Development of IVF/ICSI Children Born From Different Endometrial Preparation Protocols
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Developmental score according to The Ages & Stages Questionnaires®, Third Edition - ASQ®-3, Physical development and General Health, Developmental Red flags.
- Who it may be relevant to
- Registry conditions: Child Development, Endometrial Preparation. Basic parameters: 6 months — 18 months · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Vietnam
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Development of IVF/ICSI Children Born From Frozen Embryo Transfer Cycles With Different Endometrial Preparation Protocols: Follow-up of a Randomized Controlled Trial
Overview
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.
Interventions
- Diagnostic test Developmental score according to The Ages & Stages Questionnaires®, Third Edition - ASQ®-3
Ages \& Stages Questionnaires®, Third Edition (ASQ®-3) is a developmental screening tool designed for use by early educators and health care professionals. It relies on parents as experts, is easy-to-use, family-friendly and creates the snapshot needed to catch delays and celebrate milestones. - Other Physical development and General Health
Physical development and General health examination - Diagnostic test Developmental Red flags
Developmental Red flags Questionnaires
Primary outcome measures
- The average total ASQ-3 score [Time frame: Up to 24 months after birth]
Secondary outcome measures (6)
- Score of Communication [Time frame: Up to 24 months after birth]
- Score of Gross motor [Time frame: Up to 24 months after birth]
- Score of Fine motor [Time frame: Up to 24 months after birth]
- Score of Problem solving [Time frame: Up to 24 months after birth]
- Score of Personal-Social [Time frame: Up to 24 months after birth]
- The rate of children who have at least one red flag sign [Time frame: From 6 months to 24 months after birth]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
Vietnam · 1 center
- My Duc Hospital — Ho Chi Minh City
Identifiers
NCT: NCT05502770 · 09/22/DD-BVMD