Skip to main content
OpenTrials
Completed

NCT Number: NCT04048486

Children Born From IVM-CAPA vs IVF or Natural Conception

CAPA-IVM is a new promising IVM technique involving the use of a new compound to facilitate the oocyte and embryo competence. CAPA-IVM preserved the maintenance of trans-zonal projections and significantly improved maturation rate and blastocyst yield. NGS analysis of 20 good quality CAPA-IVM blastocysts did not reveal increased aneuploidy compared to age-matched routine ICSI patients. The first CAPA-IVM baby was born in 2017 at My Duc Hospital, Vietnam and up to now, there are 33 babies born from this technique. There is no study to investigate the development of babies born from CAPA-IVM.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Age range

1 month–66 month

Sex eligibility

All sexes

Study type

Observational

Primary location

Mỹ Đức Hospital

Ho Chi Minh City, Tan Binh, Vietnam

About this study

Assisted reproductive technologies (ART), such as in vitro fertilization (IVF), intracytoplasmic sperm injection (ICSI) and in vitro maturation (IVM), are widely used to solve human infertility, and have provided great benefits for millions of couples who have struggled with infertility disorders. The use of ART has been growing persistently and more than 8 million babies worldwide have been born via ART since the first IVF conceived child was born in 1978 (ESHRE monitoring).

During the last two decades, many studies have shown that children born following assisted reproductive techniques (ART) have an increased risk of adverse obstetric, perinatal and short-term follow-up outcomes when compared to naturally conceived (NC) infants (Jackson RA 2004, Helmerhorst et al., 2004; Pinborg et al., 2013; Adams et al., 2015). The etiologies of this association are mainly related to higher proportion of multiple pregnancies due to double embryo transfer option and greater rate of unfavorable comorbidities of infertile women (older age, high BMI, diabetes…). But with the trend toward single embryo transfer in current IVF practice, there are existing evidences supporting that the perinatal risks of singleton gestations following IVF treatment are still higher than those that result from a spontaneous conception (McDonald et al., 2009; Pandey et al., 2012).

Long-term development of children born by ART is also a concerned issue. It is evident that children born as a result of IVF treatment have an excess rate of congenital abnormalities, higher risk of developing metabolic, cardiovascular disorders and subclinical hyperthyroidism in later life (Roger Hart and Robert J. Norman, 2013, part I). Regarding mental health and development outcomes, cerebral palsy and slight neurodevelopmental delay are potential long-term associations with ART (Roger Hart and Robert J. Norman, 2013, part II). However, these adverse outcomes can be explained by obstetric factors (higher rate of prematurity and intrauterine growth restriction) rather than IVF. This leads to the concern about research biases in studies of long-term development of children born by ART where multiple gestations, prematurity, neonatal hospitalization and growth restriction were not well-controlled. Another concern about long-term follow-up studies of IVF children is the limitation of literatures and high-quality clinical trials that investigate the general health outcomes of children born by ART. The majority of valuable data only exist on the short-term outcome of infants born as a result of IVF treatment (Kalra and Barnhart, 2011) even though it is possible that some suspected disorders might only be identifiable beyond the first year of life (Oliver et al., 2012).

When studying about the long-term development of children following ART, a very important factor need to be considered is the medium of culture. There have been existing theories that proposed the mechanism of how epigenetic environment can up or down-regulate a set of genes which then results in the changes in embryonic growth or even the long-term development of children in later stage of life. Different ART methods may cause possible changes in DNA methylation patterns which in turn affect development of the placenta and fetus. This is the "developmental origins of health and disease hypothesis" (DOHaD) explaning why exposure to an adverse environment (possibly the culture medium) may result in unfavorable development and illnesses profiles in the ART offspring (Barker, 2007).

CAPA-IVM is a new promising IVM technique involving the use of a new compound to facilitate the oocyte and embryo competence. CAPA-IVM preserved the maintenance of trans-zonal projections and significantly improved maturation rate and blastocyst yield. NGS analysis of 20 good quality CAPA-IVM blastocysts did not reveal increased aneuploidy compared to age matched routine ICSI patients. The first CAPA-IVM baby was born in 2017 at My Duc Hospital, Vietnam and up to now, there are 33 babies born from this technique. There is no study to investigate the development of babies born from CAPA-IVM.

The investigators therefore conduct this study to investigate the physical and mental development of babies born from CAPA-IVM, IVF or natural conception.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Live babies born from CAPA-IVM
  • Live babies born from IVF
  • Live babies born from natural conception
  • Parents agree to participate

Exclusion criteria

  • Babies born from oocyte donation cycles
  • Babies born from sperm donation cycles
  • Babies born from PGT cycles

Treatment and study plan

Developmental score according to The Ages & Stages Questionnaires®, Third Edition - ASQ®-3

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.

Physical development and General Health

Other

Physical development and General health examination

Developmental Red flags

Other

Developmental Red flags Questionnaires

Primary outcomes

  1. The average total ASQ-3 score

    Time frame: Up to 66 months after birth

    • ASQ-3 (Ages and Stages Questionares®) has 5 aspects: Communication, Gross motor, Fine motor, Problem solving and Personal-Social
    • Each aspesct has 6 questions, if the answer is Yes, score = 10, Sometimes = 5 and Not yet = 0.
    • ASQ-3 average = average score of 5 aspects.

