To compare the physical, mental and motor development of babies born from pregnancy using ICSI technique and and conventional IVF in non-male factor infertile couples. Based on our previous RCT (NCT03428919), the non-male factor couples were randomly assigned to IVF or ICSI, which leads to the similarity in characteristics of these two groups. Hence, the result of analyzing these offsprings would be preciously valuable.
Over the past two decades, intracytoplasmic sperm injection (ICSI) indications have been extended and routinely applied to all cases of assisted reproductive techniques: unexplained infertility, poor-quality oocytes, low oocyte yeild, advanced marternal age, prior failed fertilization with conventional insemination, after in-vitro maturation of oocytes and for cases of cryopreserved oocytes (Practice Committees of the American Society for Reproductive Medicine, 2020). In 2004, fertilization using ICSI accounted for nearly 60% of all aspirations globally. In the Middle East, the number of ICSI cycles increased rapidly from 2000 (47.6%) to 2007 (65.2%), and reached 97.8% in the Middle East in 2007 (Ishihara et al, 2015). Another survey recorded in Europe in 2011, out of a total of 437,510 cycles of fresh embryo transfer, 68% of cycles were performed using ICSI techniques. In male infertility cases, the rate of implementation of ICSI increased from 76.3% to 93.3%. In particular, in cases of non-male-factor infertility, the incidence of ICSI also increased from 15.4% to 66.9%. From 2008-2012, of 494 907 treatment cycles, 74.6% used ICSI. In which, ICSI accounts for 92.9% of the cycle of male infertility and 64.5% of the cycle of non-male-factor infertility (Boulet, 2015). However, ICSI is an invasive technique that bypasses the natural barriers of fertilization. This has led to concern about an increase in the incidence of anomalies in ICSI-born babies as this technique is increasingly being used in all cases of contraception. In contrast, there are studies that have also compared IVF with ICSI and show that in the ICSI cycle, the incidence of multiple pregnancies and low birth weight infants is lower than that of IVF, although there is no difference in infant survival between the two groups (Boulet et al, 2015). In addition to the short-term outcomes, the investigators also have to consider the long-term maternal and neonatal outcomes. There is still not much evidence comparing the effects of the above methods, if any, on the psychomotor development in children. Therefore, the investigators decide to conduct a study to compare the physical, mental and motor development of babies born from pregnancy using ICSI technique and and conventional IVF in non-male factor infertile couples.
Study Type
OBSERVATIONAL
Enrollment
322
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
Mỹ Đức Hospital
Ho Chi Minh City, Tan Binh, Vietnam
The number of patients having abnormal ASQ-3 scores in each aspect
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. Abnormal ASQ-3 score in an aspect = ASQ-3 score of 2 standard deviations below the mean of the aspect.
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
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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 12 to \< 18 month-old: * Doesn't crawl * Can't stand when supported * Doesn't search for things that he/she sees the participants hide * Doesn't say single words ("baba", "mama"...) * Doesn't learn gestures like waving or shaking head * Doesn't point to things * Loses skills he/she once had From 18 to \< 24 month-old: * Doesn't point to show things to others * Can't walk * Doesn't know what familiar things are for * Doesn't gain new words * Doesn't have at least 6 words * Doesn't notice or mind when a caregiver leaves or returns * Lose skills he once had From 24 to \< 36 month-old: * Doesn't use 2-word phrases * Doesn't know what to do with common things, like a brush, spoon * Doesn't copy actions and words * Doesn't follow simple instructions * Doesn't walk steadily * 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
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