Infertility Clinical Trial
Official title:
Physical, Mental, and Motor Development of Children Born From Intracytoplasmic Sperm Injection With Assisted Oocyte Activation With Calcium Ionophore
Verified date | August 2023 |
Source | M? Ð?c Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 63 |
Est. completion date | March 30, 2023 |
Est. primary completion date | March 30, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 12 Months to 12 Months |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Vietnam | M? Ð?c Hospital | Ho Chi Minh City |
Lead Sponsor | Collaborator |
---|---|
M? Ð?c Hospital |
Vietnam,
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* Note: There are 23 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Gestational age at delivery | Gestational age at delivery | At birth | |
Other | Mode of delivery | Vaginal birth or C-section | At birth | |
Other | Birth weight | Weight of baby born | At birth | |
Other | Length circumference | Length circumference after birth | At birth | |
Other | Head circumference | Head circumference after birth | At birth | |
Other | Rate of congenital anomalies | Any congenital anomalies detected in baby born | At birth | |
Other | Length of neonatal intensive care unit (NICU) admission | Number of admission days to NICU | Up to 28 days after birth | |
Other | 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 | Up to 28 days after birth | |
Other | 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. | Up to 28 days after birth | |
Other | Rate of Necrotizing enterocolitis | Necrotizing enterocolitis (NEC) will be diagnosed according to Bell. | Up to 28 days after birth | |
Other | Rate of Proven sepsis | Proven sepsis, will be diagnosed on the combination of clinical signs and positive blood cultures. | Up to 28 days after birth | |
Other | Rate of Composite of poor perinatal outcomes | Composite of poor perinatal outcomes, defined as intraventricular haemorrhage, respiratory distress syndrome, necrotizing enterocolitis or neonatal sepsis. | Up to 28 days after birth | |
Other | Rate of long-term illness and chronic conditions | Any long-term illness and chronic condition appears in a child. | Up to 28 days after birth | |
Primary | The percentage of abnormal ASQ-3 score | 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. |
12 months after birth | |
Secondary | 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 aspect in each stage has an alternative threshold. | 12 months after birth | |
Secondary | 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 aspect in each stage has an alternative threshold. | 12 months after birth | |
Secondary | 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 aspect in each stage has an alternative threshold. | 12 months after birth | |
Secondary | Score of Problem-solving skill | 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. | 12 months after birth | |
Secondary | 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 aspect in each stage has an alternative threshold. | 12 months after birth | |
Secondary | The rate of children who have at least one red flag sign(s): | 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 |
12 months after birth | |
Secondary | Duration of breastfeeding | Duration of breastfeeding | 12 months after birth | |
Secondary | Infant age at which weaning starts | Infant age at which weaning starts | 12 months after birth | |
Secondary | Name of diseases that lead to hospital admission | Name of diseases that lead to hospital admission | 12 months after birth | |
Secondary | Number of hospital admission | Number of hospital admission | 12 months after birth | |
Secondary | Weight | Weight on the examination date | 12 months after birth | |
Secondary | Height | Height on the examination date | 12 months after birth |
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