Health of Children Born From ICSI With AOA (AOA-BABIES)
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
|
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| ICSI + AOA Children born after ICSI + AOA |
|
| Control Children born after ICSI |
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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 Outcome Measures
- 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.
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Mỹ Đức Hospital | Ho Chi Minh City | Vietnam | 70000 |
Sponsors and Collaborators
- Mỹ Đức Hospital
Investigators
- Principal Investigator: Lan Vuong Ngoc, PhD, Mỹ Đức Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 10/22/DD-BVMD