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

NCT ID: NCT05172336

Last Updated: 2023-10-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

111 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-08-28

Study Completion Date

2023-12-30

Brief Summary

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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

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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.

Conditions

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Fetal Cardiac Disorder

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Assisted reproductive technology (Biopsied ICSI)

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

No interventions assigned to this group

Assisted reproductive technology (Non-Biopsied ICSI)

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

No interventions assigned to this group

Spontaneous conception (SC)

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

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

49 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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National Research Centre, Egypt

OTHER

Sponsor Role collaborator

Wael Elbanna Clinic

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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National Research center

Cairo, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Wael El Banna, Consultant

Role: CONTACT

01227760402

Manal Elhinnawi, specialist

Role: CONTACT

01007970546

Facility Contacts

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Wael Elbanna, consultant

Role: primary

01227760402

Manal Elhinnawi, specialist

Role: backup

01007970546

Other Identifiers

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Elbanna_004

Identifier Type: -

Identifier Source: org_study_id

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