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

NCT05172336 | Unknown

• 1 other identifier: Elbanna_004
• Study Type: observational
• Target: 111
• Locations: 1 country
• Sites: 1

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).

Conditions

Fetal Cardiac Disorder

Keywords

fetal echocardiography

Outcome Measures

Primary Outcomes (1)

• 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: 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)

  2 weeks

Secondary Outcomes (1)

• 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

  8 weeks

Study Arms (3)

Assisted reproductive technology (Biopsied ICSI)

the study materials that will be used will include fetal ultrasound (fetal echocardiography) at 29 weeks ± 1week gestation.

Assisted reproductive technology (Non-Biopsied ICSI)

the study materials that will be used will include fetal ultrasound (fetal echocardiography) at 29 weeks ± 1week gestation.

Spontaneous conception (SC)

the study materials that will be used will include fetal ultrasound (fetal echocardiography) at 29 weeks ± 1week gestation.

Eligibility Criteria

• Age: 18 Years - 49 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Singleton pregnant women conceived by: * Assisted reproductive technology (Biopsied ICSI) * Assisted reproductive technology (Non-Biopsied ICSI) * Spontaneous conception (SC)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Wael Elbanna Clinic: lead
• National Research Centre, Egypt: collaborator

Study Sites (1)

National Research center

Cairo, Egypt

RECRUITING

Central Study Contacts

Wael El Banna, Consultant

CONTACT

01227760402; waelelbanna@drwaelelbanna.com

Manal Elhinnawi, specialist

CONTACT

01007970546; manalelhinnawi@hotmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 8, 2021
• First Posted: December 29, 2021
• Study Start: August 28, 2021
• Primary Completion: November 30, 2023
• Study Completion: December 30, 2023
• Last Updated: October 10, 2023

Record last verified: 2023-08

Locations

EG (1)