study was designed to evaluate the effectiveness of this intervention in reducing the incidence and severity of OHSS. Ovarian hyperstimulation syndrome is a potentially serious complication of controlled ovarian stimulation in assisted reproductive techniques and may result in abdominal distension, fluid accumulation, and hospitalization in severe cases.
The Primary Outcome:
• Incidence of moderate and severe OHSS within 14 days post oocyte retrieval
The Secondary Outcomes:
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
- None
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
- •- The inclusion criteria were females aged ≤35 years old, previous history of severe OHSS, AMH> 3.4, antral follicles count ≥22, presence of >18 follicles with a diameter >11 mm at any day of the stimulation cycle, serum estradiol ≥3500 pg/ml at day of hCG trigger, and aspiration of >15 oocytes at day of oocyte pick up.
排除标准
- •Any female who does not meet those criteria were excluded
研究组 & 干预措施
Albumin + Furosemide
Participants receive intravenous human albumin (20%, 100 mL) immediately after oocyte retrieval, followed by intravenous furosemide (20 mg), in addition to standard luteal phase support.
干预措施: Albumin (Human) 20% (Drug)
Control Arm
Participants receive standard luteal phase support only.
干预措施: Standard luteal phase support (Drug)
Albumin + Furosemide
Participants receive intravenous human albumin (20%, 100 mL) immediately after oocyte retrieval, followed by intravenous furosemide (20 mg), in addition to standard luteal phase support.
干预措施: Furosemide (Drug)
Albumin + Furosemide
Participants receive intravenous human albumin (20%, 100 mL) immediately after oocyte retrieval, followed by intravenous furosemide (20 mg), in addition to standard luteal phase support.
干预措施: Standard luteal phase support (Drug)
结局指标
主要结局
Incidence of Ovarian Hyperstimulation Syndrome
时间窗: From oocyte retrieval until 14 days after embryo transfer= 14 days
Number of participants who develop ovarian hyperstimulation syndrome after ICSI in each study group.
Incidence of Moderate and Severe Ovarian Hyperstimulation Syndrome
时间窗: Within 14 Days Post Oocyte Retrieval
Defined according to standard OHSS classification criteria
次要结局
- Incidence of mild OHSS(14 days from ova pick up)
研究者
Mufeda Ali Jwad
Principal Investigator
Al-Nahrain University