Clinical trial NCT06094998: Health Status of Children Born After Assisted Reproductive Technologies
Official title: Health Status of Children Born After Assisted Reproductive Technologies With the Development of Prediction Model and Principles of Child Management.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Children Born After Assisted Reproductive Technologies
Health Status
Child Development
Keywords: 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
Lead sponsor: Kazakhstan's Medical University "KSPH"
Sponsor class: OTHER
Collaborators: name: Vyacheslav Notanovich Lokshin
name: Nurgalieva Zhanar Zhenisovna
name: Manzhuova Lyazzat Nurbapayevna
name: Abshekenova Aigerim Temirkhanovna
name: Valeria Nekhorosheva
name: Kusainova Farida Azimovna
First posted: 2023-10-23
Enrollment: 252
Sex: ALL
Minimum age (years): 1
Maximum age (years): 60
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: To determine the characteristics of the health status of children born after assisted reproductive technologies, a study was conducted on the basis of the Scientific Center of Pediatrics and Pediatric Surgery, the PERSONA International Clinical Center for Reproductology and the Institute of Reproductive Medicine in Almaty

Brief summary: 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: 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

1. 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.
2. 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.
3. 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.
4. To develop a prediction model and algorithms for the management of children born after ART.

Eligibility criteria: 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.

Primary outcomes:
measure: Immune status of children born after assisted reproductive technologies
timeFrame: 1 day over which each participant is assessed
measure: laboratory investigations in endocrine system
timeFrame: 1 day over which each participant is assessed
Secondary outcomes:
measure: Anthropometric measures
timeFrame: 1 day over which each participant is assessed
Other outcomes:
Locations:
city: Almaty
country: Kazakhstan
facility: Scientific Center of Pediatrics and Pediatric Surgery
Study officials:
affiliation: Kazakhstan Medical University "KSPH"
name: Sevara K Ilmuratova
role: PRINCIPAL_INVESTIGATOR
affiliation: International Clinical Centre of Reproduction "PERSONA"
name: Vyacheslav Lokshin, PhD
role: STUDY_CHAIR
affiliation: Scientific Center of Pediatrics and Pediatric Surgery
name: Lyazzat Manzhuova, PhD
role: STUDY_CHAIR
affiliation: Asfendiyarov Kazakh National Medical University
name: Zhanar Nurgaliyeva, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Asfendiyarov Kazakh National Medical University
name: Farida Kussainova, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Scientific Center of Pediatrics and Pediatric Surgery
name: Аygul Bazarbaeva, MD
role: STUDY_DIRECTOR
affiliation: Institute of Reproductive Medicine
name: Valeriya Nekhorosheva, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: International Clinical Centre of Reproduction "PERSONA"
name: Aygerim Abshekenova, MD
role: PRINCIPAL_INVESTIGATOR
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