Fetal Cardiac Remodeling in Singleton Pregnancies Conceived by Assisted Reproductive Technology (Biopsied and Non-Biopsied ICSI) Versus Those Normally Conceived

Study Overview
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Brief Summary
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The study aims to assess the presence of fetal cardiac remodeling and dysfunction in singleton pregnancies conceived by assisted reproductive technology (Biopsied and Non-Biopsied ICSI) as compared with those conceived spontaneously (SC).

Detailed Description
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For gynecologists, reaching a conclusion about fetal cardiac remodeling and dysfunction in singleton pregnancies conceived by assisted reproductive technology (Biopsied and Non-Biopsied ICSI) or conceived spontaneously (SC) that would influence the clinical decision and best practice. Besides enriching the clinical evidence in fetal cardiac remodeling and dysfunction. For society, the conclusion and recommendation shall maximize the benefits and managing the benefits of the technique used. Moreover, providing more information for fetal cardiac remodeling and dysfunction.

Official Title
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Fetal Cardiac Remodeling in Singleton Pregnancies Conceived by Assisted Reproductive Technology (Biopsied and Non-Biopsied ICSI) Versus Those Normally Conceived

Conditions
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Fetal Cardiac Disorder

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women aged >18 years Singleton pregnancy Women who are willing and able to attend serial ultrasonographic examinations during the whole pregnancy Women willing to sign an informed consent Exclusion Criteria: Multiple pregnancies; more than one fetus Any maternal medical disease, including asthma, chronic hypertension, diabetes mellitus, heart disease, extracardiac anomalies, human immunodeficiency virus or hepatitis infection, immunological disorders, lupus, and thyroid disease Diagnosis of fetal malformations; fetus with a structural or chromosomal anomaly Fetus with Small-for-Gestational-Age (SGA) or intrauterine Growth Restriction (IUGR) (a fetal weight that is below the 10th percentile for gestational age) as determined through an ultrasound. Smokers or drug/alcohol women Inability to understand and provide written informed consent

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 49 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Assisted reproductive technology (Biopsied ICSI)<br>the study materials that will be used will include fetal ultrasound (fetal echocardiography) at 29 weeks ± 1week gestation. | |
| Assisted reproductive technology (Non-Biopsied ICSI)<br>the study materials that will be used will include fetal ultrasound (fetal echocardiography) at 29 weeks ± 1week gestation. | |
| Spontaneous conception (SC)<br>the study materials that will be used will include fetal ultrasound (fetal echocardiography) at 29 weeks ± 1week gestation. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the presence of fetal cardiac remodeling and dysfunction in singleton pregnancies conceived by assisted reproductive technology (Biopsied and Non-Biopsied ICSI) as compared with those conceived spontaneously (SC) | Recording the fetal echocardiography data including: Standard fetoplacental data Estimated fetal weight (g) Estimated fetal weight (centile) Uterine artery mean PI Umbilical artery PI Middle cerebral artery PI Cerebroplacental ratio Ductus venosus PI Aortic isthmus PI Cardiac morphometric data Cardiothoracic ratio Left atrial/heart ratio Right atrial/heart ratio Left ventricular sphericity index Right ventricular sphericity index Left ventricular free wall thickness (mm) Septal wall thickness (mm) Right ventricular free wall thickness (mm) Myocardial Performance Index (MPI) Systolic function data Left ejection fraction (%) Right ejection fraction (%) MAPSE (mm) TAPSE (mm) Diastolic function data Mitral E/A ratio Tricuspid E/A ratio Left isovolumic relaxation time (ms) Gestational age at ultrasound examination (weeks) | 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To describe the baseline and perinatal characteristics in singleton fetuses conceived by assisted reproductive technology (Biopsied and Non-Biopsied ICSI) as compared with those conceived spontaneously (SC | Maternal characteristics Age (years) BMI (kg/m2) Primiparous Pregnancy complications Pre-eclampsia Corticoid exposure Gestational diabetes Delivery data GA (weeks) Cesarean section Gender Birth weight (g) Birth weight centile SGA (small-for gestational age) Neonatal outcome data Admission to NICU Major neonatal morbidity* | 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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fetal echocardiography