Long-term Developmental and Behavioral Outcomes of Children Born From CAPA-IVM Versus Conventional IVF at 5-year-old
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 214
- 试验地点
- 1
- 主要终点
- Normal ASQ-3 score rate.
研究概览
简要总结
The investigators conduct a long-term follow-up at five years on offspring born from our randomized controlled trial (RCT) to investigate whether or not there is any difference in developmental outcomes in children born after capacitation IVM (CAPA IVM) compared with conventional IVF in order to give strong evidence about the safety of IVM in women with high antral follicle count.
详细描述
The safety of the CAPA-IVM has also been proven by publications about the development of children born from this technique.
Data monitoring the physical, mental, and motor development of children born from the CAPA-IVM versus children born from the conventional IVF after 2 years under using the ASQ-3 tools and red flags showed that there were no significant differences in ASQ-3 scores at 6, 12 and 24 months between children born after IVM or IVF. The proportion of children with developmental red flags was low and did not differ between the two groups. Slightly, but significantly, lower ASQ-3 problem-solving and personal-social scores in twins from the IVM versus IVF group at 6 months were still within the normal range and had caught up to the IVF group in the 12- and 24-month assessments.
However, another question raised is whether there is a difference in the development of children born from CAPA-IVM compared to conventional IVF after a longer follow-up period. Does the development between the two groups have a clinically significant difference? Based on these questions, we decided to conduct an assessment of the physical, behavioural, mental, and motor development of children born from CAPA-IVM and conventional IVF up to 5 years after birth.
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
- 5 Years 至 5 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All babies born following the In-vitro Maturation and In-vitro fertilization from our FM study (NCT03405701) participated in our previous follow-up study (NCT04296357)
- •Parents agree to participate in the study.
排除标准
- •Babies died under or at 60 months
结局指标
主要结局
Normal ASQ-3 score rate.
时间窗: Up to 5 years after birth
A normal ASQ-3 score is the child's total score for each area above the cutoff. ASQ-3 (Ages and Stages Questionaires®) has 5 aspects: Communication, Gross motor, Fine motor, Problem solving, and Personal-Social Each aspect has 6 questions, if the answer is Yes, score = 10, Sometimes = 5 and Not yet = 0. ASQ-3 score = total area scores.
Normal weight rate
时间窗: Up to 5 years after birth
Normal weight is a BMI greater than or equal to -2 standard deviations and less than or equal to 1 standard deviation of the WHO growth reference median.
Normal SDQ score rate.
时间窗: Up to 5 years after birth
Normal SDQ score is defined as the total score of each area out of the abnormal range for each one. Abnormal range for each area is described as below: 1. emotional symptoms: from 5 to 10 2. conduct problems: from 4 to 10 3. hyperactivity/inattention: from 7 to 10 4. peer relationship problems: from 4 to 10 5. prosocial behaviour: from 0 to 4 6. The total difficulties score: from 17 to 40
次要结局
- Score of Gross motor (ASQ-3 questionnaire)(Up to 5 years after birth)
- Overweight rate(Up to 5 years after birth)
- Score of Communication (ASQ-3 questionnaire)(Up to 5 years after birth)
- Score of Fine motor (ASQ-3 questionnaire)(Up to 5 years after birth)
- Score of Conduct problems (SDQ questionnaire)(Up to 5 years after birth)
- Thinness rate(Up to 5 years after birth)
- Score of Emotional symptoms (SDQ questionnaire)(Up to 5 years after birth)
- The total difficulties score.(Up to 5 years after birth)
- Obesity rate(Up to 5 years after birth)
- Score of Problem solving (ASQ-3 questionnaire)(Up to 5 years after birth)
- Score of hyperactivity/inattention (SDQ questionnaire)(Up to 5 years after birth)
- Score of prosocial behavior (SDQ questionnaire)(Up to 5 years after birth)
- Score of Personal-Social (ASQ-3 questionnaire)(Up to 5 years after birth)
- Score of peer relationship problems (SDQ questionnaire)(Up to 5 years after birth)