NCT07278960 Enhancing Management Algorithms for Children Conceived Via Assisted Reproductive Technologies
| NCT ID | NCT07278960 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Kazakhstan's Medical University "KSPH" |
| Condition | Children |
| Study Type | OBSERVATIONAL |
| Enrollment | 300 participants |
| Start Date | 2025-10-01 |
| Primary Completion | 2026-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 300 participants in total. It began in 2025-10-01 with a primary completion date of 2026-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Research Methods and Ethical Issues 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. Description of the Experiments Research Methods: To achieve the goals of the study, the following stages are anticipated: 1. Retrospective Analysis of Anamnestic Data: This stage involves studying the relationship between the physical status and morbidity structure of 300 children under the age of three, who were conceived by advanced ART methods. Additionally, the medical history of their mothers regarding the use of various medications during pregnancy-such as estrogen, progesterone, thyroid hormones, antithyroid hormones, vitamins, microelements, and aspirin-will be examined. To facilitate this analysis, individual registration cards will be developed, approved by the ethics committee, and ratified by the Academic Council. The data will be submitted using Google Forms, followed by the inclusion of copyright information into the state register. 2. Evaluation of Anthropometric Data: This stage will assess the anthropometric data of 300 children under three years of age, focusing on those born after FET or fresh embryo transfer (Fresh-ET). Measurements will include weight, height, and head and chest circumference at the time of examination. Measurements for children under one year will utilize scales with a pan balance, a horizontal stadiometer, and a measuring tape. For children over one year, floor electronic scales, a vertical stadiometer, and a centimeter tape will be employed. 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. 3. Study of Psychomotor Development: The psychomotor development of the 300 children under three years of age conceived via IVF or ICSI in fresh or frozen cycles will be assessed. This evaluation will employ standardized instruments such as the R. Griffiths Mental Development Scale and Denver Developmental Screening Tests. For children under one year, neurosonography will be conducted to assess brain structures, and retrospective results for children over one year of age will be extracted from medical records. The assessment aims to determine the functions of the nervous system utilizing the aforementioned standardized scales, focusing on various developmental parameters, including motor skills, social adaptation, communication abilities, and play skills. Scores will be compiled to ascertain overall developmental levels. The Denver II developmental screening test is specifically designed to assess children from birth to six years of age. It enhances diagnostic capabilities and evaluates several critical parameters, including: 1) personal and social characteristics, which examine the child's interactions with others and their ability to meet personal needs; 2) the development of gross and fine motor skills; 3) the development of both motor and sensory speech; and 4) an assessment of the child's behavior during the evaluation process. In cases where children are identified as being in the "risk group," a consultation with a neurologist is planned to establish examination protocols and identify the etiopathogenetic basis for potential developmental disorders. Standard methods of neurological examination will be utilized to assess the development of motor, sensory, cognitive, speech, emotional, communicative, and behavioral parameters in conjunction with anamnestic data and the overall state of somatic health. 4. Assessment of 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. 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. 3\) Methods of Data Collection and Processing Data Collection Sources of Information: Data will be sourced from the International clinical center of the reproductology "PERSONA" and Institute of Reproductive Medicine (IRM clinic), in addition to direct examinations of participants based
Eligibility Criteria
Inclusion Criteria: 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).
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07278960 clinical trial?
This trial is open to participants of all sexes, aged 0 Months or older, up to 3 Years, studying Children. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07278960 currently recruiting?
Yes, NCT07278960 is actively recruiting participants. Contact the research team at ilmuratova.s@gmail.com for enrollment information.
Where is the NCT07278960 trial being conducted?
This trial is being conducted at Almaty, Kazakhstan.
Who is sponsoring the NCT07278960 clinical trial?
NCT07278960 is sponsored by Kazakhstan's Medical University "KSPH". The trial plans to enroll 300 participants.