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

NCT ID: NCT04485806

Last Updated: 2020-07-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-08-01

Study Completion Date

2020-01-10

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Embryonic Development Infertility

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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).

Group Type OTHER

GPS/LM

Intervention Type OTHER

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

SPL/LM

Intervention Type OTHER

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

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).

Group Type OTHER

GPS/PO

Intervention Type OTHER

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

SPL/PO

Intervention Type OTHER

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

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).

Group Type OTHER

GPS/LM

Intervention Type OTHER

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

GPS/PO

Intervention Type OTHER

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

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).

Group Type OTHER

SPL/LM

Intervention Type OTHER

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

SPL/PO

Intervention Type OTHER

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

GPS/LM

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

Intervention Type OTHER

SPL/LM

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

Intervention Type OTHER

GPS/PO

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

Intervention Type OTHER

SPL/PO

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

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

37 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Ganin Fertility Center

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Manar M Hozyen, MSc.

Role: PRINCIPAL_INVESTIGATOR

Ganin Fertility Center

Amr Elshimy, BSc.

Role: PRINCIPAL_INVESTIGATOR

Ganin Fertility Center

Hanaa Elkhader, BSc.

Role: PRINCIPAL_INVESTIGATOR

Ganin Fertility Center

Hosam Zaki, MSc.

Role: STUDY_CHAIR

Ganin Fertility Center

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Ganin Fertility Center

Cairo, , Egypt

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Egypt

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

MH0002

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.