Comparison Between Biopsied and Non-biopsied Intracytoplasmatic Sperm Injection (ICSI) Embryos and Natural Pregnancy Embryos

NCT04280757 | Unknown

• 1 other identifier: Elbanna_2020_02
• Study Type: observational
• Target: 420
• Locations: 1 country
• Sites: 1

Brief Summary

As Pre Implantation Genetic Screening (PGS) becomes now a replacement modality and trend gaining popularity among physicians and patients on claiming its ability to settle on the simplest genetically normal embryo, so it had been logical to review if taking cells from the embryo in its early development will or won't affect its growth as compared to the previous standard technique of ICSI and in comparison to a normally conceived embryos the study also will question if the parameters of the prenatal biochemical standard parameters will have any differences if the embryo is already genetically tested embryo and compare these parameters with non PGS embryos and normally conceived embryos. This study is an ambispective, comparative, cohort, observational, single-center study. The study participants' relevant medical records will be collected and reviewed for the retrospective subjects and after obtaining informed consent for the prospective subjects. The study materials that will be used will include blood tests and ultrasound. The study will involve three study arms

Conditions

Women Conceiving by: 1- ICSI-PGS 2- ICSI-non-PGS 3- Spontaneously Conceiving Women

Keywords

fetal growth; biochemical parameters

Outcome Measures

Primary Outcomes (3)

• First primary endpoint

  \- Early ultrasound measurements "yolk sac (YS), mean sac diameter (MSD), crown rump length (CRL)", different maternal serum prenatal screening markers for growth and aneuploidy between the three arms\* of the study

  At pregnancy

• Second primary endpoint

  \- Second trimetric U/S measurements of fetal growth : U/S measurements of fetal growth using growth curves and measurement of FPI (fetal ponderal index) and fetal weight percentile

  At 2nd trimester of pregnancy

• Third primary endpoint

  \- Third-trimester U/S measurements of fetal growth : U/S measurements of fetal growth using growth curves and measurement of FPI (fetal ponderal index) and fetal weight percentile

  At 3rd trimester of pregnancy

Secondary Outcomes (3)

• First secondary endpoint

  At Labor

• Second secondary endpoint

  At Labor

• Third secondary endpoint

  At Labor

Study Arms (3)

Arm 1

Biopsied ICSI embryos

Procedure: Biopsied ICSI embryos (PGS)

Arm 2

Non biopsied ICSI embryos

Arm 3

Natural pregnancy embryos

Interventions

Biopsied ICSI embryos (PGS) PROCEDURE

Biopsied ICSI embryos (PGS)

Arm 1

Eligibility Criteria

• Age: 20 Years - 40 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

The study population include women conceiving by: 1. ICSI-PGS 2. ICSI-non-PGS 3. Spontaneously conceiving women

You may qualify if:

• Singleton pregnant women
• Pregnancy confirmation by ultrasound at week 6 of gestation either by normal pregnancy or ICSI (Biopsied and Non-Biopsied)
• Between the age of 20 and 40 years.
• Non-smokers.
• BMI must be between 19 and 40

You may not qualify if:

• Those with anti-phospholipid syndrome confirmed by serological tests
• Those with any hematological and immunological disorders
• Women with uterine abnormalities have not been corrected.
• Women with systemic diseases that cannot be controlled or managed

Sponsors & Collaborators

• Wael Elbanna Clinic: lead
• Fetal Medicine Research Center, Spain: collaborator

Study Sites (1)

wael Elbanna Clinic

Cairo, 11865, Egypt

RECRUITING

MeSH Terms

Interventions

Phosphatidylglycerols

Intervention Hierarchy (Ancestors)

Glycerophospholipids; Phosphatidic Acids; Glycerophosphates; Phospholipids; Membrane Lipids; Lipids

Study Officials

• Wael Elbanna, Specialist

  Wael Elbanna Clinic

  STUDY DIRECTOR

• Eduard Gratacos, Specialist

  fetal medicine

  PRINCIPAL INVESTIGATOR

• Manal El-Hinnawi, Specialist

  Wael Elbanna Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

wael Elbanna, Specialist

CONTACT

00201227760402; waelelbanna@drwaelelbanna.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: European board fellow of obstetrics and gynecology

Study Record Dates

• First Submitted: February 10, 2020
• First Posted: February 21, 2020
• Study Start: July 1, 2021
• Primary Completion: November 1, 2023
• Study Completion: August 1, 2024
• Last Updated: October 13, 2023

Record last verified: 2023-10

Locations

EG (1)