PGTai Results for Embryos Cultured in Sequential Versus Single Step Media

Infertility Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04485910
• Other study ID #: MH0004
• Status: Recruiting
• Phase: N/A
• Start date: December 1, 2019
• Est. completion date: June 1, 2021

Study information

• Verified date: June 2020
• Source: Ganin Fertility Center
• Contact: Manar M Hozyen, MSc.
• Phone: +201229483320
• Email: manarnrc[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: June 1, 2021
• Est. primary completion date: March 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 37 Years

Eligibility

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

Related Conditions & MeSH terms

• Aneuploidy
• Aneuploidy Rate
• Infertility
• Mosaicism

Intervention

Other:
• Single step media
Usage of single step media in embryo culture
• Sequential media
Usage of sequential media in embryo culture

Locations

Country	Name	City	State
Egypt	Ganin Fertility Center	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Ganin Fertility Center

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Euploidy rate	percentage of euploid embryos/ total genetic tested embryos on blast stage	5:7 days of intracytoplasmic sperm injection(ICSI)
Primary	Mosaicism rate	percentage of mosaic embryos/ total genetic tested embryos on blast stage	5:7 days of ICSI
Secondary	Fertilization rate	Percentage of fertilized oocyte (appearance of two pronuclei) / Number of injected oocytes	16:19 hours of ICSI
Secondary	Cleavage stage	Percentage of cleaved embryos/ total number of fertilized oocytes	72 hours of ICSI
Secondary	High quality of cleaved embryos	High quality D3 embryos according to Gardner's criteria / total cleaved embryos	72 hours of ICSI
Secondary	Blast formation rate	Percentage of total blastocysts / Total cleaved embryos	5:7 days of ICSI
Secondary	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