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Completed

NCT Number: NCT05578118

Health of Children Born From ICSI With AOA (AOA-BABIES)

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.

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Key information

Conditions

Infertility Genital Diseases Intracytoplasmic Sperm Injection Urogenital Diseases

Age range

12 month–12 month

Sex eligibility

All sexes

Study type

Observational

Primary location

Mỹ Đức Hospital

Ho Chi Minh City, 70000, Vietnam

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. The percentage of abnormal ASQ-3 score

    Time frame: 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 outcomes

  1. Score of Communication

    Time frame: 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.

  2. Score of Gross motor

    Time frame: 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.

  3. Score of Fine motor

    Time frame: 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.

  4. Score of Problem-solving skill

    Time frame: 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.

  5. Score of Personal-Social

    Time frame: 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.

  6. The rate of children who have at least one red flag sign(s):

    Time frame: 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

  7. Duration of breastfeeding

    Time frame: 12 months after birth

    Duration of breastfeeding

  8. Infant age at which weaning starts

    Time frame: 12 months after birth

    Infant age at which weaning starts

  9. Name of diseases that lead to hospital admission

    Time frame: 12 months after birth

    Name of diseases that lead to hospital admission

  10. Number of hospital admission

    Time frame: 12 months after birth

    Number of hospital admission

  11. Weight

    Time frame: 12 months after birth

    Weight on the examination date

  12. Height

    Time frame: 12 months after birth

    Height on the examination date

Other outcomes

  1. Gestational age at delivery

    Time frame: At birth

    Gestational age at delivery

  2. Mode of delivery

    Time frame: At birth

    Vaginal birth or C-section

  3. Birth weight

    Time frame: At birth

    Weight of baby born

  4. Length circumference

    Time frame: At birth

    Length circumference after birth

  5. Head circumference

    Time frame: At birth

    Head circumference after birth

  6. Rate of congenital anomalies

    Time frame: At birth

    Any congenital anomalies detected in baby born

  7. Length of neonatal intensive care unit (NICU) admission

    Time frame: Up to 28 days after birth

    Number of admission days to NICU

  8. Rate of Respiratory distress syndrome

    Time frame: 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

  9. Rate of Periventricular haemorrhage

    Time frame: 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.

  10. Rate of Necrotizing enterocolitis

    Time frame: Up to 28 days after birth

    Necrotizing enterocolitis (NEC) will be diagnosed according to Bell.

  11. Rate of Proven sepsis

    Time frame: Up to 28 days after birth

    Proven sepsis, will be diagnosed on the combination of clinical signs and positive blood cultures.

  12. Rate of Composite of poor perinatal outcomes

    Time frame: Up to 28 days after birth

    Composite of poor perinatal outcomes, defined as intraventricular haemorrhage, respiratory distress syndrome, necrotizing enterocolitis or neonatal sepsis.

  13. Rate of long-term illness and chronic conditions

    Time frame: Up to 28 days after birth

    Any long-term illness and chronic condition appears in a child.

Sponsors and collaborators

Lead sponsor

Mỹ Đức Hospital

Other

Registry information

Official study title

Physical, Mental, and Motor Development of Children Born From Intracytoplasmic Sperm Injection With Assisted Oocyte Activation With Calcium Ionophore

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Oct 13, 2022
Registry last updated
Apr 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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