Clinical trial NCT06369415: Health of Babies Born From IVF Versus IVM at 5 Years Old
Official title: Long-term Developmental and Behavioral Outcomes of Children Born From CAPA-IVM Versus Conventional IVF at 5-year-old
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Infertility
IVF
IVM
Development, Child
Keywords: IVF
IVM
ASQ-3
childhood development
Lead sponsor: Mỹ Đức Hospital
Sponsor class: OTHER
First posted: 2024-04-17
Enrollment: 231
Sex: ALL
Minimum age (years): 5
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children participated in our previous follow-up study (NCT04296357)

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.

Eligibility criteria: Inclusion Criteria:

* All babies born following the In-vitro Maturation and In-vitro fertilization from our FM study (NCT03405701) participated in our previous follow-up study (NCT04296357)
* Parents agree to participate in the study.

Exclusion Criteria:

* Babies died under or at 60 months

Primary outcomes:
measure: Normal ASQ-3 score rate.
timeFrame: Up to 5 years after birth
measure: Normal SDQ score rate.
timeFrame: Up to 5 years after birth
measure: Normal weight rate
timeFrame: Up to 5 years after birth
Secondary outcomes:
measure: Thinness rate
timeFrame: Up to 5 years after birth
measure: Overweight rate
timeFrame: Up to 5 years after birth
measure: Obesity rate
timeFrame: Up to 5 years after birth
measure: Score of Communication (ASQ-3 questionnaire)
timeFrame: Up to 5 years after birth
measure: Score of Gross motor (ASQ-3 questionnaire)
timeFrame: Up to 5 years after birth
measure: Score of Fine motor (ASQ-3 questionnaire)
timeFrame: Up to 5 years after birth
measure: Score of Problem solving (ASQ-3 questionnaire)
timeFrame: Up to 5 years after birth
measure: Score of Personal-Social (ASQ-3 questionnaire)
timeFrame: Up to 5 years after birth
measure: Score of Emotional symptoms (SDQ questionnaire)
timeFrame: Up to 5 years after birth
measure: Score of Conduct problems (SDQ questionnaire)
timeFrame: Up to 5 years after birth
measure: Score of hyperactivity/inattention (SDQ questionnaire)
timeFrame: Up to 5 years after birth
measure: Score of peer relationship problems (SDQ questionnaire)
timeFrame: Up to 5 years after birth
measure: Score of prosocial behavior (SDQ questionnaire)
timeFrame: Up to 5 years after birth
measure: The total difficulties score.
timeFrame: Up to 5 years after birth
Other outcomes:
Locations:
city: Ho Chi Minh City
country: Vietnam
facility: Mỹ Đức Hospital
state: Tan Binh
Study officials:
affiliation: Mỹ Đức Hospital
name: Lan N Vuong, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: