Enhancing Management Algorithms for Children Conceived Via Assisted Reproductive Technologies

NCT07278960 | Recruiting DMC

• 1 other identifier: AP26100341
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

Research Methods and Ethical Issues

1. 1.Main Scientific Questions and Hypotheses of the Project The primary objective of this project is to investigate the impact of advanced ART methods on the health status of children. The central scientific questions being addressed include: What are the consequences of ICSI and FET on the physical, cognitive, and reproductive health of children? The underlying hypothesis posits that children conceived by advanced ART methods may present with health indicators that deviate from the established norms.
2. 2.Description of the Experiments
3. 3.Retrospective Analysis of Anamnestic Data:
4. 4.Evaluation of Anthropometric Data:
5. 5.Study of Psychomotor Development:
6. 6.Assessment of Reproductive Health:

Conditions

Children; ART; Anthropometric Characteristics; Somatic Health Status; Neurological Condition; Urogenital Pathology

Keywords

ART; health status; children after ART; offspring; urogenital pathology; anthropometric charachteristics; neurological conditions

Outcome Measures

Primary Outcomes (3)

• Physical growth parameters of children conceived via ART (ICSI and FET)

  Evaluation of physical growth using standardized anthropometric measures: weight (kg), length/height (cm), and head circumference (cm), assessed against WHO Child Growth Standards. Unit of Measure: Z-scores (weight-for-age, length-for-age, head-circumference-for-age).

  At birth (medical records) and at clinical assessment conducted at the child's age at enrollment (up to 36 months of age).

• Psychomotor and neurodevelopmental status of children conceived via ART (ICSI and FET)

  Assessment of cognitive, motor, language, and social-emotional development using the Bayley Scales of Infant and Toddler Development, Fourth Edition (Bayley-IV). Scores range from 40 to 160; higher scores indicate better developmental performance. Unit of Measure: Bayley-IV composite scores (Cognitive, Motor, Language).

  At a single clinical assessment conducted at the child's age at enrollment (up to 36 months of age).

• Urogenital and reproductive system development in children conceived via ART (ICSI and FET)

  Clinical examination and ultrasonographic assessment of urogenital system development performed by pediatric urologists/gynecologists. Parameters include presence or absence of congenital anomalies (e.g., cryptorchidism, hypospadias), uterus/ovary/testis morphology, and developmental measurements as per pediatric normative standards. Unit of Measure: Incidence of anomalies (yes/no), organ measurements (mm).

  At a single clinical assessment conducted at the child's age at enrollment (up to 36 months of age).

Secondary Outcomes (10)

• Weight-for-Age Z-Score

  At birth (medical records) and at clinical assessment conducted at the child's age at enrollment (up to 36 months of age).

• Height-for-Age Z-Score

  At birth (medical records) and at clinical assessment conducted at the child's age at enrollment (up to 36 months of age).

• Head Circumference-for-Age Z-Score

  At birth (medical records) and at clinical assessment conducted at the child's age at enrollment (up to 36 months of age).

• Psychomotor development score (Griffiths Scales)

  At a single clinical assessment conducted at the child's age at enrollment (up to 36 months of age).

• Developmental screening result (Denver II Test)

  At a single clinical assessment conducted at the child's age at enrollment (up to 36 months of age).

Study Arms (2)

children born after ICSI

Anthropometric data: will include weight, height, and head and chest circumference at the time of examination. Birth anthropometric data will be sourced retrospectively, while the WHO Child Growth Standards will be utilized to evaluate weight, height, head, and chest circumference relative to age and gender. Psychomotor development: This evaluation will employ standardized instruments such as the R. Griffiths Mental Development Scale and Denver Developmental Screening Tests. Reproductive Health: The study will also evaluate the effect of ICSI, particularly in cases of male infertility, on the reproductive health and development of 200 male children under three years of age, in comparison with children conceived via classic IVF. This evaluation will involve objective examinations conducted by a pediatric andrologist to investigate the prevalence of urogenital pathology, , supplemented by ultrasounds of the scrotum, kidneys, and bladder.

