Health Status of Children Born After Assisted Reproductive Technologies

NCT06094998 | Completed

• 1 other identifier: ИРН AP14872103
• Study Type: observational
• Target: 252
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (1)

• Anthropometric measures

  1 day over which each participant is assessed

Study Arms (2)

children born after ART

120 children born after assisted reproductive technologies

Diagnostic Test: hemogram examination

children conceived spontaneously

132 children conceived spontaneously

Diagnostic Test: hemogram examination

Interventions

hemogram examination DIAGNOSTIC_TEST

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.

Also known as: 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 born after ART; children conceived spontaneously

Eligibility Criteria

• Age: 1 Month - 60 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• 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

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

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

Study Sites (1)

Scientific Center of Pediatrics and Pediatric Surgery

Almaty, 050044, Kazakhstan

Location

MeSH Terms

Conditions

Infertility; Congenital Abnormalities

Interventions

CD4 Lymphocyte Count

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Lymphocyte Count; Leukocyte Count; Blood Cell Count; Cell Count; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Hematologic Tests; Investigative Techniques; Cell Physiological Phenomena; Blood Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena

Study Officials

• Sevara K Ilmuratova

  Kazakhstan Medical University "KSPH"

  PRINCIPAL INVESTIGATOR

• Vyacheslav Lokshin, PhD

  International Clinical Centre of Reproduction "PERSONA"

  STUDY CHAIR

• Lyazzat Manzhuova, PhD

  Scientific Center of Pediatrics and Pediatric Surgery

  STUDY CHAIR

• Zhanar Nurgaliyeva, PhD

  Asfendiyarov Kazakh National Medical University

  PRINCIPAL INVESTIGATOR

• Farida Kussainova, MD

  Asfendiyarov Kazakh National Medical University

  PRINCIPAL INVESTIGATOR

• Аygul Bazarbaeva, MD

  Scientific Center of Pediatrics and Pediatric Surgery

  STUDY DIRECTOR

• Valeriya Nekhorosheva, MD

  Institute of Reproductive Medicine

  PRINCIPAL INVESTIGATOR

• Aygerim Abshekenova, MD

  International Clinical Centre of Reproduction "PERSONA"

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD candidate, Researcher

Study Record Dates

• First Submitted: October 17, 2023
• First Posted: October 23, 2023
• Study Start: October 18, 2023
• Primary Completion: January 19, 2024
• Study Completion: January 22, 2024
• Last Updated: March 7, 2024

Record last verified: 2024-03

Locations

KA (1)