Secondary outcomes

  1. Score of Communication

    Time frame: Up to 66 months after birth

    • 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 aspects in each stages has alternative threshold
  2. Score of Gross motor

    Time frame: Up to 66 months after birth

    • 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 aspects in each stages has alternative threshold
  3. Score of Fine motor

    Time frame: Up to 66 months after birth

    • 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 aspects in each stages has alternative threshold
  4. Score of Problem solving

    Time frame: Up to 66 months after birth

    • 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 aspects in each stages has alternative threshold
  5. Score of Personal-Social

    Time frame: Up to 66 months after birth

    • 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 aspects in each stages has alternative threshold
  6. The presence of red flag signs by age

    Time frame: Up to 24 months after birth

    • For children less than 4 months
    • Rolling prior to 3 months
    • Persistent fisting at 3 months
    • Failure to alert to environmental stimuli
    • For children from 4 to 6 months
    • Poor head control
    • Failure to reach for objects by 5 months
    • Absent smile
    • For children from 6 to 12 months
    • Absent babbling by 6 months
    • W-sitting at 7 months
    • Inability to localize sound by 10 months
    • Persistent mouthing of objects at 12 months
    • Lack of consonant production by 15 months
    • For children from 12 to 24 months
    • Lack of imitation by 16 months
    • Lack of protodeclarative pointing by 18 months
    • Hand dominance prior to 18 months
    • Inability to walk up and down stairs at 24 months
    • Advanced non-communicative speech (meaningless communication repertoires)
    • Delayed Language Development milestone (50 single words at 24 months)
  7. Duration of breast-feeding

    Time frame: Up to 24 months after birth

    Duration of breast-feeding

  8. Infant age at which weaning starts

    Time frame: Up to 24 months after birth

    Infant age at which weaning starts

  9. Diseases that lead to hospital admission

    Time frame: Up to 24 months after birth

    Diseases that lead to hospital admission

  10. Number of hospital admission

    Time frame: Up to 24 months after birth

    Number of hospital admission

  11. Weight

    Time frame: At 3, 6, 12, 18, 24 months and on the examination date

    Weight at 3, 6, 12, 18, 24 months and on the examination date

  12. Height

    Time frame: At 3, 6, 12, 18, 24 months and on the examination date

    Height at 3, 6, 12, 18, 24 months and on the examination date

Other outcomes

  1. Gestational age at delivery

    Time frame: At birth

    Gestational age at delivery

  2. Mode of delivery

    Time frame: At birth

    Vaginal birth or C-section

  3. Birth weight

    Time frame: At birth

    Weight of baby born

  4. Length circumference

    Time frame: At birth

    Length circumference after birth

  5. Head circumference

    Time frame: At birth

    Head circumference after birth

  6. Rate of congenital anomalies

    Time frame: At birth

    Any congenital anomalies detected in baby born

  7. 5-min Apgar score

    Time frame: At 5 minute after birth

    The Apgar score is determined by evaluating the newborn baby on five simple criteria on a scale from zero to two, then summing up the five values thus obtained. The resulting Apgar score ranges from zero to 10. The five criteria are summarized using words chosen to form a backronym (Appearance, Pulse, Grimace, Activity, Respiration).

  8. Rate of 5-min Apgar score <7

    Time frame: At 5 minute after birth

    Rate of Apgar score at 5 minute after birth <7

  9. Rate of Admission to neonatal intensive care unit

    Time frame: Within 7 days after birth

    Admission to neonatal intensive care unit of baby

  10. Length of NICU admission

    Time frame: Up to 28 days after birth

    Number of admission days to NICU

  11. Rate of Respiratory distress syndrome

    Time frame: Up to 28 days after birth

    Respiratory distress syndrome (RDS), diagnosed as the presence of tachypnoea >60/minute, sternal recession and expiratory grunting, need for supplemental oxygen, and a radiological picture of diffuse reticulogranular shadowing with an air bronchogram.

  12. Rate of Periventricular haemorrhage

    Time frame: Up to 28 days after birth

    Periventricular haemorrhage II B or worse, will be diagnosed by repeated neonatal cranial ultrasound by the neonatologist according to the guidelines on neuro-imaging described by de Vries et al.

  13. Rate of Necrotizing enterocolitis

    Time frame: Up to 28 days after birth

    Necrotizing enterocolitis (NEC) will be diagnosed according to Bell.

  14. Rate of Proven sepsis

    Time frame: Up to 28 days after birth

    Proven sepsis, will be diagnosed on the combination of clinical signs and positive blood cultures.

  15. Rate of Composite of poor perinatal outcomes

    Time frame: Up to 28 days after birth

    Composite of poor perinatal outcomes, defined as intraventricular haemorrhage, respiratory distress syndrome, necrotizing enterocolitis or neonatal sepsis.

Sponsors and collaborators

Lead sponsor

Mỹ Đức Hospital

Other

Registry information

Official study title

Follow-up of Children Born From CAPA-IVM IVF or Natural Conception: a Prospective Cohort Study

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Aug 7, 2019
Registry last updated
Oct 12, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.