Enhancing Algorithms for the Management of Children Conceived by Assisted Reproductive Technologies Based on a Comprehensive Assessment of the Impact of Modern Methods of Conception on Their Health Status
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Physical growth parameters of children conceived via ART (ICSI and FET)
研究概览
简要总结
Research Methods and Ethical Issues
- 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.
- Description of the Experiments
Research Methods:
To achieve the goals of the study, the following stages are anticipated:
- 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
详细描述
2.1. Introduction The forthcoming scientific and technical project aims to investigate the physical, cognitive, and reproductive health of children conceived by advanced ART methods. By examining this expanding cohort of children in Kazakhstan and conducting a comprehensive health assessment, the project seeks to elucidate the potential implications of advanced ART techniques on the incidence of future health issues in these offspring. The findings from this study will enable proactive identification and intervention for any potential health deviations, ensuring appropriate referrals to specialists for further evaluation and treatment.
2.2. The project objective: To enhance the management strategies for children conceived via ART, informed by the study of the impact of modern conception methods on the health of the offspring, and the formulation of management principles tailored to this population.
2.3. Project Tasks:
To attain the overall project goal, the following tasks must be addressed:
- Analyze the influence of utilizing cryopreserved embryos in ART programs on the anthropometric characteristics and somatic health status of the offspring.
- Investigate the neurological condition of children under three years of age conceived by advanced assisted reproductive techniques (ICSI and FET).
- Evaluate the prevalence of urogenital pathology and hormonal profiles in male children under three years of age who were born using the ICSI method due to male factor infertility, in comparison to those conceived through classic IVF.
- Examine the relationship between the reproductive health of fathers and their sons born after ICSI.
- Assess the health status of children under three years of age born after successful ART programs, incorporating anamnestic data from their mothers, including medication usage before and during pregnancy.
- Develop a predictive model and management algorithms for children conceived by various ART methods.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 0 Months 至 3 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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).
排除标准
- 未提供
结局指标
主要结局
Physical growth parameters of children conceived via ART (ICSI and FET)
时间窗: At birth (medical records) and at clinical assessment conducted at the child's age at enrollment (up to 36 months of age).
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).
Psychomotor and neurodevelopmental status of children conceived via ART (ICSI and FET)
时间窗: At a single clinical assessment conducted at the child's age at enrollment (up to 36 months of age).
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).
Urogenital and reproductive system development in children conceived via ART (ICSI and FET)
时间窗: At a single clinical assessment conducted at the child's age at enrollment (up to 36 months of age).
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).
次要结局
- 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).)
- Presence of neurosonography abnormalities(At a single assessment conducted at the child's age at enrollment (up to 12 months), or extracted from existing medical records if the examination was previously performed.)
- Prevalence of urogenital abnormalities(At a single clinical assessment conducted at the child's age at enrollment (up to 36 months of age).)
- Serum Inhibin B concentration(At a single clinical assessment conducted at the child's age at enrollment (up to 36 months of age).)
- Serum AMH (Anti-Müllerian Hormone) concentration(At a single clinical assessment conducted at the child's age at enrollment (up to 36 months of age).)
- Association between parental medical history and offspring health parameters(At the child's enrollment visit (up to 36 months of age), using parental medical history collected at the same visit or extracted from medical records.)
研究者
Sevara Ilmuratova
Senior researcher
Kazakhstan's Medical University "KSPH"