Embryo CultureNCT01706900
Incubator Temperature for Culturing Human Embryos
A study testing Incubator Temp set to 36.5 degree and Incubator Temp 37 degree in people with Embryo Culture, run by Ibn Sina Hospital at 1 site in Egypt.
Trial summary
Incubator temperature is one of the most precious variables in IVF labs. When the IVF started, almost all incubator temperatures were set at 37 degrees which mimic in vivo conditions. Some authors speculated that gametes and early embryos might need low temperatures that provide quieter metabolism. Read more about this study
- Who is it for?
- Ages 18 to 33 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Embryo Culture
- What is being tested?
- Incubator Temp set to 36.5 degree and Incubator Temp 37 degree
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 400 participants
- Where
- 1 siteEgypt
- Study dates
- Nov 2012to Dec 2015
- 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 33 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Women aged ≤ 33 years
- BMI ≤ 33
- Normal responder ( ≥ 8 MII )
- Fresh cycle
- First attempt (or with previous successful attempt)
- Normal or mild oligoasthenoteratozoospermia
Who cannot join
- Testicular sperm
- < 8 MIII collected
- Difficult transfer cycle
- endometriotic patients
- Poor Endometrium < 8mm diameter at OPU
Trial locations and contacts
1 site in 1 country.
Egypt1 site
IbnSina IVF Center, IbnSina Hospital
Sohag, Sohag Governorate, 12345
About this study
Incubator temperature is one of the most precious variables in IVF labs. When the IVF started, almost all incubator temperatures were set at 37 degrees which mimic in vivo conditions. Some authors speculated that gametes and early embryos might need low temperatures that provide quieter metabolism. We decide to compare Embryo culture at 37 degree or slightly lower 36.5 degree and extensively investigate to find which is better to crucially introduce a solid evidence through this RCT.
Read the detailed description
Since the first IVF birth in 1978, the field of assisted reproductive technology has evolved dramatically. The evolution includes both the ovarian stimulation protocols and the laboratory techniques. Optimization of the laboratory procedures is of great interest to the scientists in the field of IVF.
Incubator temperature is one of the most precious variables in IVF labs. When the IVF started, almost all incubator temperatures were set at 37 degrees which mimic in vivo conditions.
Some authors speculated that gametes and early embryos might need low temperatures that provide quieter metabolism. another group found increase in pregnancy rate for embryos cultured below 37 degree compared to those cultured at 37 degree. Nevertheless; the majority of embryologists still consider culture at 37 degrees is the back bone for the incubators.
The paucity of well designed studies makes it difficult to achieve a satisfactory answer whether lower temperature will improve the pregnancy rate. This encourage us to study the effect of lower temperature (36.5 degrees) on the pregnancy rate compared to conventional temperature (37 degrees).
- Conditions
- Embryo Culture
- Being tested
- Incubator Temp set to 36.5 degree, Incubator Temp 37 degree
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Incubator Temp set to 36.5 degreeOther
We will set incubator Temp to 36.5 so we can assess the outcome and compare the results with the placebo group.
Incubator Temp 37 degreeOther
We will set incubator Temp to 37 degree as the routine embryo culture Temp since 1978 as the placebo arm.
| Study group | Role | What they receive |
|---|---|---|
| Incubator Temp 37 degree | Placebo comparator | We will set incubator Temp to 37 degree as the routine embryo culture Temp since 1978 as the placebo arm. Receives: Other: Incubator Temp 37 degree |
| Incubator Temp set to 36.5 degree | Experimental | We will set incubator Temp to 36.5 so we can assess the outcome and compare the results with the placebo group. Receives: Other: Incubator Temp set to 36.5 degree |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fetal heart beat rate
Compare the fetal heart beat rate between the 2 study arms in the first 3 months following Embryo Transfer.
