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High Versus Free Humidity Incubators; A Randomized Clinical Trial

This study has been completed.
Sponsor:
Collaborator:
Gannah Hospital
Information provided by (Responsible Party):
Muhammad Fawzy, Ibn Sina Hospital
ClinicalTrials.gov Identifier:
NCT01695096
First received: September 24, 2012
Last updated: June 28, 2016
Last verified: June 2016
  Purpose
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

Condition Intervention
Ongoing Pregnancy Rate
Other: The Embryos will be cultured on a humidity free incubator
Other: The Embryos will be cultured on a >95% humidity incubator

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: High Versus Free Humidity Incubators; A Randomized Clinical Trial

Further study details as provided by Ibn Sina Hospital:

Primary Outcome Measures:
  • Ongoing pregnancy rate [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    assessing the ongoing pregnancy rate and its difference between the 2 study arms.


Enrollment: 284
Study Start Date: October 2012
Study Completion Date: October 2015
Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
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.
Placebo Comparator: 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.
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.

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?

  Eligibility

Ages Eligible for Study:   18 Years to 33 Years   (Adult)
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01695096

Locations
Egypt
Gannah IVF unit, Gannah Hospital
Giza, Egypt, 12345
IbnSina IVF unit, IbnSina Hospital, El Areef Square
Sohag, Egypt, 12345
Sponsors and Collaborators
Ibn Sina Hospital
Gannah Hospital
Investigators
Principal Investigator: Muhammad F. Abdel-Raheem, Lab Director IBNSINA IVF Center
Principal Investigator: Muhammad El Hady, Lab Director Gannah Hospital
Study Director: Mohamed Y. Abdel-Rahman, M.D. IBNSINA IVF center
  More Information

Additional Information:
Responsible Party: Muhammad Fawzy, IVF Laboratory Director, Ibn Sina Hospital
ClinicalTrials.gov Identifier: NCT01695096     History of Changes
Other Study ID Numbers: ibnsinaH  ibnsinaH 
Study First Received: September 24, 2012
Last Updated: June 28, 2016
Health Authority: Egypt: Ministry of Health and Population

ClinicalTrials.gov processed this record on September 23, 2016