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

October 9, 2023 updated by: Wael Elbanna Clinic
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).

Study Overview

Status

Recruiting

Conditions

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.

Study Type

Observational

Enrollment (Estimated)

111

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Egypt
      • Cairo, Egypt
        • Recruiting
        • National Research Center
        • Principal Investigator:
          • wael Elbanna, consultant
        • Sub-Investigator:
          • Manal Elhinnawi, Specialist
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 49 years (Adult)

Accepts Healthy Volunteers

Yes

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)

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Time Frame: 2 weeks

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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Time Frame: 8 weeks

  1. Maternal characteristics

    • Age (years)
    • BMI (kg/m2)
    • Primiparous

  2. Pregnancy complications

    • Pre-eclampsia
    • Corticoid exposure
    • Gestational diabetes

  3. Delivery data

    • GA (weeks)
    • Cesarean section
    • Gender
    • Birth weight (g)
    • Birth weight centile
    • SGA (small-for gestational age)

  4. Neonatal outcome data

    • Admission to NICU
    • Major neonatal morbidity*
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wael Elbanna Clinic

Collaborators

National Research Centre, Egypt

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 28, 2021

Primary Completion (Estimated)

November 30, 2023

Study Completion (Estimated)

December 30, 2023

Study Registration Dates

First Submitted

December 8, 2021

First Submitted That Met QC Criteria

December 27, 2021

First Posted (Actual)

December 29, 2021

Study Record Updates

Last Update Posted (Actual)

October 10, 2023

Last Update Submitted That Met QC Criteria

October 9, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Elbanna_004

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Fetal Cardiac Disorder

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in South Korea

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe