Skip to content

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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05172336
Enrollment
111
Registered
2021-12-29
Start date
2021-08-28
Completion date
2023-12-30
Last updated
2023-10-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fetal Cardiac Disorder

Keywords

fetal echocardiography

Brief summary

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

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.

Interventions

None listed

Sponsors

National Research Centre, Egypt
CollaboratorOTHER
Wael Elbanna Clinic
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 49 Years
Healthy volunteers
Yes

Inclusion criteria

1. Women aged \>18 years 2. Singleton pregnancy 3. Women who are willing and able to attend serial ultrasonographic examinations during the whole pregnancy 4. Women willing to sign an informed consent

Exclusion criteria

1. Multiple pregnancies; more than one fetus 2. 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 3. Diagnosis of fetal malformations; fetus with a structural or chromosomal anomaly 4. 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. 5. Smokers or drug/alcohol women 6. Inability to understand and provide written informed consent

Design outcomes

Primary

MeasureTime frameDescription
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)2 weeksRecording the fetal echocardiography data including: 1. 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 2. 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) 3. Systolic function data * Left ejection fraction (%) * Right ejection fraction (%) * MAPSE (mm) * TAPSE (mm) 4. Diastolic function data * Mitral E/A ratio * Tricuspid E/A ratio * Left isovolumic relaxation time (ms) 5. Gestational age at ultrasound examination (weeks)

Secondary

MeasureTime frameDescription
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 (SC8 weeks1. Maternal characteristics * Age (years) * BMI (kg/m2) * Primiparous 2. Pregnancy complications * Pre-eclampsia * Corticoid exposure * Gestational diabetes 3. Delivery data * GA (weeks) * Cesarean section * Gender * Birth weight (g) * Birth weight centile * SGA (small-for gestational age) 4. Neonatal outcome data * Admission to NICU * Major neonatal morbidity\*

Countries

Egypt

Contacts

Primary ContactWael El Banna, Consultant
waelelbanna@drwaelelbanna.com01227760402
Backup ContactManal Elhinnawi, specialist
manalelhinnawi@hotmail.com01007970546

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026