InfertilityFM-BABIES-5YNCT06369415
Health of Babies Born From IVF Versus IVM at 5 Years Old
An observational study of Infertility and IVF, run by Mỹ Đức Hospital at 1 site in Vietnam.
Trial 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… Read more about this study
- Who is it for?
- Ages 5 to 5 years
- Conditions the study is for
- Infertility, IVF, IVM
- What is being tested?
- Developmental score according to The Ages & Stages Questionnaires®, Third Edition - ASQ®-3 and behavioural screening according to Strength and Difficulties Questionnaires (SDQ's)
- How many people
- 214 participants
- Where
- 1 siteVietnam
- Study dates
- 16 Apr 2024to 30 Aug 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 5 years
- All sexes
- No healthy volunteers
- Child
Study population: Children participated in our previous follow-up study (NCT04296357)
Who may be able to join
- 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.
Who cannot join
- Babies died under or at 60 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Long-term Developmental and Behavioral Outcomes of Children Born From CAPA-IVM Versus Conventional IVF at 5-year-old
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.
Read the 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
- Being tested
- Developmental score according to The Ages & Stages Questionnaires®, Third Edition - ASQ®-3 and behavioural screening according to Strength and Difficulties Questionnaires (SDQ's)
- Keywords
- IVF, IVM, ASQ-3, childhood development
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| IVM children | Children born from in-vitro maturation. Receives: 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. Receives: Other: Developmental score according to The Ages & Stages Questionnaires®, Third Edition - ASQ®-3 and behavioural screening according to Strength and Difficulties Questionnaires (SDQ's) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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:
- emotional symptoms: from 5 to 10
- conduct problems: from 4 to 10
- hyperactivity/inattention: from 7 to 10
- peer relationship problems: from 4 to 10
- prosocial behaviour: from 0 to 4
- The total difficulties score: from 17 to 40
Measured: 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.
Measured: Up to 5 years after birth
Secondary outcomes (14)
Thinness rate
Thinness is a BMI less than -2 standard deviations below the WHO growth reference median.
Measured: Up to 5 years after birth
Overweight rate
Overweight is a BMI greater than 1 standard deviations above the WHO growth reference median.
Measured: Up to 5 years after birth
Obesity rate
Obesity is a weight greater than 2 standard deviations above the WHO growth reference median.
Measured: Up to 5 years after birth
Score of Communication (ASQ-3 questionnaire)
6 questions, if the answer is Yes, score = 10, Sometimes = 5 and Not yet = 0. Total score will be used: minimum = 0 and maximum = 60. Each aspect in each stage has an alternative threshold.
Measured: Up to 5 years after birth
Score of Gross motor (ASQ-3 questionnaire)
6 questions, if the answer is Yes, score = 10, Sometimes = 5 and Not yet = 0. Total score will be used: minimum = 0 and maximum = 60. Each aspect in each stage has an alternative threshold.
Measured: Up to 5 years after birth
Score of Fine motor (ASQ-3 questionnaire)
6 questions, if the answer is Yes, score = 10, Sometimes = 5 and Not yet = 0. Total score will be used: minimum = 0 and maximum = 60. Each aspect in each stage has an alternative threshold.
Measured: Up to 5 years after birth
Score of Problem solving (ASQ-3 questionnaire)
6 questions, if the answer is Yes, score = 10, Sometimes = 5 and Not yet = 0. Total score will be used: minimum = 0 and maximum = 60. Each aspect in each stage has an alternative threshold.
Measured: Up to 5 years after birth
Score of Personal-Social (ASQ-3 questionnaire)
6 questions, if the answer is Yes, score = 10, Sometimes = 5 and Not yet = 0. Total score will be used: minimum = 0 and maximum = 60. Each aspect in each stage has an alternative threshold.
Measured: Up to 5 years after birth
Score of Emotional symptoms (SDQ questionnaire)
5 questions, if the answer is Not True, score = 0, Somewhat True = 1 and Certianly True = 2.
Normal SDQ score is defined as the total score of each area out of the abnormal range for each one.
The abnormal range for Emotional symptoms is from 5 to 10.
Measured: Up to 5 years after birth
Score of Conduct problems (SDQ questionnaire)
5 questions, if the answer is Not True, score = 0, Somewhat True = 1 and Certianly True = 2.
This area has a question: "Generally well behaved, usually does what adults request." It needs to change the score to Not True, score = 2, Somewhat True = 1, and Certainly True = 0.
Normal SDQ score is defined as the total score of each area out of the abnormal range for each one.
Abnormal range for Conduct problems is from 4 to 10.
Measured: Up to 5 years after birth
Score of hyperactivity/inattention (SDQ questionnaire)
5 questions, if the answer is Not True, score = 0, Somewhat True = 1 and Certianly True = 2.
This area has two questions: "Thinks things out before acting" and "Good attention span, sees work through to the end." They need to change the score to Not True, score = 2, Somewhat True = 1, and Certainly True = 0.
