Physical, Mental, and Motor Development of Children Born From Intracytoplasmic Sperm Injection With Assisted Oocyte Activation With Calcium Ionophore
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 63
- 试验地点
- 1
- 主要终点
- The percentage of abnormal ASQ-3 score
研究概览
简要总结
The investigators follow up on the development of children born from ICSI-AOA using the Developmental Red Flags and Ages & Stages Third Edition (ASQ-3) Questionnaires to give strong evidence about the safety of AOA in assisted reproductive technology.
详细描述
Intracytoplasmic sperm injection (ICSI) is the most widely utilized assisted reproductive technique (ART) worldwide. Fertilization rates obtained after ICSI treatment are reported between 70 and 80%, representing the most efficient ART; however, complete post-ICSI fertilization failure still occurs in 3-5% of cases.
The leading cause of failed fertilization is failure to achieve oocyte activation, a crucial stage in the initiation of embryo development during fertilization. Assisted oocyte activation (AOA) using a calcium ionophore has been used for over a decade following ICSI fertilization failure. AOA is not considered a routine practice of ART yet, which is only suitable for patients with proper indications, including (i) total fertilization failure or low fertilization rate (<30%) in the previous IVF; (ii) severe male factor infertility; (iii) patients with a history of embryo arrest or poor embryo quality in previous IVF cycle.
Regarding technique, the artificial rise of induced calcium rises cannot precisely mimic the physiologically sperm-induced calcium oscillations. Little is known yet about the possible adverse effects of ionophores on post-implantation embryo development. Numerous studies have been conducted to compare the development of children born from ICSI - AOA versus non-AOA. Thus, the investigators performed this study to investigate the physical, mental, and motor development of children born following ICSI - AOA using the Developmental Red Flags and Ages & Stages Third Edition (ASQ-3) Questionnaires.
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
- 12 Months 至 12 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All single, live babies born following ICSI with AOA and ICSI without AOA from 08/2020 to 04/
- •Parents consent to participate in the study. Group ICSI+AOA: Embryos from ICSI with AOA with calcium ionophore
- •In the ICSI+AOA group, indications of AOA are:
- •Previous failed IVF treatment with no fertilization or poor fertilization rate (fertilized oocytes/pick-up oocytes<35%) or poor embryo result (number of embryos/pick-up oocytes<35%, <3 embryos, no good-quality embryo)
- •Using sperm after retrieval technique, cryptozoospermia Group Control: Embryos from ICSI without AOA.
- •In the Control group, the indications of AOA for the next IVF cycle (if patients continue the next IVF cycle) are:
- •Currently failed IVF treatment with no fertilization or poor fertilization rate (fertilized oocytes/pick-up oocytes<35%) or poor embryo result (number of embryos/pick-up oocytes<35%, <3 embryos, no good-quality embryo)
排除标准
- •Embryos with PGT. Oocyte donation
结局指标
主要结局
The percentage of abnormal ASQ-3 score
时间窗: 12 months after birth
ASQ-3 (Ages and Stages Questionaires®) has 5 aspects: Communication, Gross Motor, Fine Motor, Problem-solving, and Personal-Social Each element has 6 questions. If the answer is Yes, score = 10, Sometimes = 5, and Not yet = 0. ASQ-3 average = average score of 5 aspects.
次要结局
- Score of Personal-Social(12 months after birth)
- Number of hospital admission(12 months after birth)
- Score of Problem-solving skill(12 months after birth)
- The rate of children who have at least one red flag sign(s):(12 months after birth)
- Duration of breastfeeding(12 months after birth)
- Score of Communication(12 months after birth)
- Score of Gross motor(12 months after birth)
- Score of Fine motor(12 months after birth)
- Name of diseases that lead to hospital admission(12 months after birth)
- Weight(12 months after birth)
- Infant age at which weaning starts(12 months after birth)
- Height(12 months after birth)