An observational study in Infertility and IVF, sponsored by Mỹ Đức Hospital. Completed at 1 site in Vietnam. Open to participants aged 1 Month to 66 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-03-03.
Sponsored by Mỹ Đức Hospital · Observational
In order to give strong recommendation on the efficacy and safety of fresh versus frozen embryo transfer, we conduct this study in order to investigate the physical and mental development of children from fresh versus frozen embryo transfer. Based on our Freeze-only study (Vuong et al., 2018), the women without polycystic ovary syndrome undergoing the first or second IVF were randomly assigned to receive either fresh or frozen embryos on day 3 after oocyte retrieval, which leads to the similarity in characteristics of these two groups. Hence, the result from analysing these offsprings would be preciously valuable.
Since the first live birth after the transfer of a frozen-thawed embryo reported in 1984, cryopreservation has been considered as an enormous revolution in assisted reproductive technology (ART). It is observed that the trend of ART cycles using frozen embryo transfer is on the increase, which leads to a great deal number of children born from frozen embryos. This is the commencement of 2 embryo transfer strategies, the first one is transferring the fresh embryos, the other is freezing all the embryos and transfer them in the next cycle.
Comparing these two strategies, up till now, there are 4 published randomized control trials (RCTs) indicating different methods for certain groups of patients (Chen et al., 2016; Shi et al., 2018; Vuong et al., 2018; Wei et al., 2019). Regarding the efficacy, the freeze-all strategy outweighs the fresh embryo transfer in women with polycystic ovary syndrome (PCOS). While that efficacy gets a controversy in non-PCOS or ovulatory patients; two groups of authors indicated that these 2 strategies are equally effective, while the other group claims that the better result goes to cycles with frozen embryos. In term of safety, the rate of ovarian hyperstimulation syndrome (OHSS) is the equivalent or lower in the freeze-all group, which implies the important role of embryo-freezing in avoiding maternal risk. The question that whether freezing the embryos exerts effect on offspring is not thoroughly understood. The mostly used parameter in evaluating the safety of children is the perinatal status of infants, not the development of these children.
Searching literature, in 2010, S. Pelkonen published a large cohort study indicating that freezing the embryos do not change the rate of prematurity, low birthweight and being small for gestational age (Pelkonen et al., 2010). Looking further in our freeze-only study, our sub-analysis indicates that the livebirth weight of infants born from frozen embryos is 300 gram heavier than that from fresh embryos (Vuong et al., 2018). Following 4 studies comparing fresh and frozen embryo transfer, children from frozen embryos are similar or higher in term of newborn weight, and there is no study investigate the onward development of childrens born from these two strategies. The only proof on the development of children born from fresh verus frozen embryo is from one study with no randomization which states that children from fresh and frozen embryos share similar academic performance at the age 15-16 (Spangmose et al., 2019). We found no study investigate the impact of different embryo transfer strategies on the growth of children resulting from either fresh or frozen embryos.
In order to give strong recommendation on the efficacy and safety of fresh versus frozen embryo transfer, we conduct this study in order to investigate the physical and mental development of children from fresh versus frozen embryo transfer. Based on our Freeze-only study (Vuong et al., 2018), the women without polycystic ovary syndrome undergoing the first or second IVF were randomly assigned to receive either fresh or frozen embryos on day 3 after oocyte retrieval, which leads to the similarity in characteristics of these two groups. Hence, the result from analysing these offsprings would be preciously valuable.
2,506 studies on the registry are indexed under Infertility; 407 are open to participants now.
This study's enrollment of 255 is above the median of 200 across 714 observational studies indexed under Infertility.
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Live babies born following the frozen embryo transfer and fresh embryo transfer from our Freeze-only study (NCT02471573)
Exclusion Criteria:
Children born from freeze-only group and frozen embryo transfer
Other: Developmental score according to The Ages & Stages Questionnaires®, Third Edition - ASQ®-3 · Other: Physical development and General Health · Other: Developmental Red flags
Children born from fresh embryo transfer
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 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 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.
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.
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.
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.
Time frame: Up to 66 months after birth
The rate of children who have at least one red flag sign
He or she has at least one red flag sign by age From 2 to \< 3 year-old: * Has very unclear speech * Doesn't understand simple instruction • Doesn't speak in sentences * Doesn't make eye contact * Loses skills he/she once had From 3 to \< 4 year-old: * Can't jump in place * Doesn't play pretend or make-believe • Speaks unclearly * Can't retell a favorite story * Doesn't use "me" and "you" correctly * Loses skills he/she once had From 4 to \< 5.5 year-old: * Is easily distracted, has trouble focusing on one activity for more than 5 minutes • Doesn't talk about daily activities or experiences * Shows extreme behavior * Loses skills he/she once had
Time frame: From 2 to 5.5 years 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
Name of diseases that lead to hospital admission
Name of diseases that lead to hospital admission
Time frame: Up to 66 months after birth
Number of hospital admission
Number of hospital admission
Time frame: Up to 66 months after birth
Weight
Weight on the examination date
Time frame: Through study completion, an average of 1.5 months
Height
Height on the examination date
Time frame: Through study completion, an average of 1.5 months
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
Head circumference after birth Head circumference after birth Head circumference after birth 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
Length of neonatal intensive care unit (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
The rate of long-term illness and chronic conditions
Any long-term illness and chronic condition appears in a child
Time frame: Up to 66 months after birth
Plan to share: Undecided
This study is completed, as verified in Nov 2019. You cannot join it, but the record below documents what was studied.
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Mỹ Đức Hospital