Dual Trigger in the Final Oocyte Maturation in Poor Ovarian Responders: A Prospective Randomized Controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- Number of mature oocytes (oocyte maturation rate)
研究概览
简要总结
This is a randomized controlled clinical trial to investigate the effect of dual trigger (hCG and GnRH agonist) on the final oocyte maturation compared to the standard hCG trigger in patients with poor ovarian reserve seeking IVF/ICSI treatment.
详细描述
Women with POR (Bologna criteria) manifest a very low follicular response to controlled ovarian stimulation irrespective of the stimulation protocol utilized. Dual triggering of oocyte maturation was shown to improve follicle collection yield and oocyte maturation in women with predicted normal ovarian response. These benefits have been attributed to the GnRHa-induced FSH surge believed to promote oocyte nuclear maturation and cumulus expansion. The aim of the study is to show whether the co-administration of a GnRH agonist and hCG for final oocyte maturation improve oocyte collection and maturation rate
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 44 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Normal uterine cavity (as assessed by hysteroscopy or HSG).
- •Normal hormonal investigation: TSH, PRL.
- •Low ovarian reserve patients (AMH<1.5ng/ml, AFC of 7 or less, 5 oocytes or less retrieved in a previous cycle)
排除标准
- •Abnormal uterine cavity (Hysteroscopy or HSG)
- •Evidence of untreated endocrine disorders (abnormal TSH, prolactin, testosterone and androstenedione concentrations)
研究组 & 干预措施
Dual trigger
Dual trigger: (0.3 mg GnRHa = triptorelin) with + HCG (Choriomon)10 000 IU . will be administered subcutaneously in a single dose 0.3 mg with 10 000 HCG when at least 2 follicles 18 mm in diameter have been observed by ultrasound examination.
干预措施: Dual trigger (Drug)
hCG (standard)
HCG (Choriomon) of 10 000 IU will be administered subcutaneously in a single dose when at least 2 follicles 18 mm in diameter have been observed by ultrasound examination.
干预措施: hCG (standard) (Drug)
结局指标
主要结局
Number of mature oocytes (oocyte maturation rate)
时间窗: 38 hrs
the ratio of MII oocytes to the number of collected oocytes
Number of oocytes retrieved (oocyte collection rate)
时间窗: 38 hrs
the total number of oocytes retrieved divided by the number of follicles aspirated (diameter ≥10 mm) on the day of oocyte retrieval
次要结局
- Clinical pregnancy rate(7 weeks)
- Implantation rate(7 weeks)
- Miscarriage rate(12 weeks)
- Fertilization rate(48 hrs)