Sequential Versus Single O2 Levels on Human Embryo Development

NCT ID: NCT03630900

Last Updated: 2019-07-16

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

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

487 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-08-24

Study Completion Date

2019-07-01

Brief Summary

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Myriads of elements affect human embryo culture in vitro. These include, but not limited to, air quality, culture media, culture temperature, incubator humidity, pH, and O2 levels. O2 tension has been thoroughly investigated and, to date, 5% O2 level is superior to 20%. Reports showed that lowering the O2 from Day 3 of embryo culture seems to be physiological.

Detailed Description

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Conditions

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Embryo Culture

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Sequential O2 culture (5% then 2.5%)

Embryo culture from day 0 to 3 in 5% O2 then split to either 5% or 2.5% O2 until Day 5 or 6.

Group Type EXPERIMENTAL

Sequential O2 Culture

Intervention Type OTHER

We investigate the effect of sequential O2 levels on human embryo culture after Intracytoplasmic sperm injection (ICSI)

5% O2 culture

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Sequential O2 Culture

We investigate the effect of sequential O2 levels on human embryo culture after Intracytoplasmic sperm injection (ICSI)

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* ICSI cycles undergoing their first ICSI attempt

Exclusion Criteria

* ICSI cycles with a previous failure
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Banoon IVF Center

OTHER

Sponsor Role collaborator

Ibn Sina Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Muhammad Fawzy

IVF Lab Director

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Qena Fertility Center

Qina, Qena Governorate, Egypt

Site Status

Banon Assiut

Asyut, , Egypt

Site Status

IbnSina IVF Center

Sohag, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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Ibnsina IVF-Oxygen

Identifier Type: -

Identifier Source: org_study_id

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