An observational study in IVM and IVF, sponsored by Mỹ Đức Hospital. Completed at 1 site in Vietnam. Open to participants aged 1 Month to 66 Months. Per ClinicalTrials.gov, last updated 2020-10-12.
Sponsored by Mỹ Đức Hospital · Observational
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.
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.
Mỹ Đức Hospital is the lead sponsor of 55 studies on the registry; 20 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Live babies born from CAPA-IVM, IVF or natural conception
Exclusion Criteria:
Live babies born from CAPA-IVM
Other: Developmental score according to The Ages & Stages Questionnaires®, Third Edition - ASQ®-3 · Other: Physical development and General Health · Other: Developmental Red flags
Live babies born from IVF/ICSI
Live babies born from natural conception
Other: Developmental score according to The Ages & Stages Questionnaires®, Third Edition - ASQ®-3 · Other: Physical development and General Health · Other: Developmental Red flags
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 examination
Developmental Red flags Questionnaires
The average total ASQ-3 score
* 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.
Time frame: Up to 66 months after birth
Score of Communication
* 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
Time frame: Up to 66 months after birth
Score of Gross motor
* 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
Time frame: Up to 66 months after birth
Score of Fine motor
* 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
Time frame: Up to 66 months after birth
Score of Problem solving
* 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
Time frame: Up to 66 months after birth
Score of Personal-Social
* 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
Time frame: Up to 66 months after birth
The presence of red flag signs by age
1. For children less than 4 months * Rolling prior to 3 months * Persistent fisting at 3 months * Failure to alert to environmental stimuli 2. For children from 4 to 6 months * Poor head control * Failure to reach for objects by 5 months * Absent smile 3. 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 4. 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)
Time frame: Up to 24 months after birth
Duration of breast-feeding
Duration of breast-feeding
Time frame: Up to 24 months after birth
Infant age at which weaning starts
Infant age at which weaning starts
Time frame: Up to 24 months after birth
Diseases that lead to hospital admission
Diseases that lead to hospital admission
Time frame: Up to 24 months after birth
Number of hospital admission
Number of hospital admission
Time frame: Up to 24 months after birth
Weight
Weight at 3, 6, 12, 18, 24 months and on the examination date
Time frame: At 3, 6, 12, 18, 24 months and on the examination date
Height
Height at 3, 6, 12, 18, 24 months and on the examination date
Time frame: At 3, 6, 12, 18, 24 months and on the examination date
Gestational age at delivery
Gestational age at delivery
Time frame: At birth
Mode of delivery
Vaginal birth or C-section
Time frame: At birth
Birth weight
Weight of baby born
Time frame: At birth
Length circumference
Length circumference after birth
Time frame: At birth
Head circumference
Head circumference after birth
Time frame: At birth
Rate of congenital anomalies
Any congenital anomalies detected in baby born
Time frame: At birth
5-min Apgar score
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).
Time frame: At 5 minute after birth
Rate of 5-min Apgar score <7
Rate of Apgar score at 5 minute after birth \<7
Time frame: At 5 minute after birth
Rate of Admission to neonatal intensive care unit
Admission to neonatal intensive care unit of baby
Time frame: Within 7 days after birth
Length of NICU admission
Number of admission days to NICU
Time frame: Up to 28 days after birth
Rate of Respiratory distress syndrome
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.
Time frame: Up to 28 days after birth
Rate of Periventricular haemorrhage
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.
Time frame: Up to 28 days after birth
Rate of Necrotizing enterocolitis
Necrotizing enterocolitis (NEC) will be diagnosed according to Bell.
Time frame: Up to 28 days after birth
Rate of Proven sepsis
Proven sepsis, will be diagnosed on the combination of clinical signs and positive blood cultures.
Time frame: Up to 28 days after birth
Rate of Composite of poor perinatal outcomes
Composite of poor perinatal outcomes, defined as intraventricular haemorrhage, respiratory distress syndrome, necrotizing enterocolitis or neonatal sepsis.
Time frame: Up to 28 days after birth
Plan to share: Undecided
This study is completed, as verified in Oct 2020. You cannot join it, but the record below documents what was studied.
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Mỹ Đức Hospital