- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03630900
Sequential Versus Single O2 Levels on Human Embryo Development
July 14, 2019 updated by: Muhammad Fawzy, Ibn Sina Hospital
5% O2 or Lower is the Ideal Tension for Culturing Human Embryo Development From Day 3 Onward
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.
Study Overview
Study Type
Interventional
Enrollment (Actual)
487
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Assiut, Egypt
- Banon Assiut
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Qena, Egypt, 123456
- Qena Fertility Center
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Sohag, Egypt
- IbnSina IVF Center
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 40 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- ICSI cycles undergoing their first ICSI attempt
Exclusion Criteria:
- ICSI cycles with a previous failure
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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.
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We investigate the effect of sequential O2 levels on human embryo culture after Intracytoplasmic sperm injection (ICSI)
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No Intervention: 5% O2 culture
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Ongoing Implantation rate
Time Frame: three months
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number of sacs with a heartbeat after week twelve of gestation
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three months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
clinical and ongoing pregnancies
Time Frame: three months
|
registered pregnancy with fetal heartbeat at week four after transfer and after week twelve of gestation
|
three months
|
human embryo development in vitro
Time Frame: three months
|
three months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 24, 2018
Primary Completion (Actual)
June 20, 2019
Study Completion (Actual)
July 1, 2019
Study Registration Dates
First Submitted
August 10, 2018
First Submitted That Met QC Criteria
August 10, 2018
First Posted (Actual)
August 15, 2018
Study Record Updates
Last Update Posted (Actual)
July 16, 2019
Last Update Submitted That Met QC Criteria
July 14, 2019
Last Verified
July 1, 2019
More Information
Terms related to this study
Other Study ID Numbers
- Ibnsina IVF-Oxygen
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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