Health of Children Born From ICSI With AOA (AOA-BABIES)
- Conditions
- Intracytoplasmic Sperm InjectionInfertility
- Registration Number
- NCT05578118
- Lead Sponsor
- Mỹ Đức Hospital
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 63
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)
Embryos with PGT. Oocyte donation
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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.
Number of hospital admission 12 months after birth Number of hospital admission
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.
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 pointsDuration of breastfeeding 12 months after birth Duration of breastfeeding
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.
Name of diseases that lead to hospital admission 12 months after birth Name of diseases that lead to hospital admission
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.
Weight 12 months after birth Weight on the examination date
Infant age at which weaning starts 12 months after birth Infant age at which weaning starts
Height 12 months after birth Height on the examination date
Trial Locations
- Locations (1)
Mỹ Đức Hospital
🇻🇳Ho Chi Minh City, Vietnam