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临床试验/NCT06094998
NCT06094998已完成不适用

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

Kazakhstan's Medical University "KSPH"1 个研究点 分布在 1 个国家目标入组 252 人开始时间: 2023年10月18日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
252
试验地点
1
主要终点
Immune status of children born after assisted reproductive technologies

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
1 Month 至 60 Months(Child)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • intrauterine insemination
  • ART programs with donor gametes
  • surrogacy.

结局指标

主要结局

Immune status of children born after assisted reproductive technologies

时间窗: 1 day over which each participant is assessed

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)

laboratory investigations in endocrine system

时间窗: 1 day over which each participant is assessed

TSH, free T3 and T4 levels, insulin, insulin-like growth factor-1 (IGF-1), somatotropic hormone (STH); glucose, potassium, sodium

次要结局

  • Anthropometric measures(1 day over which each participant is assessed)

研究者

发起方
Kazakhstan's Medical University "KSPH"
申办方类型
Other
责任方
Principal Investigator
主要研究者

Sevara Ilmuratova

PhD candidate, Researcher

Kazakhstan's Medical University "KSPH"

研究点 (1)

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