PGTai Results for Embryos Cultured in Sequential Versus Single Step Media

July 22, 2020 updated by: Ganin Fertility Center

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Amr Elshimy, BSc.

Study Locations

  • Egypt
      • Cairo, Egypt, 11728
        • Recruiting
        • Ganin Fertility Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 37 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Single step media
Embryos cultured in single step media
Other: Single step media
Usage of single step media in embryo culture
ACTIVE_COMPARATOR: Sequential media
Embryos cultured in sequential media
Other: Sequential media
Usage of sequential media in embryo culture

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ganin Fertility Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

December 1, 2019

Primary Completion (ANTICIPATED)

March 1, 2021

Study Completion (ANTICIPATED)

June 1, 2021

Study Registration Dates

First Submitted

July 22, 2020

First Submitted That Met QC Criteria

July 22, 2020

First Posted (ACTUAL)

July 24, 2020

Study Record Updates

Last Update Posted (ACTUAL)

July 24, 2020

Last Update Submitted That Met QC Criteria

July 22, 2020

Last Verified

June 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MH0004

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Infertility

Clinical Trials on Single step media

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Hungary

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe