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.
