NCT04485806

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2019

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2020

Completed
9 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 10, 2020

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

July 22, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 24, 2020

Completed
Last Updated

July 24, 2020

Status Verified

July 1, 2020

Enrollment Period

5 months

First QC Date

July 22, 2020

Last Update Submit

July 22, 2020

Conditions

Embryonic DevelopmentInfertility

Keywords

dry incubatorOsmolalityOil overlayMicrodrops

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (4)

  • Fertilization rate

    16-19 hours of ICSI

  • Cleavage rate

    72 hours of ICSI

  • High quality D3 embryos

    72 hours of ICSI

  • Good quality trophectoderm/inner cell mass

    5-6 days after ICSI

Study Arms (4)

GPS / LM versus SPL/LM

OTHER

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/LMOther: SPL/LM

GPS/PO versus SPL/PO

OTHER

to determine the effect of micro droplet geometry in 3D dishes (GPS) or 2D dishes (SPL) in combination with paraffin oil (PO).

Other: GPS/POOther: SPL/PO

GPS/PO versus GPS/LM

OTHER

to determine the effect of oil overlay light mineral(LM) or paraffin oil (PO) in combination with paraffin oil 3D dishes (GPS).

Other: GPS/LMOther: GPS/PO

SPL/PO versus SPL/LM

OTHER

to determine the effect of oil overlay light mineral(LM) or paraffin oil (PO) in combination with paraffin oil 2D dishes (SPL).

Other: SPL/LMOther: SPL/PO

Interventions

GPS/LMOTHER

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

GPS / LM versus SPL/LMGPS/PO versus GPS/LM
SPL/LMOTHER

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

GPS / LM versus SPL/LMSPL/PO versus SPL/LM
GPS/POOTHER

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

GPS/PO versus GPS/LMGPS/PO versus SPL/PO
SPL/POOTHER

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

GPS/PO versus SPL/POSPL/PO versus SPL/LM

Eligibility Criteria

Age18 Years - 37 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • Oocyte or sperm donation.
  • Sever male factor.
  • Any contradictions to undergoing in vitro fertilization or goandotropin stimulation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ganin Fertility Center

Cairo, 11728, Egypt

Location

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Study Officials

  • Manar M Hozyen, MSc.

    Ganin Fertility Center

    PRINCIPAL INVESTIGATOR

  • Amr Elshimy, BSc.

    Ganin Fertility Center

    PRINCIPAL INVESTIGATOR

  • Hanaa Elkhader, BSc.

    Ganin Fertility Center

    PRINCIPAL INVESTIGATOR

  • Hosam Zaki, MSc.

    Ganin Fertility Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 22, 2020

First Posted

July 24, 2020

Study Start

August 1, 2019

Primary Completion

January 1, 2020

Study Completion

January 10, 2020

Last Updated

July 24, 2020

Record last verified: 2020-07

Locations

EG(1)