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A prospective cohort study undergoing ICSI at a private fertility center in Egypt
Purpose:
To evaluate PGTai results for embryos cultured in sequential versus single step media.
Method:
Injected oocytes will divided between Continuous Single Culture-NX media (CSC- NX) with 10% SSS the first group (Irvine, USA) and the other group will be cultured in sequential cleavage and blastocyst media with 10% SPS (SAGE, Denmark).
All blastocytes with 4BB quality and better according to Gardner's criteria 1999 will go through PGTA procedures with PGTai confirmation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single step media | Active Comparator | Embryos cultured in single step media |
|
| Sequential media | Active Comparator | Embryos cultured in sequential media |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Single step media | Other | Usage of single step media in embryo culture |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Euploidy rate | percentage of euploid embryos/ total genetic tested embryos on blast stage | 5:7 days of intracytoplasmic sperm injection(ICSI) |
| Mosaicism rate | percentage of mosaic embryos/ total genetic tested embryos on blast stage | 5:7 days of ICSI |
| Measure | Description | Time Frame |
|---|---|---|
| Fertilization rate | Percentage of fertilized oocyte (appearance of two pronuclei) / Number of injected oocytes | 16:19 hours of ICSI |
| Cleavage stage | Percentage of cleaved embryos/ total number of fertilized oocytes |
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Inclusion Criteria:
Exclusion Criteria:
Female age ≤37 years with ≥ 8 mature oocytes
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Manar M Hozyen, MSc. | Contact | +201229483320 | manarnrc@gmail.com | |
| Amr Elshimy, BSc. | Contact |
| Name | Affiliation | Role |
|---|---|---|
| Manar M Hozyen, MSc. | Ganin Fertility Center | Principal Investigator |
| Amr Elshimy, BSc. | Ganin Fertility Center | Principal Investigator |
| Hanaa Elkhader, BSc. |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ganin Fertility Center | Recruiting | Cairo | 11728 | Egypt |
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| ID | Term |
|---|---|
| D007246 | Infertility |
| ID | Term |
|---|---|
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
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Evaluating the embryonic development and PGTai results for embryos cultured in sequential media versus single step media.
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| Sequential media |
| Other |
Usage of sequential media in embryo culture |
|
| 72 hours of ICSI |
| High quality of cleaved embryos | High quality D3 embryos according to Gardner's criteria / total cleaved embryos | 72 hours of ICSI |
| Blast formation rate | Percentage of total blastocysts / Total cleaved embryos | 5:7 days of ICSI |
| High quality blast rate | Morphological grading of trophectoderm and Inner cell mass using Gardner's criteria 1999, from grade A and B ( A is the highest quality). Total high grade embryos/ total blast embryos. | 5:7 days of ICSI |
| Ganin Fertility Center |
| Principal Investigator |
| Hosam Zaki, MSc. | Ganin Fertility Center | Study Chair |