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临床试验/NCT05502770
NCT05502770招募中不适用

Development of IVF/ICSI Children Born From Frozen Embryo Transfer Cycles With Different Endometrial Preparation Protocols: Follow-up of a Randomized Controlled Trial

Mỹ Đức Hospital1 个研究点 分布在 1 个国家目标入组 700 人开始时间: 2022年8月12日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
700
试验地点
1
主要终点
The average total ASQ-3 score

研究概览

简要总结

The efficacy and safety of endometrial preparation regimens remain controversial. In the most recent meta-analysis, using natural and modified natural cycle protocol to prepare the endometrium in frozen embryo transfer resulted in higher live birth rates. In addition, the natural cycle reduces the risk of gestational hypertension, postpartum haemorrhage, and extremely preterm delivery compared with regimens using exogenous hormones.

Because there are many physiological and endocrinal differences in the frozen embryo transfer cycle with different endometrial preparation protocols, the development of children born from these regimens has received much attention. For example, there is a complete absence of the corpus luteum during the cycle of exogenous hormone administration. Or in the modified natural cycle, the pharmacokinetics is not entirely the same as the natural physiology when using an additional ovulatory injection with hCG. To date, there have been no longitudinal follow-up studies that evaluated and compared the long-term development of IVF/ICSI children born from frozen embryo transfer with different endometrial preparation protocols.

Thus, the investigators conduct a follow-up of our RCT to investigate the IVF/ICSI children born from frozen embryo transfer with different endometrial preparation protocols to give strong evidence about the safety of the three most common endometrial preparation protocols in women undergoing frozen embryo transfer.

详细描述

Developing further from a previous randomized controlled clinical trial (MONART study - NCT04804020), the investigators decided to assess the physical, mental, and motor development of children up to 24 months after birth, with the aim of providing additional information on the safety of these regimens on the long-term health of the IVF/ICSI children.

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
6 Months 至 18 Months(Child)
性别
All
接受健康志愿者

入选标准

  • All live IVF/ICSI babies born from frozen embryo transfer following the natural cycle, modified natural cycle, and artificial cycle from MONART study
  • Parents agree to participate in the study.

排除标准

  • Babies died under or at 24 months

结局指标

主要结局

The average total ASQ-3 score

时间窗: Up to 24 months after birth

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 average = average score of 5 aspects.

次要结局

  • Score of Fine motor(Up to 24 months after birth)
  • Score of Personal-Social(Up to 24 months after birth)
  • Score of Gross motor(Up to 24 months after birth)
  • The rate of children who have at least one red flag sign(From 6 months to 24 months after birth)
  • Score of Communication(Up to 24 months after birth)
  • Score of Problem solving(Up to 24 months after birth)

研究者

发起方
Mỹ Đức Hospital
申办方类型
Other
责任方
Sponsor

研究点 (1)

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