PGTai Results for Embryos Cultured in Sequential Versus Single Step Media

Not Applicable

• Conditions: Infertility; Aneuploidy Rate; Mosaicism
• Interventions: Other: Sequential media; Other: Single step media

• Registration Number: NCT04485910
• Lead Sponsor: Ganin Fertility Center

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.

Study Timeline

• Study Start: 2019-12-01
• Status Verified: 2020-06
• Study First Submitted: 2020-07-22
• Study First Submitted QC: 2020-07-22
• Last Update Submitted: 2020-07-22
• Study First Posted: 2020-07-24
• Last Update Posted: 2020-07-24
• Primary Completion: 2021-03-01
• Study Completion: 2021-06-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sequential media	Sequential media	Embryos cultured in sequential media
Single step media	Single step media	Embryos cultured in single step media

Primary Outcome Measures

Name	Time	Method
Euploidy rate	5:7 days of intracytoplasmic sperm injection(ICSI)	percentage of euploid embryos/ total genetic tested embryos on blast stage
Mosaicism rate	5:7 days of ICSI	percentage of mosaic embryos/ total genetic tested embryos on blast stage

Secondary Outcome Measures

Name	Time	Method
Fertilization rate	16:19 hours of ICSI	Percentage of fertilized oocyte (appearance of two pronuclei) / Number of injected oocytes
High quality of cleaved embryos	72 hours of ICSI	High quality D3 embryos according to Gardner's criteria / total cleaved embryos
Blast formation rate	5:7 days of ICSI	Percentage of total blastocysts / Total cleaved embryos
High quality blast rate	5:7 days of ICSI	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.
Cleavage stage	72 hours of ICSI	Percentage of cleaved embryos/ total number of fertilized oocytes

Trial Locations

Locations (1)

Ganin Fertility Center; 🇪🇬 Cairo, Egypt