Health of Babies Born From IVF Versus IVM at 5 Years Old

NCT ID: NCT06369415

Last Updated: 2025-09-16

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 214 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-04-16
• Study Completion Date: 2025-08-30

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.

Conditions

Infertility; IVF; IVM; Development, Child

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

IVM children

Children born from in-vitro maturation.

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

Intervention Type: OTHER

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. The ASQ-3 covers five developmental domains: communication, gross motor, fine motor, problem-solving and personal-social behaviour.

The Strengths and Difficulties Questionnaire (SDQ) is a brief behavioural screening questionnaire for 2-17-year-olds. It exists in several versions to meet the needs of researchers, clinicians and educationalists. The SDQ asks about 25 attributes, some positive and others negative. These 25 items are divided between 5 scales: emotional symptoms, conduct problems; hyperactivity/inattention, peer relationship problems, and prosocial behaviour

IVF children

Children born from conventiona in-vitro fertilization.

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

Intervention Type: OTHER

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. The ASQ-3 covers five developmental domains: communication, gross motor, fine motor, problem-solving and personal-social behaviour.

The Strengths and Difficulties Questionnaire (SDQ) is a brief behavioural screening questionnaire for 2-17-year-olds. It exists in several versions to meet the needs of researchers, clinicians and educationalists. The SDQ asks about 25 attributes, some positive and others negative. These 25 items are divided between 5 scales: emotional symptoms, conduct problems; hyperactivity/inattention, peer relationship problems, and prosocial behaviour

Interventions

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

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. The ASQ-3 covers five developmental domains: communication, gross motor, fine motor, problem-solving and personal-social behaviour.

The Strengths and Difficulties Questionnaire (SDQ) is a brief behavioural screening questionnaire for 2-17-year-olds. It exists in several versions to meet the needs of researchers, clinicians and educationalists. The SDQ asks about 25 attributes, some positive and others negative. These 25 items are divided between 5 scales: emotional symptoms, conduct problems; hyperactivity/inattention, peer relationship problems, and prosocial behaviour

Intervention Type: OTHER

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

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 5 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mỹ Đức Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lan N Vuong, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Mỹ Đức Hospital

Locations

Mỹ Đức Hospital

Ho Chi Minh City, Tan Binh, Vietnam

Countries

Vietnam

Other Identifiers

04/24/DD-BVMD

Identifier Type: -

Identifier Source: org_study_id