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

Wael Elbanna Clinic

Status: Enrolling

Conditions: Fetal Cardiac Disorder

Study type: Observational

Funder types: Other

Identifiers

NCT05172336

Elbanna_004

Details and patient eligibility

About

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).

Full 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.

Enrollment: 111 estimated patients

Sex: Female

Ages: 18 to 49 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

111 participants in 3 patient groups

Assisted reproductive technology (Biopsied ICSI)

Description:

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

Assisted reproductive technology (Non-Biopsied ICSI)

Description:

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

Spontaneous conception (SC)

Description:

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