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High Versus Free Humidity Incubators; A Randomized Clinical Trial

High Versus Free Humidity Incubators; A Randomized Clinical Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01695096
Enrollment
284
Registered
2012-09-27
Start date
2012-10-31
Completion date
2015-10-31
Last updated
2016-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ongoing Pregnancy Rate

Brief 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

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 unpublished data).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?

Interventions

OTHERThe Embryos will be cultured on a humidity free incubator

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.

OTHERThe Embryos will be cultured on a >95% humidity incubator

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.

Sponsors

Ganna Hospital
CollaboratorOTHER
Ibn Sina Hospital
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 33 Years
Healthy volunteers
Yes

Inclusion criteria

* \< 33 years, BMI\<30, * Normo Responder(\>8 MII) * Fresh Cycle * Ist attempt * Normal or mild oligoasthenoteratozoospermia.

Exclusion criteria

* Testicular sperm * \< 8 MII collected * difficult transfer cycle * Endometriotic patients * Poor Endometrium \< 8mm diameter at Ovum Pickup * any other medical diseases

Design outcomes

Primary

MeasureTime frameDescription
Ongoing pregnancy rate18 monthsassessing the ongoing pregnancy rate and its difference between the 2 study arms.

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 9, 2026