High Versus Free Humidity Incubators; A Randomized Clinical Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Ibn Sina Hospital
- Enrollment
- 284
- Locations
- 2
- Primary Endpoint
- Ongoing pregnancy rate
Study Overview
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 unpublished data).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?
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Health Services Research
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 33 Years (Adult)
- Sex
- Female
- Accepts 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
Arms & Interventions
The 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.
Intervention: The Embryos will be cultured on a humidity free incubator (Other)
The 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.
Intervention: The Embryos will be cultured on a >95% humidity incubator (Other)
Outcomes
Primary Outcomes
Ongoing pregnancy rate
Time Frame: 18 months
assessing the ongoing pregnancy rate and its difference between the 2 study arms.
Secondary Outcomes
No secondary outcomes reported
Investigators
Muhammad Fawzy
IVF Laboratory Director
Ibn Sina Hospital