Children Born After Assisted Reproductive TechnologiesNCT06094998
Health Status of Children Born After Assisted Reproductive Technologies
An observational study of Children Born After Assisted Reproductive Technologies and Health Status, run by Kazakhstan's Medical University "KSPH" at 1 site in Kazakhstan.
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… Read more about this study
- Who is it for?
- Ages 1 month to 60 monthsHealthy volunteers can take part
- Conditions the study is for
- Children Born After Assisted Reproductive Technologies, Health Status, Child Development
- What is being tested?
- hemogram examination
- How many people
- 252 participants
- Where
- 1 siteKazakhstan
- Study dates
- 18 Oct 2023to 22 Jan 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 month to 60 months
- All sexes
- Healthy volunteers accepted
- Child
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
Who may be able to join
- 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.
Who cannot join
- intrauterine insemination
- ART programs with donor gametes
- surrogacy.
Trial locations and contacts
1 site in 1 country.
Kazakhstan1 site
Scientific Center of Pediatrics and Pediatric Surgery
Almaty, 050044
About this study
Official title: Health Status of Children Born After Assisted Reproductive Technologies With the Development of Prediction Model and Principles of Child Management.
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.
Read the 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
- 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.
- 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.
- 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.
- To develop a prediction model and algorithms for the management of children born after ART.
- Being tested
- hemogram examination
- 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
- Medical subject headings
- Infertility, Congenital Abnormalities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hemogram examinationDiagnostic test
Also called 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)
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.
| Study group | Role | What they receive |
|---|---|---|
| children born after ART | 120 children born after assisted reproductive technologies Receives: Diagnostic Test: hemogram examination | |
| children conceived spontaneously | 132 children conceived spontaneously Receives: Diagnostic Test: hemogram examination |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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
Measured: 1 day over which each participant is assessed
Secondary outcomes (1)
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)
Measured: 1 day over which each participant is assessed
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2023
- Study start18 Oct 2023
- Primary completion19 Jan 2024
- Study completion22 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Children Born After Assisted Reproductive TechnologiesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 252 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kazakhstan's Medical University "KSPH"
- Sponsor type
- University, hospital or other
- Collaborators
- Vyacheslav Notanovich Lokshin, Nurgalieva Zhanar Zhenisovna, Manzhuova Lyazzat Nurbapayevna, Abshekenova Aigerim Temirkhanovna, Valeria Nekhorosheva, Kusainova Farida Azimovna
- Responsible party
- Principal investigator, Sevara Ilmuratova, Kazakhstan's Medical University "KSPH"
- Investigators
- Sevara K Ilmuratova, Principal investigator, Kazakhstan Medical University "KSPH"Vyacheslav Lokshin, PhD, Study chair, International Clinical Centre of Reproduction "PERSONA"Lyazzat Manzhuova, PhD, Study chair, Scientific Center of Pediatrics and Pediatric SurgeryZhanar Nurgaliyeva, PhD, Principal investigator, Asfendiyarov Kazakh National Medical UniversityFarida Kussainova, MD, Principal investigator, Asfendiyarov Kazakh National Medical UniversityАygul Bazarbaeva, MD, Study director, Scientific Center of Pediatrics and Pediatric SurgeryValeriya Nekhorosheva, MD, Principal investigator, Institute of Reproductive MedicineAygerim Abshekenova, MD, Principal investigator, International Clinical Centre of Reproduction "PERSONA"
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06094998
- Sponsor's protocol ID
- ИРН AP14872103
- Status last verified
- Mar 2024
- First submitted
- 17 Oct 2023
- Last updated
- 7 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Health Status of Children Born After Assisted Reproductive Technologies With the Development of Prediction Model and Principles of Child Management.
- ClinicalTrials.gov ID
- NCT06094998
- Acronym / sponsor ID
- ИРН AP14872103
- Keywords
- children born after assisted reproductive technologies, health status, in vitro fertilization, assisted reproductive technologies, infertility, children's health, morbidity patterns, endocrine status
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 252 participants (actual)
- Lead sponsor
- Kazakhstan's Medical University "KSPH"University, hospital or other
- Collaborators
- Vyacheslav Notanovich Lokshin, Nurgalieva Zhanar Zhenisovna, Manzhuova Lyazzat Nurbapayevna, Abshekenova Aigerim Temirkhanovna, Valeria Nekhorosheva, Kusainova Farida Azimovna
- Study start
- 18 Oct 2023 (actual)
- Primary completion
- 19 Jan 2024 (actual)
- Study completion
- 22 Jan 2024 (actual)
- First posted
- 23 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- 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.
- 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.
- 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.
- To develop a prediction model and algorithms for the management of children born after ART.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| children born after ART | – | Diagnostic Test: hemogram examination120 children born after assisted reproductive technologies |
| children conceived spontaneously | – | Diagnostic Test: hemogram examination132 children conceived spontaneously |
Who may qualify
- Ages
- 1 month to 60 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- 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
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- intrauterine insemination
- ART programs with donor gametes
- surrogacy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| hemogram examinationAlso: 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)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. | Diagnostic test | children born after ART, children conceived spontaneously |
Primary outcome
Immune status of children born after assisted reproductive technologies
Time frame: 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
Time frame: 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
1 secondary outcome
Anthropometric measures
Time frame: 1 day over which each participant is assessed
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2024.
- Individual participant dataSharing planned: Undecided
Related trials for Children Born After Assisted Reproductive Technologies
Enrolling by invitationObservational study
Effects of Trophectoderm (TE) Biopsy on the Health and Development of Children Born After Preimplantation Genetic Testing (PGT) Cycles.
Preimplantation Genetic Testing (PGT), Frozen Embryo Transfer Cycle
Active, not recruitingObservational study
Reproductive Outcomes After Intracytoplasmic Sperm Injection (ICSI) With Surgically Retrieved Sperm.
Reproductive Technology, Assisted, IVF Outcomes
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sevara K Ilmuratova principal investigator
Kazakhstan Medical University "KSPH"
Vyacheslav Lokshin, PhD study chair
International Clinical Centre of Reproduction "PERSONA"
Lyazzat Manzhuova, PhD study chair
Scientific Center of Pediatrics and Pediatric Surgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Children Born After Assisted Reproductive Technologies and Health Status, run by Kazakhstan's Medical University "KSPH" at 1 site in Kazakhstan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Kazakhstan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Immune status of children born after assisted reproductive technologies (time frame: 1 day over which each participant is assessed). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2024.