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

Fetal Cardiac Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05172336
• Other study ID #: Elbanna_004
• Status: Recruiting
• Start date: August 28, 2021
• Est. completion date: December 30, 2023

Study information

• Verified date: August 2023
• Source: Wael Elbanna Clinic
• Contact: Wael El Banna, Consultant
• Phone: 01227760402
• Email: waelelbanna[@]drwaelelbanna.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 111
• Est. completion date: December 30, 2023
• Est. primary completion date: November 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 49 Years

Eligibility

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

Related Conditions & MeSH terms

• Fetal Cardiac Disorder
• Heart Diseases

Locations

Country	Name	City	State
Egypt	National Research center	Cairo

Sponsors (2)

Lead Sponsor	Collaborator
Wael Elbanna Clinic	National Research Centre, Egypt

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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