NCT02358733终止不适用
Use of Intra-Cytoplasmic Morphologically Selected Sperm Injection (IMSI) in Poor Responders to In Vitro Fertilization (IVF): a Prospective, Double-blind, Randomized, Controlled Trial
Centro de Infertilidad y Reproducción Humana2 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2015年2月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Clinical pregnancy rate
研究概览
简要总结
This is a pilot study which aims to determine the role of IMSI in poor responders.
详细描述
This is a pilot study which aims to determine the role of IMSI over ICSI in poor responders to IVF, without a background of teratozoospermia.
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
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 37 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •poor ovarian response
排除标准
- •body mass index (BMI) ≥ 30 kg/m2
- •presence of endocrinopathies (e.g., diabetes, hyperprolactinemia, hypothyroidism)
- •altered karyotype or documented genetic defects in one or both partners
- •history of chronic, autoimmune or metabolic diseases
- •altered meiosis in testicular biopsy or altered sperm-FISH
- •teratozoospermia
- •participation, simultaneously or within the previous 6 months, in another clinical trial with medication
研究组 & 干预措施
Treatment
Experimental
Intra-cytoplasmic Morphologically-selected Sperm Injection (IMSI)
干预措施: Intra-cytoplasmic Morphologically-selected Sperm Injection (Procedure)
Control
Active Comparator
Intracytoplasmic sperm injection (ICSI)
干预措施: Intra-cytoplasmic Sperm Injection (Procedure)
结局指标
主要结局
Clinical pregnancy rate
时间窗: Four to six weeks after embryo transfer
Percentage of patients presenting with presence of an intrauterine gestational sac with embryonic cardiac activity display, evaluated by ultrasound, per cycle initiated
次要结局
- Number of embryos obtained(Two days after egg retrieval)
- Percentage of cycles with embryo transfer(Two days after egg retrieval)
研究者
研究点 (2)
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