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

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

Detailed Description
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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

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

Conditions
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Embryonic Development, Infertility

Intervention / Treatment
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* Other: GPS/LM
* Other: SPL/LM
* Other: GPS/PO
* Other: SPL/PO


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 37 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: GPS / LM versus SPL/LM<br>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<br>* Media microdroplet geometry (3D dishes) in combination with light mineral oil overlay<br>Other: SPL/LM<br>* Media microdroplet geometry (2D dishes) in combination with light mineral oil overlay<br>|
| Other: GPS/PO versus SPL/PO<br>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<br>* Media microdroplet geometry (3D dishes) in combination with Paraffin oil overlay<br>Other: SPL/PO<br>* Media microdroplet geometry (2D dishes) in combination with paraffin oil overlay<br>|
| Other: GPS/PO versus GPS/LM<br>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<br>* Media microdroplet geometry (3D dishes) in combination with light mineral oil overlay<br>Other: GPS/PO<br>* Media microdroplet geometry (3D dishes) in combination with Paraffin oil overlay<br>|
| Other: SPL/PO versus SPL/LM<br>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<br>* Media microdroplet geometry (2D dishes) in combination with light mineral oil overlay<br>Other: SPL/PO<br>* Media microdroplet geometry (2D dishes) in combination with paraffin oil overlay<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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dry incubator, Osmolality, Oil overlay, Microdrops