Clinical trial NCT04280757: Comparison Between Biopsied and Non-biopsied Intracytoplasmatic Sperm Injection (ICSI) Embryos and Natural Pregnancy Embryos
Official title: 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]
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Women Conceiving by: 1- ICSI-PGS 2- ICSI-non-PGS 3- Spontaneously Conceiving Women
Keywords: fetal growth
biochemical parameters
Lead sponsor: Wael Elbanna Clinic
Sponsor class: OTHER
Collaborators: name: Fetal Medicine Research Center, Spain
First posted: 2020-02-21
Enrollment: 420
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: The study population include women conceiving by:

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

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

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

Eligibility criteria: 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

Primary outcomes:
measure: First primary endpoint
timeFrame: At pregnancy
measure: Second primary endpoint
timeFrame: At 2nd trimester of pregnancy
measure: Third primary endpoint
timeFrame: At 3rd trimester of pregnancy
Secondary outcomes:
measure: First secondary endpoint
timeFrame: At Labor
measure: Second secondary endpoint
timeFrame: At Labor
measure: Third secondary endpoint
timeFrame: At Labor
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: wael Elbanna Clinic
Study officials:
affiliation: Wael Elbanna Clinic
name: Wael Elbanna, Specialist
role: STUDY_DIRECTOR
affiliation: fetal medicine
name: Eduard Gratacos, Specialist
role: PRINCIPAL_INVESTIGATOR
affiliation: Wael Elbanna Clinic
name: Manal El-Hinnawi, Specialist
role: PRINCIPAL_INVESTIGATOR
References: