Ongoing Pregnancy RateNCT01695096
High Versus Free Humidity Incubators; A Randomized Clinical Trial
A study testing The Embryos will be cultured on a humidity free incubator and The Embryos will be cultured on a >95% humidity incubator in people with Ongoing Pregnancy Rate, run by Ibn Sina Hospital at 2 sites in Egypt.
Trial summary
To compare Top quality embryos either day3 or day 5, Pregnancy rate and most importantly ongoing pregnancy rate between high humidity incubators and humidity free incubators 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
- Ongoing Pregnancy Rate
- What is being tested?
- The Embryos will be cultured on a humidity free incubator and The Embryos will be cultured on a >95% humidity incubator
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 284 participants
- Where
- 2 sitesEgypt
- Study dates
- Oct 2012to Oct 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
- < 33 years, BMI<30,
- Normo Responder(>8 MII)
- Fresh Cycle
- Ist attempt
- Normal or mild oligoasthenoteratozoospermia.
Who cannot join
- Testicular sperm
- < 8 MII collected
- difficult transfer cycle
- Endometriotic patients
- Poor Endometrium < 8mm diameter at Ovum Pickup
- any other medical diseases
Trial locations and contacts
2 sites in 1 country.
Egypt2 sites
Gannah IVF unit, Gannah Hospital
Giza, Giza Governorate, 12345
IbnSina IVF unit, IbnSina Hospital, El Areef Square
Sohag, Sohag Governorate, 12345
About this study
To compare Top quality embryos either day3 or day 5, Pregnancy rate and most importantly ongoing pregnancy rate between high humidity incubators and humidity free incubators
Read the detailed description
When the IVF started the majority of incubators designed to support high humidity because the designers and IVF specialists believed that the humidity will maintain stable ph and Temp.
Recent reports suggest that humidity is recommended and the others suggest no difference So we decide to go for this RCT. Nevertheless; high humidity is maintained in vivo (uterus and fallopian tubes) due to the fluid content and stable body temperatures at 37°C. David McCulloch reported 15% reduction of the miscarriage rate after changing the humidity from 76% to 100% (Textbook of Assisted Reproductive Techniques: Laboratory Perspectives, Fourth Edition). Some embryologists claim that the humidity free incubators may increase the chance of chemical pregnancy and early fetal loss (Private center IbnSina IVF, Sohag, Egypt. unpublished data). This observations are never tested in a well designed randomized clinical trial (RCT) to eliminate the probability of chance and to reach a solid evidence.
The question that should be asked : is high humidity culture should be applied or there is no difference between dry and high humidity culture conditions?
- Conditions
- Ongoing Pregnancy Rate
- Being tested
- The Embryos will be cultured on a humidity free incubator, The Embryos will be cultured on a >95% humidity incubator
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The Embryos will be cultured on a humidity free incubatorOther
We will set the humidity level to 0.0% in the IVF incubator that will be used for culturing the Human embryos after ICSI procedure and we will monitor the outcome embryologically and clinically and record the results.
The Embryos will be cultured on a >95% humidity incubatorOther
We will set the humidity level to 95% in the IVF incubator that will be used for culturing the Human embryos after ICSI procedure and we will monitor the outcome embryologically and clinically and record the results.
| Study group | Role | What they receive |
|---|---|---|
| The Embryos will be cultured on a humidity free incubator | Experimental | We will set the humidity level to 0.0% in the IVF incubator that will be used for culturing the Human embryos after ICSI procedure and we will monitor the outcome embryologically and clinically and record the results. Receives: Other: The Embryos will be cultured on a humidity free incubator |
| The Embryos will be cultured on a >95% humidity incubator | Placebo comparator | We will set the humidity level to > 95% in the IVF incubator that will be used for culturing the Human embryos after ICSI procedure and we will monitor the outcome embryologically and clinically and record the results. Receives: Other: The Embryos will be cultured on a >95% humidity incubator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ongoing pregnancy rate
assessing the ongoing pregnancy rate and its difference between the 2 study arms.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2012 (estimated)
- Study startOct 2012
- Primary completionOct 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ongoing Pregnancy RateStudies 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
- 284 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ibn Sina Hospital
- Sponsor type
- Other government
- Collaborators
- Ganna Hospital
- Responsible party
- Principal investigator, Muhammad Fawzy, Ibn Sina Hospital
- Investigators
- Muhammad F. Abdel-Raheem, Lab Director, Principal investigator, IBNSINA IVF CenterMuhammad El Hady, Lab Director, Principal investigator, Ganna HospitalMohamed Y. Abdel-Rahman, M.D., Study director, IBNSINA IVF center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01695096
- Sponsor's protocol ID
- ibnsinaH
- Other IDs
- ibnsinaH
- Status last verified
- Jun 2016
- First submitted
- 24 Sep 2012
- Last updated
- 29 Jun 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Fawzy M, AbdelRahman MY, Zidan MH, Abdel Hafez FF, Abdelghafar H, Al-Inany H, Bedaiwy MA. Humid versus dry incubator: a prospective, randomized, controlled trial. Fertil Steril. 2017 Aug;108(2):277-283. doi: 10.1016/j.fertnstert.2017.05.036. Epub 2017 Jun 23.
