Development of IVF/ICSI Children Born From Different Endometrial Preparation Protocols
- Conditions
- Endometrial PreparationChild Development
- Interventions
- Diagnostic Test: Developmental score according to The Ages & Stages Questionnaires®, Third Edition - ASQ®-3Other: Physical development and General HealthDiagnostic Test: Developmental Red flags
- Registration Number
- NCT05502770
- Lead Sponsor
- Mỹ Đức Hospital
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 700
- 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.
- Babies died under or at 24 months
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Natural cycle children Developmental score according to The Ages & Stages Questionnaires®, Third Edition - ASQ®-3 Children born from frozen embryo transfer with natural cycle protocol Natural cycle children Physical development and General Health Children born from frozen embryo transfer with natural cycle protocol Modified natural cycle children Physical development and General Health Children born from frozen embryo transfer with modified natural cycle protocol Artificial cycle children Physical development and General Health Children born from frozen embryo transfer with artificial cycle protocol Natural cycle children Developmental Red flags Children born from frozen embryo transfer with natural cycle protocol Artificial cycle children Developmental score according to The Ages & Stages Questionnaires®, Third Edition - ASQ®-3 Children born from frozen embryo transfer with artificial cycle protocol Modified natural cycle children Developmental score according to The Ages & Stages Questionnaires®, Third Edition - ASQ®-3 Children born from frozen embryo transfer with modified natural cycle protocol Modified natural cycle children Developmental Red flags Children born from frozen embryo transfer with modified natural cycle protocol Artificial cycle children Developmental Red flags Children born from frozen embryo transfer with artificial cycle protocol
- Primary Outcome Measures
Name Time Method The average total ASQ-3 score 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.
- Secondary Outcome Measures
Name Time Method Score of Fine motor Up to 24 months after birth 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
Score of Personal-Social Up to 24 months after birth 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
Score of Gross motor Up to 24 months after birth 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
The rate of children who have at least one red flag sign From 6 months to 24 months after birth 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.Score of Communication Up to 24 months after birth 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
Score of Problem solving Up to 24 months after birth 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
Trial Locations
- Locations (1)
My Duc Hospital
🇻🇳Ho Chi Minh City, Vietnam