Clinical trial NCT05172336: Fetal Cardiac Remodeling in Singleton Pregnancies Conceived by Assisted Reproductive Technology (Biopsied and Non-Biopsied ICSI) Versus Those Normally Conceived
Official title: Fetal Cardiac Remodeling in Singleton Pregnancies Conceived by Assisted Reproductive Technology (Biopsied and Non-Biopsied ICSI) Versus Those Normally Conceived
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Fetal Cardiac Disorder
Keywords: fetal echocardiography
Lead sponsor: Wael Elbanna Clinic
Sponsor class: OTHER
Collaborators: name: National Research Centre, Egypt
First posted: 2021-12-29
Enrollment: 111
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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)

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.

Eligibility criteria: 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

Primary outcomes:
measure: 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)
timeFrame: 2 weeks
Secondary outcomes:
measure: 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
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: National Research center
Study officials:
References: