Infertility, Intracytoplasmic Sperm Injection
Conditions
Keywords
ICSI, Total fertilization failure, AOA, ASQ-3, Health of children
Brief summary
The investigators follow up on the development of children born from ICSI-AOA using the Developmental Red Flags and Ages & Stages Third Edition (ASQ-3) Questionnaires to give strong evidence about the safety of AOA in assisted reproductive technology.
Detailed description
Intracytoplasmic sperm injection (ICSI) is the most widely utilized assisted reproductive technique (ART) worldwide. Fertilization rates obtained after ICSI treatment are reported between 70 and 80%, representing the most efficient ART; however, complete post-ICSI fertilization failure still occurs in 3-5% of cases. The leading cause of failed fertilization is failure to achieve oocyte activation, a crucial stage in the initiation of embryo development during fertilization. Assisted oocyte activation (AOA) using a calcium ionophore has been used for over a decade following ICSI fertilization failure. AOA is not considered a routine practice of ART yet, which is only suitable for patients with proper indications, including (i) total fertilization failure or low fertilization rate (\<30%) in the previous IVF; (ii) severe male factor infertility; (iii) patients with a history of embryo arrest or poor embryo quality in previous IVF cycle. Regarding technique, the artificial rise of induced calcium rises cannot precisely mimic the physiologically sperm-induced calcium oscillations. Little is known yet about the possible adverse effects of ionophores on post-implantation embryo development. Numerous studies have been conducted to compare the development of children born from ICSI - AOA versus non-AOA. Thus, the investigators performed this study to investigate the physical, mental, and motor development of children born following ICSI - AOA using the Developmental Red Flags and Ages & Stages Third Edition (ASQ-3) Questionnaires.
Interventions
None listed
Sponsors
Mỹ Đức Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
12 Months to 12 Months
Healthy volunteers
No
Inclusion criteria
All single, live babies born following ICSI with AOA and ICSI without AOA from 08/2020 to 04/2021. Parents consent to participate in the study. Group ICSI+AOA: Embryos from ICSI with AOA with calcium ionophore In the ICSI+AOA group, indications of AOA are: * Previous failed IVF treatment with no fertilization or poor fertilization rate (fertilized oocytes/pick-up oocytes\<35%) or poor embryo result (number of embryos/pick-up oocytes\<35%, \<3 embryos, no good-quality embryo) * Using sperm after retrieval technique, cryptozoospermia Group Control: Embryos from ICSI without AOA. In the Control group, the indications of AOA for the next IVF cycle (if patients continue the next IVF cycle) are: * Currently failed IVF treatment with no fertilization or poor fertilization rate (fertilized oocytes/pick-up oocytes\<35%) or poor embryo result (number of embryos/pick-up oocytes\<35%, \<3 embryos, no good-quality embryo)
Exclusion criteria
Embryos with PGT. Oocyte donation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The percentage of abnormal ASQ-3 score | 12 months after birth | ASQ-3 (Ages and Stages Questionaires®) has 5 aspects: Communication, Gross Motor, Fine Motor, Problem-solving, and Personal-Social Each element 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
| Measure | Time frame | Description |
|---|---|---|
| Score of Communication | 12 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 aspect in each stage has an alternative threshold. |
| Score of Gross motor | 12 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 aspect in each stage has an alternative threshold. |
| Score of Fine motor | 12 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 aspect in each stage has an alternative threshold. |
| Score of Problem-solving skill | 12 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 aspect in each stage has an alternative threshold. |
| Score of Personal-Social | 12 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 aspect in each stage has an alternative threshold. |
| The rate of children who have at least one red flag sign(s): | 12 months after birth | For children at 12 months: they * No response when being called by their name * Does not understand no * Can not stand even when being supported * Apathy or non-observance of the caregiver * Does not look at the point where the caregiver points |
| Duration of breastfeeding | 12 months after birth | Duration of breastfeeding |
| Infant age at which weaning starts | 12 months after birth | Infant age at which weaning starts |
| Name of diseases that lead to hospital admission | 12 months after birth | Name of diseases that lead to hospital admission |
| Number of hospital admission | 12 months after birth | Number of hospital admission |
| Weight | 12 months after birth | Weight on the examination date |
| Height | 12 months after birth | Height on the examination date |
Other
| Measure | Time frame | Description |
|---|---|---|
| Gestational age at delivery | At birth | Gestational age at delivery |
| Mode of delivery | At birth | Vaginal birth or C-section |
| Birth weight | At birth | Weight of baby born |
| Length circumference | At birth | Length circumference after birth |
| Head circumference | At birth | Head circumference after birth |
| Rate of congenital anomalies | At birth | Any congenital anomalies detected in baby born |
| Length of neonatal intensive care unit (NICU) admission | Up to 28 days after birth | Number of admission days to NICU |
| Rate of Respiratory distress syndrome | 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 |
| Rate of Periventricular haemorrhage | 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. |
| Rate of Necrotizing enterocolitis | Up to 28 days after birth | Necrotizing enterocolitis (NEC) will be diagnosed according to Bell. |
| Rate of Proven sepsis | Up to 28 days after birth | Proven sepsis, will be diagnosed on the combination of clinical signs and positive blood cultures. |
| Rate of Composite of poor perinatal outcomes | Up to 28 days after birth | Composite of poor perinatal outcomes, defined as intraventricular haemorrhage, respiratory distress syndrome, necrotizing enterocolitis or neonatal sepsis. |
| Rate of long-term illness and chronic conditions | Up to 28 days after birth | Any long-term illness and chronic condition appears in a child. |
Countries
Vietnam
Outcome results
None listed