Health Status of Children Born After Assisted Reproductive Technologies

Sponsor
Kazakhstan's Medical University "KSPH" (Other)
Overall Status
Recruiting
CT.gov ID
NCT06094998
Collaborator
Vyacheslav Notanovich Lokshin (Other), Nurgalieva Zhanar Zhenisovna (Other), Manzhuova Lyazzat Nurbapayevna (Other), Abshekenova Aigerim Temirkhanovna (Other), Valeria Nekhorosheva (Other), Kusainova Farida Azimovna (Other)
252
1
10
25.1

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: hemogram examination

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.

Study Design

Study Type:
Observational
Anticipated Enrollment :
252 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Health Status of Children Born After Assisted Reproductive Technologies With the Development of Prediction Model and Principles of Child Management.
Anticipated Study Start Date :
Oct 1, 2023
Anticipated Primary Completion Date :
Aug 1, 2024
Anticipated Study Completion Date :
Aug 1, 2024

Arms and Interventions

Arm Intervention/Treatment
children born after ART

120 children born after assisted reproductive technologies

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.
Other Names:
  • 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 (TSH, free T3 and T4 levels, insulin, insulin-like growth factor-1 (IGF-1), somatotropic hormone (STH); glucose, potassium, sodium)
  • children conceived spontaneously

    132 children conceived spontaneously

    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.
    Other Names:
  • 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 (TSH, free T3 and T4 levels, insulin, insulin-like growth factor-1 (IGF-1), somatotropic hormone (STH); glucose, potassium, sodium)
  • Outcome Measures

    Primary Outcome Measures

    1. Immune status of children born after assisted reproductive technologies [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)

    2. laboratory investigations in endocrine system [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

    Secondary Outcome Measures

    1. Anthropometric measures [1 day over which each participant is assessed]

      assessment of anthropometric characteristics (Weight-for-age, Weight-for-length/height, Length/height-for-age, Head circumference for age)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    0 Months to 60 Months
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    successful ART program after IVF and ICSI, as well as the transfer of fresh and frozen-thawed embryos (FET) with the onset of a single or multiple pregnancy and the birth of a child in the period from 2017 to 2023.

    Exclusion Criteria:

    intrauterine insemination using the sperm of either a woman's partner or a sperm donor, as well as programs with donor gametes and surrogacy.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Sevara ilmuratova Almaty Kazakhstan 050057

    Sponsors and Collaborators

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

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Sevara Ilmuratova, PhD candidate, Researcher, Kazakhstan's Medical University "KSPH"
    ClinicalTrials.gov Identifier:
    NCT06094998
    Other Study ID Numbers:
    • ИРН AP14872103
    First Posted:
    Oct 23, 2023
    Last Update Posted:
    Oct 23, 2023
    Last Verified:
    Oct 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Sevara Ilmuratova, PhD candidate, Researcher, Kazakhstan's Medical University "KSPH"
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Oct 23, 2023