PubMed 28651960
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
- High Versus Free Humidity Incubators; A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT01695096
- Acronym / sponsor ID
- ibnsinaH
- Conditions
- Ongoing Pregnancy Rate
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 284 participants (actual)
- Lead sponsor
- Ibn Sina HospitalOther government
- Collaborators
- Ganna Hospital
- Study start
- Oct 2012
- Primary completion
- Oct 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 27 Sep 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.
To compare Top quality embryos either day3 or day 5, Pregnancy rate and most importantly ongoing pregnancy rate between high humidity incubators and humidity free incubators
Detailed description
When the IVF started the majority of incubators designed to support high humidity because the designers and IVF specialists believed that the humidity will maintain stable ph and Temp.
Recent reports suggest that humidity is recommended and the others suggest no difference So we decide to go for this RCT. Nevertheless; high humidity is maintained in vivo (uterus and fallopian tubes) due to the fluid content and stable body temperatures at 37°C. David McCulloch reported 15% reduction of the miscarriage rate after changing the humidity from 76% to 100% (Textbook of Assisted Reproductive Techniques: Laboratory Perspectives, Fourth Edition). Some embryologists claim that the humidity free incubators may increase the chance of chemical pregnancy and early fetal loss (Private center IbnSina IVF, Sohag, Egypt. unpublished data). This observations are never tested in a well designed randomized clinical trial (RCT) to eliminate the probability of chance and to reach a solid evidence.
The question that should be asked : is high humidity culture should be applied or there is no difference between dry and high humidity culture conditions?
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 |
|---|---|---|
| The Embryos will be cultured on a humidity free incubator | Experimental | Other: The Embryos will be cultured on a humidity free incubatorWe will set the humidity level to 0.0% in the IVF incubator that will be used for culturing the Human embryos after ICSI procedure and we will monitor the outcome embryologically and clinically and record the results. |
| The Embryos will be cultured on a >95% humidity incubator | Placebo comparator | Other: The Embryos will be cultured on a >95% humidity incubatorWe will set the humidity level to > 95% in the IVF incubator that will be used for culturing the Human embryos after ICSI procedure and we will monitor the outcome embryologically and clinically and record the results. |
Who may qualify
- Ages
- 18 to 33 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- < 33 years, BMI<30,
- Normo Responder(>8 MII)
- Fresh Cycle
- Ist attempt
- Normal or mild oligoasthenoteratozoospermia.
Key exclusion criteria (6 listed)
- Testicular sperm
- < 8 MII collected
- difficult transfer cycle
- Endometriotic patients
- Poor Endometrium < 8mm diameter at Ovum Pickup
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 |
|---|---|---|
| The Embryos will be cultured on a humidity free incubatorWe will set the humidity level to 0.0% in the IVF incubator that will be used for culturing the Human embryos after ICSI procedure and we will monitor the outcome embryologically and clinically and record the results. | Other | The Embryos will be cultured on a humidity free incubator |
| The Embryos will be cultured on a >95% humidity incubatorWe will set the humidity level to 95% in the IVF incubator that will be used for culturing the Human embryos after ICSI procedure and we will monitor the outcome embryologically and clinically and record the results. | Other | The Embryos will be cultured on a >95% humidity incubator |
Primary outcome
Ongoing pregnancy rate
Time frame: 18 months
assessing the ongoing pregnancy rate and its difference between the 2 study arms.
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.
- Derived from this study: PubMed 28651960Fawzy M, AbdelRahman MY, Zidan MH, Abdel Hafez FF, Abdelghafar H, Al-Inany H, Bedaiwy MA. Humid versus dry incubator: a prospective, randomized, controlled trial. Fertil Steril. 2017 Aug;108(2):277-283. doi: 10.1016/j.fertnstert.2017.05.036. Epub 2017 Jun 23.
- Facebook group for Gannah hospital, site doing the studyLink provided by the sponsor.
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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
Muhammad El Hady, Lab Director principal investigator
Ganna Hospital
Mohamed Y. Abdel-Rahman, M.D. study director
IBNSINA IVF center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The Embryos will be cultured on a humidity free incubator and The Embryos will be cultured on a >95% humidity incubator in people with Ongoing Pregnancy Rate, run by Ibn Sina Hospital at 2 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 5 inclusion and 6 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 2 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. 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?
Ongoing pregnancy rate (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01695096, which also lists 1 linked publication.
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.