Assessing fetal heart changes in pregnancies from assisted reproductive technology versus natural conception
Fetal Cardiac Remodeling in Singleton Pregnancies Conceived by Assisted Reproductive Technology (Biopsied and Non-Biopsied ICSI) Versus Those Normally Conceived
This study is trying to see if babies conceived through assisted reproductive technology have different heart changes compared to those conceived naturally, to help doctors understand fetal heart health better.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 111 (estimated) |
| Ages | 18 Years to 49 Years |
| Sex | Female |
| Sponsor | Wael Elbanna Clinic Academic / other |
| Locations | 1 site (Cairo) |
| Trial ID | NCT05172336 on ClinicalTrials.gov |
What this trial studies
This observational study evaluates fetal cardiac remodeling and dysfunction in singleton pregnancies conceived through assisted reproductive technology, specifically comparing biopsied and non-biopsied ICSI methods to those conceived spontaneously. The research aims to provide gynecologists with insights that could influence clinical decisions and best practices regarding fetal cardiac health. By conducting serial ultrasonographic examinations throughout the pregnancy, the study seeks to enrich the clinical evidence surrounding fetal cardiac conditions. The findings may also offer societal benefits by maximizing the advantages of assisted reproductive techniques.
Who should consider this trial
Good fit: Ideal candidates for this study are women over 18 years old with a singleton pregnancy who can attend regular ultrasound examinations.
Not a fit: Patients with multiple pregnancies, significant maternal medical conditions, or fetal malformations will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance understanding of fetal cardiac health in pregnancies conceived through assisted reproductive technology, leading to improved monitoring and management strategies.
How similar studies have performed: While there is ongoing research in fetal cardiac health, this specific comparison of assisted reproductive technology versus natural conception is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Cairo
- National Research center — Cairo, Egypt (Recruiting)
Study contacts
- Study coordinator: Wael El Banna, Consultant
- Email: waelelbanna@drwaelelbanna.com
- Phone: 01227760402
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.