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Culture Media Microdroplet Geometry With Different Oil Overlay and Its Effect on Embryonic Development.

Primary Purpose

Embryonic Development, Infertility

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
GPS/LM
SPL/LM
GPS/PO
SPL/PO
Sponsored by
Ganin Fertility Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Embryonic Development focused on measuring dry incubator, Osmolality, Oil overlay, Microdrops

Eligibility Criteria

18 Years - 37 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Female age is ≤ 37 years old with ≥ 8 MII oocytes
  • Males with normal semen parameters (WHO 2010).
  • We conducted three experiments all with Siblings oocytes splits and all embryos

Exclusion Criteria:

  • Oocyte or sperm donation.
  • Sever male factor.
  • Any contradictions to undergoing in vitro fertilization or goandotropin stimulation.

Sites / Locations

  • Ganin Fertility Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Other

Other

Other

Other

Arm Label

GPS / LM versus SPL/LM

GPS/PO versus SPL/PO

GPS/PO versus GPS/LM

SPL/PO versus SPL/LM

Arm Description

to determine the effect of micro droplet geometry in 3D dishes (GPS) or 2D dishes (SPL) in combination with light mineral oil (LM).

to determine the effect of micro droplet geometry in 3D dishes (GPS) or 2D dishes (SPL) in combination with paraffin oil (PO).

to determine the effect of oil overlay light mineral(LM) or paraffin oil (PO) in combination with paraffin oil 3D dishes (GPS).

to determine the effect of oil overlay light mineral(LM) or paraffin oil (PO) in combination with paraffin oil 2D dishes (SPL).

Outcomes

Primary Outcome Measures

Blastulation 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.

Secondary Outcome Measures

Fertilization rate
Percentage of fertilized oocyte (appearance of two pronuclei) / Number of injected oocytes
Cleavage rate
Percentage of cleaved embryos/ total number of fertilized oocytes
High quality D3 embryos
High quality D3 embryos according to Gardner's criteria / total cleaved embryos
Good quality trophectoderm/inner cell mass
better grade than 3BB of blast embryos according to Gardner's criteria 1999

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
NCT04485806
Brief Title
Culture Media Microdroplet Geometry With Different Oil Overlay and Its Effect on Embryonic Development.
Official Title
The Effect of Culture Media Microdroplet Geometry and Different Oil Overlay on Pre Implantation Embryonic Development in Dry Incubators: Prospective Randomized Study.
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
August 1, 2019 (Actual)
Primary Completion Date
January 1, 2020 (Actual)
Study Completion Date
January 10, 2020 (Actual)

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 randomized study included 1695 MII sibling oocytes collected from 100 patients undergoing ICSI.
Detailed Description
Purpose: to determine the effect of culture media microdroplet geometry of different culture dishes and oil overlay on the pre implantation embryo development in dry incubators Method: We used sibling oocytes splits between two different dishes : GPS (life global, USA) and SPL (life science, Korea) with two different oils : light mineral oil (LM)(Irvine, USA) and paraffin oil (PO)(Vitro life, Sweden). All embryos cultured in dry incubators at the same conditions. statistical analysis done using SPSS version 23

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Embryonic Development, Infertility
Keywords
dry incubator, Osmolality, Oil overlay, Microdrops

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Effect of two different culture dishes with two different oil overlay which used in human embryos culturing through ICSI procedures on the pre implantaion embryonic development.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
GPS / LM versus SPL/LM
Arm Type
Other
Arm Description
to determine the effect of micro droplet geometry in 3D dishes (GPS) or 2D dishes (SPL) in combination with light mineral oil (LM).
Arm Title
GPS/PO versus SPL/PO
Arm Type
Other
Arm Description
to determine the effect of micro droplet geometry in 3D dishes (GPS) or 2D dishes (SPL) in combination with paraffin oil (PO).
Arm Title
GPS/PO versus GPS/LM
Arm Type
Other
Arm Description
to determine the effect of oil overlay light mineral(LM) or paraffin oil (PO) in combination with paraffin oil 3D dishes (GPS).
Arm Title
SPL/PO versus SPL/LM
Arm Type
Other
Arm Description
to determine the effect of oil overlay light mineral(LM) or paraffin oil (PO) in combination with paraffin oil 2D dishes (SPL).
Intervention Type
Other
Intervention Name(s)
GPS/LM
Intervention Description
Media microdroplet geometry (3D dishes) in combination with light mineral oil overlay
Intervention Type
Other
Intervention Name(s)
SPL/LM
Intervention Description
Media microdroplet geometry (2D dishes) in combination with light mineral oil overlay
Intervention Type
Other
Intervention Name(s)
GPS/PO
Intervention Description
Media microdroplet geometry (3D dishes) in combination with Paraffin oil overlay
Intervention Type
Other
Intervention Name(s)
SPL/PO
Intervention Description
Media microdroplet geometry (2D dishes) in combination with paraffin oil overlay
Primary Outcome Measure Information:
Title
Blastulation rate
Description
Percentage of total blastocysts / Total cleaved embryos
Time Frame
5-6 days after 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
5-6 days after 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 rate
Description
Percentage of cleaved embryos/ total number of fertilized oocytes
Time Frame
72 hours of ICSI
Title
High quality D3 embryos
Description
High quality D3 embryos according to Gardner's criteria / total cleaved embryos
Time Frame
72 hours of ICSI
Title
Good quality trophectoderm/inner cell mass
Description
better grade than 3BB of blast embryos according to Gardner's criteria 1999
Time Frame
5-6 days after ICSI

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
37 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Female age is ≤ 37 years old with ≥ 8 MII oocytes Males with normal semen parameters (WHO 2010). We conducted three experiments all with Siblings oocytes splits and all embryos Exclusion Criteria: Oocyte or sperm donation. Sever male factor. Any contradictions to undergoing in vitro fertilization or goandotropin stimulation.
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

12. IPD Sharing Statement

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Culture Media Microdroplet Geometry With Different Oil Overlay and Its Effect on Embryonic Development.

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