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

Sponsor

Ganin Fertility Center (Other)

Overall Status

Completed

CT.gov ID

NCT04485806

Collaborator

(none)

100

Enrollment

Location

Arms

5.3

Actual Duration (Months)

18.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

A prospective randomized study included 1695 MII sibling oocytes collected from 100 patients undergoing ICSI.

Condition or Disease	Intervention/Treatment	Phase
Embryonic Development Infertility	Other: GPS/LM Other: SPL/LM Other: GPS/PO Other: SPL/PO	N/A

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

Study Design

Study Type:

Interventional

Actual Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention 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.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)

Primary Purpose:

Other

Official Title:

The Effect of Culture Media Microdroplet Geometry and Different Oil Overlay on Pre Implantation Embryonic Development in Dry Incubators: Prospective Randomized Study.

Actual Study Start Date :

Aug 1, 2019

Actual Primary Completion Date :

Jan 1, 2020

Actual Study Completion Date :

Jan 10, 2020

Arms and Interventions

Arm	Intervention/Treatment
Other: GPS / LM versus SPL/LM to determine the effect of micro droplet geometry in 3D dishes (GPS) or 2D dishes (SPL) in combination with light mineral oil (LM).	Other: GPS/LM Media microdroplet geometry (3D dishes) in combination with light mineral oil overlay Other: SPL/LM Media microdroplet geometry (2D dishes) in combination with light mineral oil overlay
Other: GPS/PO versus SPL/PO to determine the effect of micro droplet geometry in 3D dishes (GPS) or 2D dishes (SPL) in combination with paraffin oil (PO).	Other: GPS/PO Media microdroplet geometry (3D dishes) in combination with Paraffin oil overlay Other: SPL/PO Media microdroplet geometry (2D dishes) in combination with paraffin oil overlay
Other: GPS/PO versus GPS/LM to determine the effect of oil overlay light mineral(LM) or paraffin oil (PO) in combination with paraffin oil 3D dishes (GPS).	Other: GPS/LM Media microdroplet geometry (3D dishes) in combination with light mineral oil overlay Other: GPS/PO Media microdroplet geometry (3D dishes) in combination with Paraffin oil overlay
Other: SPL/PO versus SPL/LM to determine the effect of oil overlay light mineral(LM) or paraffin oil (PO) in combination with paraffin oil 2D dishes (SPL).	Other: SPL/LM Media microdroplet geometry (2D dishes) in combination with light mineral oil overlay Other: SPL/PO Media microdroplet geometry (2D dishes) in combination with paraffin oil overlay

Outcome Measures

Primary Outcome Measures

Blastulation rate [5-6 days after ICSI]
Percentage of total blastocysts / Total cleaved embryos
High quality blast rate [5-6 days after 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.

Secondary Outcome Measures

Fertilization rate [16-19 hours of ICSI]
Percentage of fertilized oocyte (appearance of two pronuclei) / Number of injected oocytes
Cleavage rate [72 hours of ICSI]
Percentage of cleaved embryos/ total number of fertilized oocytes
High quality D3 embryos [72 hours of ICSI]
High quality D3 embryos according to Gardner's criteria / total cleaved embryos
Good quality trophectoderm/inner cell mass [5-6 days after ICSI]
better grade than 3BB of blast embryos according to Gardner's criteria 1999

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 37 Years

Sexes Eligible for Study:

Female

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ganin Fertility Center	Cairo		Egypt	11728

Sponsors and Collaborators

Ganin Fertility Center

Investigators

Principal Investigator: Manar M Hozyen, MSc., Ganin Fertility Center
Principal Investigator: Amr Elshimy, BSc., Ganin Fertility Center
Principal Investigator: Hanaa Elkhader, BSc., Ganin Fertility Center
Study Chair: Hosam Zaki, MSc., Ganin Fertility Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Ganin Fertility Center

ClinicalTrials.gov Identifier:

NCT04485806

Other Study ID Numbers:

MH0002

First Posted:

Jul 24, 2020

Last Update Posted:

Jul 24, 2020

Last Verified:

Jul 1, 2020

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Ganin Fertility Center

Additional relevant MeSH terms:

Infertility

Study Results

No Results Posted as of Jul 24, 2020