Comparing embryos from different conception methods
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]
This study looks at how embryos created through different methods, including a special sperm injection and natural conception, grow and develop to see if taking a small sample from them affects their progress.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 420 (estimated) |
| Ages | 20 Years to 40 Years |
| Sex | Female |
| Sponsor | Wael Elbanna Clinic Academic / other |
| Locations | 1 site (Cairo) |
| Trial ID | NCT04280757 on ClinicalTrials.gov |
What this trial studies
This observational study compares the growth and biochemical parameters of embryos conceived through intracytoplasmic sperm injection (ICSI) with and without preimplantation genetic screening (PGS) to those from natural pregnancies. It aims to determine if biopsying embryos affects their development and to analyze prenatal biochemical parameters across these groups. The study will collect and review medical records from participants and will involve blood tests and ultrasounds to gather relevant data. Participants will be grouped into three arms: biopsied ICSI embryos, non-biopsied ICSI embryos, and naturally conceived embryos.
Who should consider this trial
Good fit: Ideal candidates are singleton pregnant women aged 20 to 40 who are non-smokers and have a BMI between 19 and 40.
Not a fit: Patients with systemic diseases, uterine abnormalities, or confirmed hematological and immunological disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into the effects of genetic screening on embryo development, potentially improving assisted reproductive techniques.
How similar studies have performed: While the approach of comparing biopsied and non-biopsied embryos is gaining interest, this specific comparative analysis is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Cairo
- wael Elbanna Clinic — Cairo, Egypt (Recruiting)
Study contacts
- Principal investigator: Eduard Gratacos, Specialist — fetal medicine
- Study coordinator: wael Elbanna, Specialist
- Email: waelelbanna@drwaelelbanna.com
- Phone: 00201227760402
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.