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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06094998
Other study ID # ??? AP14872103
Secondary ID
Status Completed
Phase
First received
Last updated
Start date October 18, 2023
Est. completion date January 22, 2024

Study information

Verified date March 2024
Source Kazakhstan's Medical University "KSPH"
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 252
Est. completion date January 22, 2024
Est. primary completion date January 19, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 1 Month to 60 Months
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
hemogram examination
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.

Locations

Country Name City State
Kazakhstan Scientific Center of Pediatrics and Pediatric Surgery Almaty

Sponsors (7)

Lead Sponsor Collaborator
Kazakhstan's Medical University "KSPH" Abshekenova Aigerim Temirkhanovna, Kusainova Farida Azimovna, Manzhuova Lyazzat Nurbapayevna, Nurgalieva Zhanar Zhenisovna, Valeria Nekhorosheva, Vyacheslav Notanovich Lokshin

Country where clinical trial is conducted

Kazakhstan, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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 Anthropometric measures assessment of Weight-for-age (kg), Weight-for-length/height, assessment of Length/height-for-age (cm), assessment of Head circumference for age (cm) 1 day over which each participant is assessed
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