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

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

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

Study Overview

• Status: Completed
• Conditions: Infertility; Embryonic Development
• Intervention / Treatment: Other: GPS/LM; Other: SPL/LM; Other: GPS/PO; Other: SPL/PO

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 Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 37 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blastulation rate	Percentage of total blastocysts / Total cleaved embryos	5-6 days after ICSI
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.	5-6 days after ICSI

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Ganin Fertility Center

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2019
• Primary Completion (Actual): January 1, 2020
• Study Completion (Actual): January 10, 2020

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: July 1, 2020

More Information

Terms related to this study

• Keywords: Osmolality; dry incubator; Oil overlay; Microdrops
• Additional Relevant MeSH Terms: Infertility
• Other Study ID Numbers: MH0002

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No