High Versus Free Humidity Incubators; A Randomized Clinical Trial

Study Overview
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Brief Summary
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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
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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 unpublished data).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?

Official Title
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High Versus Free Humidity Incubators; A Randomized Clinical Trial

Conditions
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Ongoing Pregnancy Rate

Intervention / Treatment
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* Other: The Embryos will be cultured on a humidity free incubator
* Other: The Embryos will be cultured on a >95% humidity incubator


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 33 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: The Embryos will be cultured on a humidity free incubator<br>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. | Other: The Embryos will be cultured on a humidity free incubator<br>* 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.<br>|
| Placebo Comparator: The Embryos will be cultured on a >95% humidity incubator<br>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. | Other: The Embryos will be cultured on a >95% humidity incubator<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ongoing pregnancy rate | assessing the ongoing pregnancy rate and its difference between the 2 study arms. | 18 months |