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

Ambispective Comparative Cohort Study to Assess the Differences in Development and Growth Patterns of Biopsied and Non-Biopsied ICSI Embryos and Natural Pregnancy Embryos[BNB-ICSI Study]

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

Study Overview

• Status: Recruiting
• Conditions: Women Conceiving by: 1- ICSI-PGS 2- ICSI-non-PGS 3- Spontaneously Conceiving Women
• Intervention / Treatment: Procedure: Biopsied ICSI embryos (PGS)

Detailed Description

This study is an ambispective, comparative, cohort, observational, single-center study that will be conducted at Wael ElBanna Clinic, a private center that is well equipped for all procedures needed for ICSI and fetal medicine. After obtaining informed consent, the study participants' relevant medical records will be collected and reviewed. Data will be collected from the subjects' medical records. Data will be pooled and presented in aggregate, without identification of individual subjects.

The study materials that will be used will include blood tests and ultrasound. The study will involve three study arms:

• Arm 1: biopsied ICSI embryos (PGS)
• Arm 2: none biopsied ICSI embryos
• Arm 3: natural pregnancy embryos

• Study Type: Observational
• Enrollment (Estimated): 420

Contacts and Locations

• Study Contact: Name: wael Elbanna, specialist; Phone Number: 00201227760402; Email: waelelbanna@drwaelelbanna.com

Study Locations

• Egypt
  • Cairo, Egypt, 11865
    • Recruiting
    • Wael Elbanna Clinic
    • Contact: wael Elbanna, specialist; Phone Number: 00201227760402; Email: waelelbanna@drwaelelbanna.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 40 years (Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

The study population include women conceiving by:

1. ICSI-PGS
2. ICSI-non-PGS
3. Spontaneously conceiving women

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Arm 1; Biopsied ICSI embryos	Procedure: Biopsied ICSI embryos (PGS); Biopsied ICSI embryos (PGS)
Arm 2; Non biopsied ICSI embryos
Arm 3; Natural pregnancy embryos

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
First secondary endpoint	Miscarriage	At Labor
Second secondary endpoint	Live-birth weight	At Labor
Third secondary endpoint	Preterm labor	At Labor

Collaborators and Investigators

• Sponsor: Wael Elbanna Clinic
• Collaborators: Fetal Medicine Research Center, Spain
• Investigators: Study Director: Wael Elbanna, Specialist, Wael Elbanna Clinic; Principal Investigator: Eduard Gratacos, Specialist, fetal medicine; Principal Investigator: Manal El-Hinnawi, Specialist, Wael Elbanna Clinic

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2021
• Primary Completion (Estimated): November 1, 2023
• Study Completion (Estimated): August 1, 2024

Study Registration Dates

• First Submitted: February 10, 2020
• First Submitted That Met QC Criteria: February 20, 2020
• First Posted (Actual): February 21, 2020

Study Record Updates

• Last Update Posted (Actual): October 13, 2023
• Last Update Submitted That Met QC Criteria: October 12, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: biochemical parameters; fetal growth
• Other Study ID Numbers: Elbanna_2020_02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No