The Randomized Clinical Trials of Letrozole Administration During Luteal Phase in Patients Who Have the Risk of Ovarian Hyperstimulation Syndrome
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- The incidence of early OHSS
研究概览
简要总结
To investigate the effect of letrozole in patients who have high risk of ovarian hyperstimulation syndrome (OHSS) after oocyte retrieval, the incidence of OHSS were calculated between letrozole group and supporting treatment group.
详细描述
- Object:
Infertility patients who frozen all embryos due to the risk of OHSS were randomized allocated to letrozole or polygeline injection group. Inclusion criteria meet one of the following conditions: (1) oocyte is more than or equal to 20; (2) human chorionic gonadotropin (hCG) injection on serum estradiol levels greater than or equal to 5000 pmol/L; (3) on the day of oocyte unilateral or bilateral ovarian diameter greater than or equal to 10 cm (4) follicle puncture is larger than or equal to number 20. After the informed consent was signed, letrozole or polygeline injection was randomized allocated after oocyte retrieval. OHSS was determined according to Golan diagnosis standards. 2. Clinical data:
Including age, infertility duration, body mass index (BMI), basic follicle-stimulating hormone (FSH) and luteinizing hormone (LH), antral follicle number (AFC), Gn dosage, estradiol level on hCG injection day, the number of oocytes, the number of embryos, early onset OHSS incidence, and the existence of ascites. 3. Reproductive hormone levels:
1, 4, 7, days after taken letrozole, and the supernatant was collected for serum reproductive hormone test.
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 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Polygeline Injection
500ml and 0.9% Sodium Chloride Injection (250ml) with dexamethasone 1mg intravenous injection，once a day for 2 days
干预措施: dexamethasone (Drug)
letrozole
2.5mg/tablet(Jiangsu Hengrui Medicine Co., Ltd. products), orally taken 5mg once a day for 5 days
干预措施: Letrozole (Drug)
Polygeline Injection
500ml and 0.9% Sodium Chloride Injection (250ml) with dexamethasone 1mg intravenous injection，once a day for 2 days
干预措施: Polygeline (Drug)
Polygeline Injection
500ml and 0.9% Sodium Chloride Injection (250ml) with dexamethasone 1mg intravenous injection，once a day for 2 days
干预措施: Sodium Chloride (Drug)
结局指标
主要结局
The incidence of early OHSS
时间窗: one year
次要结局
未报告次要终点