Ignite Creation Date:
2024-05-06 @ 8:24 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06369415
Status:
RECRUITING
Last Update Posted:
2024-04-17
First Post:
2024-04-11
Brief Title:
Health of Babies Born From IVF Versus IVM at 5 Years Old
Sponsor:
Mỹ Đức Hospital
Organization:
Mỹ Đức Hospital
Study Overview
Official Title:
Long-term Developmental and Behavioral Outcomes of Children Born From CAPA-IVM Versus Conventional IVF at 5-year-old
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
FM-BABIES-5Y
Brief Summary:
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
Detailed Description:
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None