Health Status of Children Born After Assisted Reproductive Technologies

Study Overview
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Brief Summary
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The goal of this observational study is to study the features of psychophysical development and the morbidity patterns of children born after assisted pregnancy, and to identify the connection with the health status of mothers, followed by the development of a prediction model and general principles of management of children born after ART. The main questions it aims to answer are: • the influence of premorbid background of mothers on children's physical development, disease occurrence and morbidity patterns of children born as after ART. To identify the indicators of cellular and humoral immunity in children born after different oocyte fertilization methods in IVF programs (classical IVF or ICSI). To study the long-term effects of ART on the endocrine status of children. It will be studied hemogram examination, immunity indicators (cellular components CD3, CD4, CD8, CD16, CD20, CD25, CD95, CD3 HLA DR+, CD# HLA-DR; humoral components - IgM, IgA, IgE, IgG) and laboratory investigations in endocrine system (TSH, free T3 and T4 levels, insulin, insulin-like growth factor-1 (IGF-1), somatotropic hormone (STH); glucose, potassium, sodium) in 120 children born after ART. Researchers will compare 132 children conceived spontaneously to see if ART can influent on the health status in future.

Detailed Description
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The tasks of the planned scientific and engineering project are based on the study of health status of children born after ART. The presence of a large cohort of children after ART in Kazakhstan will allow us to study morbidity patterns with the connection of mother's anamnesis, as well as to develop a prediction model and algorithms for the management of children conceived by assisted pregnancy. A comprehensive assessment of the health status of children born after ART will make it possible to determine the effect of the method of conception on the risks of immunity-related diseases and endocrine system pathology. It will allow us to predict deviations and ensure timely access to specialists and further examination. The presence of a burdened psychological background in couples with infertility may further influence the psychosocial adaptation of children conceived by ART and/or provoke higher morbidity rates in this group of children. It is important for the healthy and full integration of these children into society, including successful professional development in the future. 2.2. The project objective: to study the features of psychophysical development and the morbidity patterns of children born after assisted pregnancy, and to identify the connection with the health status of mothers, followed by the development of a prediction model and general principles of management of children born after ART. Project Tasks To study the influence of premorbid background of mothers on children's physical development, disease occurrence and morbidity patterns of children based on a retrospective study of 120 medical records of mothers and their children born as after ART. To determine the indicators of cellular and humoral immunity (hemogram examination, cellular components CD3, CD4, CD8, CD16, CD20, CD25, CD95, CD3 HLA DR+, CD# HLA-DR; humoral components - IgM, IgA, IgE, IgG) in children born after ART. To study the long-term effects of the hormone therapy in 120 mothers on the endocrine status (TSH, free T3 and T4 levels, insulin, insulin-like growth factor-1 (IGF-1), somatotropic hormone (STH); glucose, potassium, sodium) of children born after ART. To develop a prediction model and algorithms for the management of children born after ART.

Official Title
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Health Status of Children Born After Assisted Reproductive Technologies With the Development of Prediction Model and Principles of Child Management.

Conditions
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Children Born After Assisted Reproductive Technologies, Health Status, Child Development

Intervention / Treatment
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* Diagnostic Test: hemogram examination


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: successful ART program after IVF and ICSI, the transfer of fresh and frozen-thawed embryos (FET) a single or multiple pregnancy the birth of a child in the period from 2017 to 2023. Exclusion Criteria: intrauterine insemination ART programs with donor gametes surrogacy.

Ages Eligible for Study
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Minimum Age: 0 Months
Maximum Age: 60 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| children born after ART<br>120 children born after assisted reproductive technologies | Diagnostic Test: hemogram examination<br>* It will be studied hemogram examination, immunity indicators (cellular components CD3, CD4, CD8, CD16, CD20, CD25, CD95, CD3 HLA DR+, CD# HLA-DR; humoral components - IgM, IgA, IgE, IgG) and laboratory investigations in endocrine system (TSH, free T3 and T4 levels, insulin, insulin-like growth factor-1 (IGF-1), somatotropic hormone (STH); glucose, potassium, sodium) in 120 children born after ART. Researchers will compare 132 children conceived spontaneously to see if ART can influent on the health status in future.<br>* Other names: laboratory investigations in endocrine system (TSH, free T3 and T4 levels, insulin, insulin-like growth factor-1 (IGF-1), somatotropic hormone (STH); glucose, potassium, sodium);|
| children conceived spontaneously<br>132 children conceived spontaneously | Diagnostic Test: hemogram examination<br>* It will be studied hemogram examination, immunity indicators (cellular components CD3, CD4, CD8, CD16, CD20, CD25, CD95, CD3 HLA DR+, CD# HLA-DR; humoral components - IgM, IgA, IgE, IgG) and laboratory investigations in endocrine system (TSH, free T3 and T4 levels, insulin, insulin-like growth factor-1 (IGF-1), somatotropic hormone (STH); glucose, potassium, sodium) in 120 children born after ART. Researchers will compare 132 children conceived spontaneously to see if ART can influent on the health status in future.<br>* Other names: laboratory investigations in endocrine system (TSH, free T3 and T4 levels, insulin, insulin-like growth factor-1 (IGF-1), somatotropic hormone (STH); glucose, potassium, sodium);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Immune status of children born after assisted reproductive technologies | hemogram examination(leycosytes, lymphosytes), immunity indicators (cellular components CD3, CD4, CD8, CD16, CD20, CD25, CD95, CD3 HLA DR+, CD# HLA-DR; humoral components - IgM, IgA, IgE, IgG) | 1 day over which each participant is assessed | 
| laboratory investigations in endocrine system | TSH, free T3 and T4 levels, insulin, insulin-like growth factor-1 (IGF-1), somatotropic hormone (STH); glucose, potassium, sodium | 1 day over which each participant is assessed | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anthropometric measures | assessment of Weight-for-age (kg), Weight-for-length/height | 1 day over which each participant is assessed | 
| Anthropometric measures | assessment of Length/height-for-age (cm) | 1 day over which each participant is assessed | 
| Anthropometric measures | assessment of Head circumference for age (cm) | 1 day over which each participant is assessed | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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children born after assisted reproductive technologies, health status, in vitro fertilization, assisted reproductive technologies, infertility, children's health, morbidity patterns, endocrine status, immunological status, congenital malformations, maternal age, physical development