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

Infertility Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04485806
• Other study ID #: MH0002
• Status: Completed
• Phase: N/A
• Start date: August 1, 2019
• Est. completion date: January 10, 2020

Study information

• Verified date: July 2020
• Source: Ganin Fertility Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: January 10, 2020
• Est. primary completion date: January 1, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 37 Years

Eligibility

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.

Related Conditions & MeSH terms

• Embryonic Development
• Infertility

Intervention

Other:
• GPS/LM
Media microdroplet geometry (3D dishes) in combination with light mineral oil overlay
• SPL/LM
Media microdroplet geometry (2D dishes) in combination with light mineral oil overlay
• GPS/PO
Media microdroplet geometry (3D dishes) in combination with Paraffin oil overlay
• SPL/PO
Media microdroplet geometry (2D dishes) in combination with paraffin oil overlay

Locations

Country	Name	City	State
Egypt	Ganin Fertility Center	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Ganin Fertility Center

Country where clinical trial is conducted

Egypt, 

Outcome

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