Normal SDQ score is defined as the total score of each area out of the abnormal range for each one.
Abnormal range for hyperactivity/inattention is from 8 to 10.
Measured: Up to 5 years after birth
Score of peer relationship problems (SDQ questionnaire)
5 questions, if the answer is Not True, score = 0, Somewhat True = 1 and Certianly True = 2.
This area has two questions: "Has at least one good friend?" and "Generally liked by other children. "They need to change the scores to Not True, score = 2, Somewhat True, score = 1, and Certainly True, score = 0.
Normal SDQ score is defined as the total score of each area out of the abnormal range for each one.
Abnormal range for peer relationship problems is from 4 to 10.
Measured: Up to 5 years after birth
Score of prosocial behavior (SDQ questionnaire)
5 questions, if the answer is Not True, score = 0, Somewhat True = 1 and Certianly True = 2.
Normal SDQ score is defined as the total score of each area out of the abnormal range for each one.
Abnormal range for prosocial behavior is from 0 to 6.
Measured: Up to 5 years after birth
The total difficulties score.
The total difficulties score is generated by adding the score of emotional symptoms, conduct problems, hyperactivity/inattention and peer relationship problems together.
The abnormal range for the total difficulties score is from 17 to 40.
Measured: Up to 5 years after birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2024
- Study start16 Apr 2024
- Primary completion30 Aug 2025
- Study completion30 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfertilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 214 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mỹ Đức Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lan N Vuong, MD, PhD, Principal investigator, Mỹ Đức Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06369415
- Sponsor's protocol ID
- 04/24/DD-BVMD
- Acronym
- FM-BABIES-5Y
- Status last verified
- Sep 2025
- First submitted
- 11 Apr 2024
- Last updated
- 16 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Developmental and Behavioral Outcomes of Children Born From CAPA-IVM Versus Conventional IVF at 5-year-old
- ClinicalTrials.gov ID
- NCT06369415
- Acronym / sponsor ID
- FM-BABIES-5Y / 04/24/DD-BVMD
- Conditions
- Infertility, IVF, IVM, Development, Child
- Keywords
- IVF, IVM, ASQ-3, childhood development
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 214 participants (actual)
- Lead sponsor
- Mỹ Đức HospitalUniversity, hospital or other
- Study start
- 16 Apr 2024 (actual)
- Primary completion
- 30 Aug 2025 (actual)
- Study completion
- 30 Aug 2025 (actual)
- First posted
- 17 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IVM children | – | Other: Developmental score according to The Ages & Stages Questionnaires®, Third Edition - ASQ®-3 and behavioural screening according to Strength and Difficulties Questionnaires (SDQ's)Children born from in-vitro maturation. |
| IVF children | – | Other: Developmental score according to The Ages & Stages Questionnaires®, Third Edition - ASQ®-3 and behavioural screening according to Strength and Difficulties Questionnaires (SDQ's)Children born from conventiona in-vitro fertilization. |
Who may qualify
- Ages
- 5 to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children participated in our previous follow-up study (NCT04296357)
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- Babies died under or at 60 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Other | IVF children, IVM children |
Primary outcome
Normal ASQ-3 score rate.
Time frame: Up to 5 years after birth
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.
Normal SDQ score rate.
Time frame: Up to 5 years after birth
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
Normal weight rate
Time frame: Up to 5 years after birth
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.
14 secondary outcomes
Thinness rate
Time frame: Up to 5 years after birth
Overweight rate
Time frame: Up to 5 years after birth
Obesity rate
Time frame: Up to 5 years after birth
Score of Communication (ASQ-3 questionnaire)
Time frame: Up to 5 years after birth
Score of Gross motor (ASQ-3 questionnaire)
Time frame: Up to 5 years after birth
Score of Fine motor (ASQ-3 questionnaire)
Time frame: Up to 5 years after birth
Score of Problem solving (ASQ-3 questionnaire)
Time frame: Up to 5 years after birth
Score of Personal-Social (ASQ-3 questionnaire)
Time frame: Up to 5 years after birth
Score of Emotional symptoms (SDQ questionnaire)
Time frame: Up to 5 years after birth
Score of Conduct problems (SDQ questionnaire)
Time frame: Up to 5 years after birth
Score of hyperactivity/inattention (SDQ questionnaire)
Time frame: Up to 5 years after birth
Score of peer relationship problems (SDQ questionnaire)
Time frame: Up to 5 years after birth
Score of prosocial behavior (SDQ questionnaire)
Time frame: Up to 5 years after birth
The total difficulties score.
Time frame: Up to 5 years after birth
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lan N Vuong, MD, PhD principal investigator
Mỹ Đức Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infertility and IVF, run by Mỹ Đức Hospital at 1 site in Vietnam.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Vietnam. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Normal ASQ-3 score rate. (time frame: Up to 5 years after birth). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2025.