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Completed

NCT Number: NCT04485806

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

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

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Key information

Conditions

Embryonic Development Genital Diseases Infertility Urogenital Diseases

Age range

18 year–37 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Ganin Fertility Center

Cairo, 11728, Egypt

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

GPS/LM

Other

Media microdroplet geometry (3D dishes) in combination with light mineral oil overlay

SPL/LM

Other

Media microdroplet geometry (2D dishes) in combination with light mineral oil overlay

GPS/PO

Other

Media microdroplet geometry (3D dishes) in combination with Paraffin oil overlay

SPL/PO

Other

Media microdroplet geometry (2D dishes) in combination with paraffin oil overlay

Primary outcomes

  1. Blastulation rate

    Time frame: 5-6 days after ICSI

    Percentage of total blastocysts / Total cleaved embryos

  2. High quality blast rate

    Time frame: 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 outcomes

  1. Fertilization rate

    Time frame: 16-19 hours of ICSI

    Percentage of fertilized oocyte (appearance of two pronuclei) / Number of injected oocytes

  2. Cleavage rate

    Time frame: 72 hours of ICSI

    Percentage of cleaved embryos/ total number of fertilized oocytes

  3. High quality D3 embryos

    Time frame: 72 hours of ICSI

    High quality D3 embryos according to Gardner's criteria / total cleaved embryos

  4. Good quality trophectoderm/inner cell mass

    Time frame: 5-6 days after ICSI

    better grade than 3BB of blast embryos according to Gardner's criteria 1999

Sponsors and collaborators

Lead sponsor

Ganin Fertility Center

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Jul 24, 2020
Registry last updated
Jul 24, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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