Measured: 3 months
Secondary outcomes (5)
Pregnancy rate
Measure the pregnancy rate between the 2 study arms in the following one month after Embryo Transfer
Measured: one month
Top quality embryos Day3
Measure the top quality embryos day3 between the 2 study arms in the following week after ICSI
Measured: one week
blastocyst formation rate
Measure the blastocyst formation rate between the 2 study arms in the following week after ICSI
Measured: one week
Top quality blastocyst
Measure the top quality blastocyst rate between the 2 study arms in the following week after ICSI
Measured: one week
Implantation rate
Measure the implantation rate between the 2 study arms in the following first month after Embryo Transfer
Measured: one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2012 (estimated)
- Study startNov 2012
- Primary completionDec 2015
- Study completionDec 2015
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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ibn Sina Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Muhammad Fawzy, Ibn Sina Hospital
- Investigators
- Muhammad F. Abdel-Raheem, Lab Director, Principal investigator, IbnSina IVF CenterMohamed Y. Abdel-Rahman, M.D., Principal investigator, IbnSina IVF centerHesham A. Kasem, Gynaecologist, Principal investigator, IbnSina IVF Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01706900
- Sponsor's protocol ID
- IbnSina Hospital
- Status last verified
- Jun 2016
- First submitted
- 10 Oct 2012
- Last updated
- 29 Jun 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incubator Temperature for Culturing Human Embryos
- ClinicalTrials.gov ID
- NCT01706900
- Acronym / sponsor ID
- IbnSina Hospital
- Conditions
- Embryo Culture
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- Ibn Sina HospitalOther government
- Study start
- Nov 2012
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 15 Oct 2012 (estimated)
- 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.
Incubator temperature is one of the most precious variables in IVF labs. When the IVF started, almost all incubator temperatures were set at 37 degrees which mimic in vivo conditions. Some authors speculated that gametes and early embryos might need low temperatures that provide quieter metabolism. We decide to compare Embryo culture at 37 degree or slightly lower 36.5 degree and extensively investigate to find which is better to crucially introduce a solid evidence through this RCT.
Detailed description
Since the first IVF birth in 1978, the field of assisted reproductive technology has evolved dramatically. The evolution includes both the ovarian stimulation protocols and the laboratory techniques. Optimization of the laboratory procedures is of great interest to the scientists in the field of IVF.
Incubator temperature is one of the most precious variables in IVF labs. When the IVF started, almost all incubator temperatures were set at 37 degrees which mimic in vivo conditions.
Some authors speculated that gametes and early embryos might need low temperatures that provide quieter metabolism. another group found increase in pregnancy rate for embryos cultured below 37 degree compared to those cultured at 37 degree. Nevertheless; the majority of embryologists still consider culture at 37 degrees is the back bone for the incubators.
The paucity of well designed studies makes it difficult to achieve a satisfactory answer whether lower temperature will improve the pregnancy rate. This encourage us to study the effect of lower temperature (36.5 degrees) on the pregnancy rate compared to conventional temperature (37 degrees).
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Incubator Temp 37 degree | Placebo comparator | Other: Incubator Temp 37 degreeWe will set incubator Temp to 37 degree as the routine embryo culture Temp since 1978 as the placebo arm. |
| Incubator Temp set to 36.5 degree | Experimental | Other: Incubator Temp set to 36.5 degreeWe will set incubator Temp to 36.5 so we can assess the outcome and compare the results with the placebo group. |
Who may qualify
- Ages
- 18 to 33 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Women aged ≤ 33 years
- BMI ≤ 33
- Normal responder ( ≥ 8 MII )
- Fresh cycle
- First attempt (or with previous successful attempt)
Key exclusion criteria (5 listed)
- Testicular sperm
- < 8 MIII collected
- Difficult transfer cycle
- endometriotic patients
- Poor Endometrium < 8mm diameter at OPU
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 |
|---|---|---|
| Incubator Temp set to 36.5 degreeWe will set incubator Temp to 36.5 so we can assess the outcome and compare the results with the placebo group. | Other | Incubator Temp set to 36.5 degree |
| Incubator Temp 37 degreeWe will set incubator Temp to 37 degree as the routine embryo culture Temp since 1978 as the placebo arm. | Other | Incubator Temp 37 degree |
Primary outcome
Fetal heart beat rate
Time frame: 3 months
Compare the fetal heart beat rate between the 2 study arms in the first 3 months following Embryo Transfer.
5 secondary outcomes
Pregnancy rate
Time frame: one month
Top quality embryos Day3
Time frame: one week
blastocyst formation rate
Time frame: one week
Top quality blastocyst
Time frame: one week
Implantation rate
Time frame: one month
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 29 Jun 2016.
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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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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.
Muhammad F. Abdel-Raheem, Lab Director principal investigator
IbnSina IVF Center
Mohamed Y. Abdel-Rahman, M.D. principal investigator
IbnSina IVF center
Hesham A. Kasem, Gynaecologist principal investigator
IbnSina IVF Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Incubator Temp set to 36.5 degree and Incubator Temp 37 degree in people with Embryo Culture, run by Ibn Sina Hospital at 1 site 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 6 inclusion and 5 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 29 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. Some participants in this study may receive a placebo. 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?
Fetal heart beat rate (time frame: 3 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 29 Jun 2016.