Skip to content

PGTai Results for Embryos Cultured in Sequential Versus Single Step Media

Sequential Versus Single Step Culture Media in Relation to Euploidy Rates in PGTai Program

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04485910
Enrollment
200
Registered
2020-07-24
Start date
2019-12-01
Completion date
2021-06-01
Last updated
2020-07-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aneuploidy Rate, Infertility, Mosaicism

Keywords

PGT-A, Mosaicism, Single step media, Sequential media

Brief summary

A prospective cohort study undergoing ICSI at a private fertility center in Egypt

Detailed description

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.

Interventions

OTHERSingle step media

Usage of single step media in embryo culture

OTHERSequential media

Usage of sequential media in embryo culture

Sponsors

Ganin Fertility Center
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Intervention model description

Evaluating the embryonic development and PGTai results for embryos cultured in sequential media versus single step media.

Eligibility

Sex/Gender
ALL
Age
18 Years to 37 Years
Healthy volunteers
No

Inclusion criteria

* Female age ≤37 years with ≥ 8 mature oocytes * Male partner had normal semen parameters according to WHO 2010 * PGT-A was done at the blastocyst stage

Exclusion criteria

* sperm or oocyte donor * severe male factors according to WHO 2010

Design outcomes

Primary

MeasureTime frameDescription
Euploidy rate5:7 days of intracytoplasmic sperm injection(ICSI)percentage of euploid embryos/ total genetic tested embryos on blast stage
Mosaicism rate5:7 days of ICSIpercentage of mosaic embryos/ total genetic tested embryos on blast stage

Secondary

MeasureTime frameDescription
High quality of cleaved embryos72 hours of ICSIHigh quality D3 embryos according to Gardner's criteria / total cleaved embryos
Fertilization rate16:19 hours of ICSIPercentage of fertilized oocyte (appearance of two pronuclei) / Number of injected oocytes
High quality blast rate5:7 days of ICSIMorphological 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.
Blast formation rate5:7 days of ICSIPercentage of total blastocysts / Total cleaved embryos
Cleavage stage72 hours of ICSIPercentage of cleaved embryos/ total number of fertilized oocytes

Countries

Egypt

Contacts

Primary ContactManar M Hozyen, MSc.
manarnrc@gmail.com+201229483320
Backup ContactAmr Elshimy, BSc.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026