Comparison of Treatment Modalities in Poor Responders Undergoing IVF
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Ongoing pregnancy rate
研究概览
简要总结
The accurate identification and efficient management of poor responders remains one of the most enigmatic challenges in assisted reproductive technology (ART). The investigators study will compare the letrozole/antagonist protocol to the hMG/antagonist protocol in women who poor responders.
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
- None
入排标准
- 年龄范围
- 18 Years 至 42 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients will be considered eligible if they are poor ovarian responders according to the Bologna criteria (Ferraretti et al., 2011).
- •Two out of three of the following criteria are essential in order to classify a patient as poor ovarian responder:
- •advanced maternal age (≥40 years) or any other risk factor for poor ovarian response;
- •a poor ovarian response (≤3 oocytes with a conventional stimulation protocol); or
- •an abnormal ovarian reserve test (antral follicle count, <7 follicles or anti-Mullerian hormone, <1.1 ng/ml).
排除标准
- 未提供
研究组 & 干预措施
human menopausal gonadotropin (hMG)
hMG at a dose of 300 IU/day will be initiated on the second or third day of spontaneous menstruation and continued until the day of ovulation triggering. Ovulation triggering will be performed with the administration of 10000 IU of human chorionic gonadotropin (hCG) as soon as two-three follicles of 17 mm diameter will be observed by transvaginal ultrasound.
干预措施: human menopausal gonadotropin (hMG) (Drug)
Letrozole
Letrozole (Femara; Novartis, East Hanover, NJ) at a dose of 5 mg/day will be initiated on the second or third day of spontaneous menstruation and continued for 5 days. Again on the second or third day of spontaneous menstruation, 150 IU of hMG will be started until the day of ovulation triggering. Ovulation triggering will be performed with the administration of 10000 IU of hCG as soon as two-three follicles of 17 mm diameter will be observed by transvaginal ultrasound.
干预措施: Letrozole (Drug)
结局指标
主要结局
Ongoing pregnancy rate
时间窗: up to 2 weeks
The primary outcome measure will be the ongoing pregnancy rate (\>12 weeks' gestation) per started cycle.
次要结局
- Clinical pregnancy rate(up to 2 weeks)
- Cancellation Rate(up to one month)
- Number of oocytes retrieved(up to one month)
- Number of transferable embryos(up to one month)
- Implantation rate(up to 2 weeks)
研究者
Ercan Bastu
Associate Professor of Obstetrics and Gynecology
Istanbul University