High Versus Free Humidity Incubators; A Randomized Clinical Trial

Ongoing Pregnancy Rate Clinical Trial

Official title:

High Versus Free Humidity Incubators; A Randomized Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01695096
• Other study ID #: ibnsinaH
• Secondary ID: ibnsinaH
• Status: Completed
• Phase: N/A
• First received: September 24, 2012
• Last updated: June 28, 2016
• Start date: October 2012
• Est. completion date: October 2015

Study information

• Verified date: June 2016
• Source: Ibn Sina Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Egypt: Ministry of Health and Population
• Study type: Interventional

Clinical 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

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 unpublished data).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?

Recruitment information / eligibility

• Status: Completed
• Enrollment: 284
• Est. completion date: October 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 33 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Ongoing Pregnancy Rate

Intervention

Other:
• 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
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.

Locations

Country	Name	City	State
Egypt	Gannah IVF unit, Gannah Hospital	Giza
Egypt	IbnSina IVF unit, IbnSina Hospital, El Areef Square	Sohag

Sponsors (2)

Lead Sponsor	Collaborator
Ibn Sina Hospital	Gannah Hospital

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ongoing pregnancy rate	assessing the ongoing pregnancy rate and its difference between the 2 study arms.	18 months	No

External Links

•   Facebook group for Gannah hospital, site doing the study