Epigenetic Safety of Various Protocols in Assisted Reproductive Technology
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 15,000
- 试验地点
- 1
- 主要终点
- live birth rate
研究概览
简要总结
The primary purpose of the study is to investigate the relationship between different protocols of assisted reproductive technology and the epigenetic safety of the offspring. Different interventions of assisted reproductive technology include controlled ovarian hyperstimulation (COH), in vitro embryo culture, in vitro fertilization(IVF), intracytoplasmic sperm injection(ICSI), frozen-thawed embryo transfer(FET), preimplantation genetic testing(PGT). The investigators are also interested in the relationship between pregnancy outcomes in ART or natural conception and environmental, nutritional and lifestyle factors.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 20 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Couples undergoing treatment for infertility or getting pregnant naturally and wanting to deliver their babies in Women's Hospital School of Medicine Zhejiang University, The International Peace Maternity & Child Health Hospital, and Changhai Hospital of Shanghai.
- •Men 22-55 years old
- •Women 20 - 45 years old
排除标准
- •Any individual or couple who is outside of age range .
- •Any couple who don't plan to complete their pregnancy check-up or deliver their babies in Women's Hospital School of Medicine Zhejiang University, The International Peace Maternity & Child Health Hospital, or Changhai Hospital of Shanghai.
结局指标
主要结局
live birth rate
时间窗: 1 day after delivery
Number of women with live births / number of women randomized to the specific group.Live birth is defined as the delivery of any viable infant at 28 weeks or more of gestation after our interventions.
birth weight
时间窗: 1 day after delivery
Weight of newborns at delivery.
implantation rate
时间窗: 11-12 weeks after embryo transfer
Implantation rate was defined as the percentage of fetal heart beat among total transferred embryos at 12 weeks' gestational age.
congenital anomalies rate
时间窗: 1 day after delivery
Congenital anomaly included deformity and development abnormality of any organs or systems.
weight
时间窗: Change from the date of delivery up to 4 years after delivery
the weight of offspring
Incidence of mental diseases and metabolic dysfunction
时间窗: 4 years after delivery
clinical pregnancy rate
时间窗: 6 weeks after embryo transfer
Clinical pregnancy was defined as an observation of gestational sac via ultrasonography.
height
时间窗: Change from the date of delivery up to 4 years after delivery
the height of offspring
次要结局
- Incidence of moderate to severe ovarian hyperstimulation syndrome(OHSS)(3 months after controlled ovarian hyperstimulation)
- ectopic pregnancy rate(12 gestational weeks in maximum)
- preterm birth rate(28 gestational weeks to 37 gestational weeks)
- biochemical pregnancy rate(2 weeks after embryo transfer)
- pregnancy loss rate(28 gestational weeks in maximum)
- neonatal complication rate(1 day after delivery)
研究者
Dan Zhang
Principal Investigator
Women's Hospital School Of Medicine Zhejiang University