High Versus Free Humidity Incubators; A Randomized Clinical Trial

Not Applicable

Completed

• Conditions: Ongoing Pregnancy Rate
• Interventions: Other: The Embryos will be cultured on a humidity free incubator; Other: The Embryos will be cultured on a >95% humidity incubator

• Registration Number: NCT01695096
• Lead Sponsor: Ibn Sina Hospital

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 unpublished data).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 Timeline

• Study First Submitted: 2012-09-24
• Study First Submitted QC: 2012-09-26
• Study First Posted: 2012-09-27
• Study Start: 2012-10
• Primary Completion: 2015-10
• Study Completion: 2015-10
• Status Verified: 2016-06
• Last Update Submitted: 2016-06-28
• Last Update Posted: 2016-06-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 284

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
The Embryos will be cultured on a humidity free incubator	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.
The Embryos will be cultured on a >95% humidity incubator	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.

Primary Outcome Measures

Name	Time	Method
Ongoing pregnancy rate	18 months	assessing the ongoing pregnancy rate and its difference between the 2 study arms.

Trial Locations

Locations (2)

IbnSina IVF unit, IbnSina Hospital, El Areef Square; 🇪🇬 Sohag, Egypt

Gannah IVF unit, Gannah Hospital; 🇪🇬 Giza, Egypt