Health of Babies Born From IVF Versus IVM at 5 Years Old (FM-BABIES-5Y)

Mỹ Đức Hospital

Status: Completed

Conditions: Development, Child; IVF; Infertility; IVM

Treatments: Other: Developmental score according to The Ages & Stages Questionnaires®, Third Edition - ASQ®-3 and behavioural screening according to Strength and Difficulties Questionnaires (SDQ's)

Study type: Observational

Funder types: Other

Identifiers

NCT06369415

04/24/DD-BVMD

Details and patient eligibility

About

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.

Full 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.

Enrollment: 214 patients

Sex: All

Ages: 5 to 5 years old

Volunteers: No Healthy Volunteers

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

Trial design

214 participants in 2 patient groups

IVM children

Description:

Children born from in-vitro maturation.

Treatment:

Other: Developmental score according to The Ages & Stages Questionnaires®, Third Edition - ASQ®-3 and behavioural screening according to Strength and Difficulties Questionnaires (SDQ's)

IVF children

Description:

Children born from conventiona in-vitro fertilization.

Treatment:

Other: Developmental score according to The Ages & Stages Questionnaires®, Third Edition - ASQ®-3 and behavioural screening according to Strength and Difficulties Questionnaires (SDQ's)