Diagnostic Test: Inhibin B; Diagnostic Test: Anti-Müllerian Hormone (AMH)

children born after IVF

Anthropometric data: will include weight, height, and head and chest circumference at the time of examination. Birth anthropometric data will be sourced retrospectively, while the WHO Child Growth Standards will be utilized to evaluate weight, height, head, and chest circumference relative to age and gender. Psychomotor development: This evaluation will employ standardized instruments such as the R. Griffiths Mental Development Scale and Denver Developmental Screening Tests. Reproductive Health: The study will also evaluate the effect of ICSI, particularly in cases of male infertility, on the reproductive health and development of 200 male children under three years of age, in comparison with children conceived via classic IVF. This evaluation will involve objective examinations conducted by a pediatric andrologist to investigate the prevalence of urogenital pathology, , supplemented by ultrasounds of the scrotum, kidneys, and bladder.

Diagnostic Test: Inhibin B; Diagnostic Test: Anti-Müllerian Hormone (AMH)

Interventions

Anti-Müllerian Hormone (AMH) DIAGNOSTIC_TEST

The study will also evaluate the effect of ICSI, particularly in cases of male infertility, on the reproductive health and development of 200 male children under three years of age, in comparison with children conceived via classic IVF. This evaluation will involve objective examinations conducted by a pediatric andrologist to investigate the prevalence of urogenital pathology, supplemented by ultrasounds of the scrotum, kidneys, and bladder. Additionally, hormonal status will be assessed by Inhibin B and Anti-Müllerian Hormone (AMH). Anamnestic data will be collected to explore the relationship between the reproductive health of fathers and their sons born after ICSI.

children born after ICSI; children born after IVF

Inhibin B DIAGNOSTIC_TEST

The study will also evaluate the effect of ICSI, particularly in cases of male infertility, on the reproductive health and development of 200 male children under three years of age, in comparison with children conceived via classic IVF. This evaluation will involve objective examinations conducted by a pediatric andrologist to investigate the prevalence of urogenital pathology, supplemented by ultrasounds of the scrotum, kidneys, and bladder. Additionally, hormonal status will be assessed by Inhibin B and Anti-Müllerian Hormone (AMH). Anamnestic data will be collected to explore the relationship between the reproductive health of fathers and their sons born after ICSI.

children born after ICSI; children born after IVF

Eligibility Criteria

• Age: 0 Months - 3 Years
• Sex: all
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

The study population will consist of children under three years of age who were conceived via assisted reproductive technologies (ART) in the Republic of Kazakhstan, along with their biological parents. The research cohort will include children conceived through advanced ART methods - specifically intracytoplasmic sperm injection (ICSI) and frozen embryo transfer (FET) - as well as a comparison group of children conceived via conventional IVF and fresh embryo transfer (Fresh-ET). A total of approximately 300 children (including at least 200 male participants for reproductive health analysis) will be recruited from reproductive medicine centers, pediatric hospitals, and outpatient clinics across Kazakhstan. Medical records of participating mothers will also be used for retrospective data collection regarding conception details, pregnancy course, and perinatal outcomes.

You may qualify if:

• For children:
• Born as a result of an ART program (IVF, ICSI, FET, or Fresh-ET).
• Age at the time of assessment: from birth up to 36 months.
• Availability of complete perinatal and medical documentation, including ART cycle characteristics and neonatal outcomes.
• Informed consent provided by parents or legal guardians for participation in the study and for biological sample collection (where applicable).
• For mothers:
• History of pregnancy achieved through ART within the territory of Kazakhstan.
• Availability of data on pharmacological treatment before and during pregnancy (e.g., hormonal therapy, antithyroid drugs, vitamins, micronutrients).
• Willingness to provide anamnestic and perinatal information, and consent for access to medical records.
• For fathers (in ICSI subgroup):
• Documented infertility factor necessitating ICSI.
• Agreement to provide relevant medical history and participate in comparative analyses (e.g., endocrine or reproductive parameters of father-son pairs).

Sponsors & Collaborators

• Kazakhstan's Medical University "KSPH": lead
• International Clinical Center for Reproductology "PERSONA": collaborator

Study Sites (1)

Международный клинический центр репродуктологии Persona

Almaty, 050060, Kazakhstan

RECRUITING

Central Study Contacts

Sevara Ilmuratova, PhD

CONTACT

+77778017305; ilmuratova.s@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior researcher

Study Record Dates

• First Submitted: November 14, 2025
• First Posted: December 12, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): November 30, 2027
• Last Updated: December 12, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

KA (1)