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PGTai Results for Embryos Cultured in Sequential Versus Single Step Media

Primary Purpose

Infertility, Aneuploidy Rate, Mosaicism

Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Single step media
Sequential media
Sponsored by
Ganin Fertility Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Infertility focused on measuring PGT-A, Mosaicism, Single step media, Sequential media

Eligibility Criteria

18 Years - 37 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Ganin Fertility CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Single step media

Sequential media

Arm Description

Embryos cultured in single step media

Embryos cultured in sequential media

Outcomes

Primary Outcome Measures

Euploidy rate
percentage of euploid embryos/ total genetic tested embryos on blast stage
Mosaicism rate
percentage of mosaic embryos/ total genetic tested embryos on blast stage

Secondary Outcome Measures

Fertilization rate
Percentage of fertilized oocyte (appearance of two pronuclei) / Number of injected oocytes
Cleavage stage
Percentage of cleaved embryos/ total number of fertilized oocytes
High quality of cleaved embryos
High quality D3 embryos according to Gardner's criteria / total cleaved embryos
Blast formation rate
Percentage of total blastocysts / Total cleaved embryos
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.

Full Information

First Posted
July 22, 2020
Last Updated
July 22, 2020
Sponsor
Ganin Fertility Center
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1. Study Identification

Unique Protocol Identification Number
NCT04485910
Brief Title
PGTai Results for Embryos Cultured in Sequential Versus Single Step Media
Official Title
Sequential Versus Single Step Culture Media in Relation to Euploidy Rates in PGTai Program
Study Type
Interventional

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Unknown status
Study Start Date
December 1, 2019 (Actual)
Primary Completion Date
March 1, 2021 (Anticipated)
Study Completion Date
June 1, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ganin Fertility Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility, Aneuploidy Rate, Mosaicism
Keywords
PGT-A, Mosaicism, Single step media, Sequential media

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Evaluating the embryonic development and PGTai results for embryos cultured in sequential media versus single step media.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Single step media
Arm Type
Active Comparator
Arm Description
Embryos cultured in single step media
Arm Title
Sequential media
Arm Type
Active Comparator
Arm Description
Embryos cultured in sequential media
Intervention Type
Other
Intervention Name(s)
Single step media
Intervention Description
Usage of single step media in embryo culture
Intervention Type
Other
Intervention Name(s)
Sequential media
Intervention Description
Usage of sequential media in embryo culture
Primary Outcome Measure Information:
Title
Euploidy rate
Description
percentage of euploid embryos/ total genetic tested embryos on blast stage
Time Frame
5:7 days of intracytoplasmic sperm injection(ICSI)
Title
Mosaicism rate
Description
percentage of mosaic embryos/ total genetic tested embryos on blast stage
Time Frame
5:7 days of ICSI
Secondary Outcome Measure Information:
Title
Fertilization rate
Description
Percentage of fertilized oocyte (appearance of two pronuclei) / Number of injected oocytes
Time Frame
16:19 hours of ICSI
Title
Cleavage stage
Description
Percentage of cleaved embryos/ total number of fertilized oocytes
Time Frame
72 hours of ICSI
Title
High quality of cleaved embryos
Description
High quality D3 embryos according to Gardner's criteria / total cleaved embryos
Time Frame
72 hours of ICSI
Title
Blast formation rate
Description
Percentage of total blastocysts / Total cleaved embryos
Time Frame
5:7 days of ICSI
Title
High quality blast rate
Description
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.
Time Frame
5:7 days of ICSI

10. Eligibility

Sex
All
Gender Based
Yes
Gender Eligibility Description
Female age ≤37 years with ≥ 8 mature oocytes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
37 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Manar M Hozyen, MSc.
Phone
+201229483320
Email
manarnrc@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Amr Elshimy, BSc.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Manar M Hozyen, MSc.
Organizational Affiliation
Ganin Fertility Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Amr Elshimy, BSc.
Organizational Affiliation
Ganin Fertility Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Hanaa Elkhader, BSc.
Organizational Affiliation
Ganin Fertility Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Hosam Zaki, MSc.
Organizational Affiliation
Ganin Fertility Center
Official's Role
Study Chair
Facility Information:
Facility Name
Ganin Fertility Center
City
Cairo
ZIP/Postal Code
11728
Country
Egypt
Individual Site Status
Recruiting

12. IPD Sharing Statement

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PGTai Results for Embryos Cultured in Sequential Versus Single Step Media

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