NCT03823235已完成不适用
Humidified Incubator Effect on Live Birth Rate After ICSI
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,837
- 试验地点
- 3
- 主要终点
- Live birth rate
研究概览
简要总结
Humidity for human embryo culture has been raised as essential with advantageous effect on clinical pregnancy and ongoing pregnancy after ICSI compared with a dry incubator. Whether the deleterious effect of dry culture would have an extended effect reaches the live birth rate needs to be examined. This RCT is to examine the effect of dry and humidified culture on live birth rates after ICSI.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women undergoing a first or second ICSI attempts
- •Primary or secondary infertility with a BMI of < 31 kg/m2
- •Duration of infertility of ≥ 18 months and normal baseline ultrasonography
- •18 to 40 years of age
- •Tubal factor, male factor, polycystic ovary, unexplained infertility or combined factors
- •Tubal factors
排除标准
- •Surgically-retrieved, frozen-thawed and pinpoint sperm or globozoospermia
- •Thin endometrium
- •Uterine anomaly and adhesion
- •Adenomyosis
- •Submucous myoma
- •Endometriosis
- •Severe medical condition
研究组 & 干预措施
Culture of human embryo in non-humidified incubator
Experimental
Embryo culture after in vitro fertilization in incubator with no humidity
干预措施: Human embryo culture (Other)
Culture of human embryo in humidified incubator
No Intervention
Embryo culture after in vitro fertilization in incubator with humidity
结局指标
主要结局
Live birth rate
时间窗: 30 weeks
Viable neonate after 30 weeks of gestation per initiated cycle
次要结局
- Cumulative ongoing pregnancy rate(12 weeks of gestation)
- Preterm birth rate(37 weeks)
- Cleavage rate(6 days of culture)
- Blastocyst formation rate(6 days of culture)
- Rate of high-quality blastocyst(6 days of culture)
- Ongoing pregnancy rate(12 weeks of gestation)
- Implantation rate(7 weeks of gestation)
- Ongoing implantation rate(12 weeks of gestation)
- Fertilization rate(6 days of culture)
- Rate of high-quality day-3 embryos(6 days of culture)
- Rate of utilizable blastocyst(6 days of culture)
- Cumulative clinical pregnancy rate(7 weeks of gestation)
- Very preterm birth(32 weeks)
- Low birth weight rate(40 weeks of gestation)
- Cumulative live birth rate(One year)
- Clinical pregnancy rate(7 weeks of gestation)
- Cumulative implantation rate(7 weeks of gestation)
- Cumulative ongoing implantation rate(12 weeks of gestation)
研究者
Muhammad Fawzy
Lab Director
Ibn Sina Hospital
研究点 (3)
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