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

NCT06369415 | Completed

• 1 other identifier: 04/24/DD-BVMD
• Study Type: observational
• Target: 214
• Locations: 1 country
• Sites: 1

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.

Conditions

Infertility; IVF; IVM; Development, Child

Keywords

IVF; IVM; ASQ-3; childhood development

Outcome Measures

Primary Outcomes (3)

• Normal ASQ-3 score rate.

  A normal ASQ-3 score is the child's total score for each area above the cutoff. ASQ-3 (Ages and Stages Questionaires®) has 5 aspects: Communication, Gross motor, Fine motor, Problem solving, and Personal-Social Each aspect has 6 questions, if the answer is Yes, score = 10, Sometimes = 5 and Not yet = 0. ASQ-3 score = total area scores.

  Up to 5 years after birth

• Normal SDQ score rate.

  Normal SDQ score is defined as the total score of each area out of the abnormal range for each one. Abnormal range for each area is described as below: 1. emotional symptoms: from 5 to 10 2. conduct problems: from 4 to 10 3. hyperactivity/inattention: from 7 to 10 4. peer relationship problems: from 4 to 10 5. prosocial behaviour: from 0 to 4 6. The total difficulties score: from 17 to 40

  Up to 5 years after birth

• Normal weight rate

  Normal weight is a BMI greater than or equal to -2 standard deviations and less than or equal to 1 standard deviation of the WHO growth reference median.

  Up to 5 years after birth

Secondary Outcomes (14)

• Thinness rate

  Up to 5 years after birth

• Overweight rate

  Up to 5 years after birth

• Obesity rate

  Up to 5 years after birth

• Score of Communication (ASQ-3 questionnaire)

  Up to 5 years after birth

• Score of Gross motor (ASQ-3 questionnaire)

  Up to 5 years after birth

Study Arms (2)

IVM children

Children born from in-vitro maturation.

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

Children born from conventiona in-vitro fertilization.

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

Interventions

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

Eligibility Criteria

• Age: 5 Years - 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Children participated in our previous follow-up study (NCT04296357)

You may qualify if:

• 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.

You may not qualify if:

• Babies died under or at 60 months

Sponsors & Collaborators

• Mỹ Đức Hospital: lead

Study Sites (1)

Mỹ Đức Hospital

Ho Chi Minh City, Tan Binh, Vietnam

Location

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Study Officials

• Lan N Vuong, MD, PhD

  Mỹ Đức Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 11, 2024
• First Posted: April 17, 2024
• Study Start: April 16, 2024
• Primary Completion: August 30, 2025
• Study Completion: August 30, 2025
• Last Updated: September 16, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

VN (1)