Among ICSI Patients Undergoing Antagonist Protocols With Recombinant FSH, Does Replacement of Recombinant FSH by 200 IU of hCG in the Late Follicular Phase Compared With Continuing Recombinant FSH, Result in a Similar Number of Oocytes?
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Number of oocytes in both treatment groups
研究概览
简要总结
In this study,the investigators compared two protocols for controlled ovarian hyperstimulation in infertility patients requiring IVF. In the control group, the patient undergoes a standard antagonist protocol. In the study group, the administration of gonadotropins is stopped in the late follicular phase and replaced by low dose human chorionic gonadotropins. The primary endpoint of the study is the number of oocytes retrieved in both groups.
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
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 36 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •< 36 years on day of randomisation
- •FSH < 12 in the early follicular phase
- •Normal ultrasound scan
- •BMI between 18 and 29 (both inclusive)
- •Randomisation at outpatient clinic
排除标准
- •Endometriosis ≥ grade 3
- •PCO syndrome
- •Poor responder
- •Endocrine or metabolic abnormalities
研究组 & 干预措施
A
Patients undergo a standard antagonist protocol for in-vitro fertilisation, and are stimulated with recombinant gonadotropins.
干预措施: recombinant gonadotropins (Drug)
B
Patients are undergo an antagonist protocol for in-vitro fertilisation and are stimulated with recombinant gonadotropins. When the patient has an estradiol value of 600 ng/L or more and when the patient has at least 6 follicles of 12 mm, the administration of gonadotropins is stopped and replaced by low dose human chorionic gonadotropins.
干预措施: human chorionic gonadotropin (Drug)
结局指标
主要结局
Number of oocytes in both treatment groups
时间窗: up to 9 months
次要结局
- Duration of stimulation in both treatment groups, amount of gonadotropins consumed in each treatment group(up to 9 months)