Clinical trial NCT05578118: Health of Children Born From ICSI With AOA (AOA-BABIES)
Official title: Physical, Mental, and Motor Development of Children Born From Intracytoplasmic Sperm Injection With Assisted Oocyte Activation With Calcium Ionophore
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Infertility
Intracytoplasmic Sperm Injection
Keywords: ICSI
Total fertilization failure
AOA
ASQ-3
Health of children
Lead sponsor: Mỹ Đức Hospital
Sponsor class: OTHER
First posted: 2022-10-13
Enrollment: 63
Sex: ALL
Minimum age (years): 12
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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

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)

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.

Eligibility 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

Primary outcomes:
measure: The percentage of abnormal ASQ-3 score
timeFrame: 12 months after birth
Secondary outcomes:
measure: Score of Communication
timeFrame: 12 months after birth
measure: Score of Gross motor
timeFrame: 12 months after birth
measure: Score of Fine motor
timeFrame: 12 months after birth
measure: Score of Problem-solving skill
timeFrame: 12 months after birth
measure: Score of Personal-Social
timeFrame: 12 months after birth
measure: The rate of children who have at least one red flag sign(s):
timeFrame: 12 months after birth
measure: Duration of breastfeeding
timeFrame: 12 months after birth
measure: Infant age at which weaning starts
timeFrame: 12 months after birth
measure: Name of diseases that lead to hospital admission
timeFrame: 12 months after birth
measure: Number of hospital admission
timeFrame: 12 months after birth
measure: Weight
timeFrame: 12 months after birth
measure: Height
timeFrame: 12 months after birth
Other outcomes:
measure: Gestational age at delivery
timeFrame: At birth
measure: Mode of delivery
timeFrame: At birth
measure: Birth weight
timeFrame: At birth
measure: Length circumference
timeFrame: At birth
measure: Head circumference
timeFrame: At birth
measure: Rate of congenital anomalies
timeFrame: At birth
measure: Length of neonatal intensive care unit (NICU) admission
timeFrame: Up to 28 days after birth
measure: Rate of Respiratory distress syndrome
timeFrame: Up to 28 days after birth
measure: Rate of Periventricular haemorrhage
timeFrame: Up to 28 days after birth
measure: Rate of Necrotizing enterocolitis
timeFrame: Up to 28 days after birth
measure: Rate of Proven sepsis
timeFrame: Up to 28 days after birth
measure: Rate of Composite of poor perinatal outcomes
timeFrame: Up to 28 days after birth
measure: Rate of long-term illness and chronic conditions
timeFrame: Up to 28 days after birth
Locations:
city: Ho Chi Minh City
country: Vietnam
facility: Mỹ Đức Hospital
Study officials:
affiliation: Mỹ Đức Hospital
name: Lan Vuong Ngoc, PhD
role: PRINCIPAL_INVESTIGATOR
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