NCT01620346已完成不适用
Intracytoplasmic Morphologically Selected Sperm Injection (IMSI) Benefits in the Presence of Advanced Maternal Age: a Prospective Randomized Study
Sapientiae Institute2 个研究点 分布在 1 个国家目标入组 66 人开始时间: 2011年11月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 66
- 试验地点
- 2
- 主要终点
- Implantation rate
研究概览
简要总结
The objective of this study was to evaluate the advanced maternal age as a rationale for performing intracytoplasmic morphologically selected sperm injection (IMSI).
This prospective randomized study included couples undergoing intracytoplasmic sperm injection (ICSI) as a result of advanced maternal age (≥ 37 years old). Couples were randomly allocated to receive one of two sperm selection procedures (ICSI, n = 33; or IMSI, n = 33). The groups were compared with regard to fertilization rate, percentage of high-quality embryos, implantation, pregnancy and miscarriage rates.
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 (Participant)
入排标准
- 年龄范围
- 37 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Good physical and mental health
- •Advanced maternal age (≥ 37 years old)
- •Regular menstrual cycles of 25-35 days
- •Normal basal FSH and LH levels
- •Body mass index less than 30 kg/m2
- •Presence of both ovaries
- •Intact uterus
- •No hormone therapy for at least 60 days preceding the study
排除标准
- •Polycystic ovaries
- •Endometriosis
- •Gynaecological/medical disorders
- •Positive result in a screening for sexually transmitted diseases
结局指标
主要结局
Implantation rate
时间窗: 6 weeks after embryo transfer
Number of embryos implanted in the uterus divided for the number of embryos transferred.
次要结局
未报告次要终点
研究者
研究点 (2)
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