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

Wael Elbanna Clinic

Status: Enrolling

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

Treatments: Procedure: Biopsied ICSI embryos (PGS)

Study type: Observational

Funder types: Other

Identifiers

NCT04280757

Elbanna_2020_02

Details and patient eligibility

About

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

Full 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

Enrollment: 420 estimated patients

Sex: Female

Ages: 20 to 40 years old

Volunteers: No Healthy Volunteers

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

Trial design

420 participants in 3 patient groups

Arm 1

Description:

Biopsied ICSI embryos

Treatment:

Procedure: Biopsied ICSI embryos (PGS)

Arm 2

Description:

Non biopsied ICSI embryos

Arm 3

Description:

Natural pregnancy embryos