Child Development Clinical Trial
— MONARTBABIESOfficial title:
Development of IVF/ICSI Children Born From Frozen Embryo Transfer Cycles With Different Endometrial Preparation Protocols: Follow-up of a Randomized Controlled Trial
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.
Status | Recruiting |
Enrollment | 700 |
Est. completion date | November 2024 |
Est. primary completion date | June 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 6 Months to 18 Months |
Eligibility | Inclusion Criteria: - 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. Exclusion Criteria: - Babies died under or at 24 months |
Country | Name | City | State |
---|---|---|---|
Vietnam | My Duc Hospital | Ho Chi Minh City |
Lead Sponsor | Collaborator |
---|---|
M? Ð?c Hospital |
Vietnam,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The average total ASQ-3 score | 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. |
Up to 24 months after birth | |
Secondary | Score of Communication | 6 questions, if the answer is Yes, score = 10, Sometimes = 5 and Not yet = 0. Total score will be used: minimum = 0 and maximum = 60. Each aspects in each stages has alternative threshold | Up to 24 months after birth | |
Secondary | Score of Gross motor | 6 questions, if the answer is Yes, score = 10, Sometimes = 5 and Not yet = 0. Total score will be used: minimum = 0 and maximum = 60. Each aspects in each stages has alternative threshold | Up to 24 months after birth | |
Secondary | Score of Fine motor | 6 questions, if the answer is Yes, score = 10, Sometimes = 5 and Not yet = 0. Total score will be used: minimum = 0 and maximum = 60. Each aspects in each stages has alternative threshold | Up to 24 months after birth | |
Secondary | Score of Problem solving | 6 questions, if the answer is Yes, score = 10, Sometimes = 5 and Not yet = 0. Total score will be used: minimum = 0 and maximum = 60. Each aspects in each stages has alternative threshold | Up to 24 months after birth | |
Secondary | Score of Personal-Social | 6 questions, if the answer is Yes, score = 10, Sometimes = 5 and Not yet = 0. Total score will be used: minimum = 0 and maximum = 60. Each aspects in each stages has alternative threshold | Up to 24 months after birth | |
Secondary | The rate of children who have at least one red flag sign | He or she has at least one red flag sign by age. For children at 6 months: he or she Lack of turning toward voices. Does not pass object from one hand to another. No smiling, laughing, or expression.
For children at 12 months: he or she Child does not respond to name. Does not understand "no". Does not stand or bear weight on legs when supported. Indifferent or resistant attachment to caregiver. Does not look where caregiver points. For children at 18 months: he or she has Not using at least 6 words. Inability to walk independently. Absence of proto-imperative pointing (point to show interest) or showing gesture. |
From 6 months to 24 months after birth |
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