Embryo CultureNCT03630900
Sequential Versus Single O2 Levels on Human Embryo Development
A study testing Sequential O2 Culture in people with Embryo Culture, run by Ibn Sina Hospital at 3 sites in Egypt.
Trial summary
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%. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Embryo Culture
- What is being tested?
- Sequential O2 Culture
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 487 participants
- Where
- 3 sitesEgypt
- Study dates
- 24 Aug 2018to 1 Jul 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- ICSI cycles undergoing their first ICSI attempt
Who cannot join
- ICSI cycles with a previous failure
Trial locations and contacts
3 sites in 1 country.
Egypt3 sites
Banon Assiut
Asyut
Qena Fertility Center
Qina, Qena Governorate, 123456
IbnSina IVF Center
Sohag
About this study
Official title: 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.
- Conditions
- Embryo Culture
- Being tested
- Sequential O2 Culture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sequential O2 CultureOther
We investigate the effect of sequential O2 levels on human embryo culture after Intracytoplasmic sperm injection (ICSI)
| Study group | Role | What they receive |
|---|---|---|
| Sequential O2 culture (5% then 2.5%) | Experimental | Embryo culture from day 0 to 3 in 5% O2 then split to either 5% or 2.5% O2 until Day 5 or 6. Receives: Other: Sequential O2 Culture |
| 5% O2 culture | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ongoing Implantation rate
number of sacs with a heartbeat after week twelve of gestation
Measured: three months
Secondary outcomes (2)
clinical and ongoing pregnancies
registered pregnancy with fetal heartbeat at week four after transfer and after week twelve of gestation
Measured: three months
human embryo development in vitro
Measured: three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2018
- Study start24 Aug 2018
- Primary completion20 Jun 2019
- Study completion1 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Embryo CultureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 487 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ibn Sina Hospital
- Sponsor type
- Other government
- Collaborators
- Banoon IVF Center
- Responsible party
- Principal investigator, Muhammad Fawzy, Ibn Sina Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03630900
- Sponsor's protocol ID
- Ibnsina IVF-Oxygen
- Status last verified
- Jul 2019
- First submitted
- 10 Aug 2018
- Last updated
- 16 Jul 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 5% O2 or Lower is the Ideal Tension for Culturing Human Embryo Development From Day 3 Onward
- ClinicalTrials.gov ID
- NCT03630900
- Acronym / sponsor ID
- Ibnsina IVF-Oxygen
- Conditions
- Embryo Culture
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 487 participants (actual)
- Lead sponsor
- Ibn Sina HospitalOther government
- Collaborators
- Banoon IVF Center
- Study start
- 24 Aug 2018 (actual)
- Primary completion
- 20 Jun 2019 (actual)
- Study completion
- 1 Jul 2019 (actual)
- First posted
- 15 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sequential O2 culture (5% then 2.5%) | Experimental | Other: Sequential O2 CultureEmbryo culture from day 0 to 3 in 5% O2 then split to either 5% or 2.5% O2 until Day 5 or 6. |
| 5% O2 culture | No intervention | – |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- ICSI cycles undergoing their first ICSI attempt
Key exclusion criteria (1 listed)
- ICSI cycles with a previous failure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sequential O2 CultureWe investigate the effect of sequential O2 levels on human embryo culture after Intracytoplasmic sperm injection (ICSI) | Other | Sequential O2 culture (5% then 2.5%) |
Primary outcome
Ongoing Implantation rate
Time frame: three months
number of sacs with a heartbeat after week twelve of gestation
2 secondary outcomes
clinical and ongoing pregnancies
Time frame: three months
human embryo development in vitro
Time frame: three months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2019.
- Individual participant dataSharing planned: No
Related trials for Embryo Culture
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RecruitingObservational study
Study of Abnormally Fertilized Embryos
Infertility (IVF Patients)
Recruiting
A Multicenter Prospective Randomized Controlled Clinical Trial Comparing Constant (5%) Versus Sequential (5%-2%) Oxygen Concentration Embryo Culture Protocols in Assisted Reproductive Technology
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Not yet recruiting
OSC Co-culture for Rescue IVM of Human GV Oocytes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sequential O2 Culture in people with Embryo Culture, run by Ibn Sina Hospital at 3 sites in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ongoing Implantation rate (time frame: three months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2019.