High Versus Free Humidity Incubators; A Randomized Clinical Trial

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

Study Overview

• Status: Completed
• Conditions: Ongoing Pregnancy Rate
• Intervention / Treatment: Other: The Embryos will be cultured on a humidity free incubator; Other: The Embryos will be cultured on a >95% humidity incubator

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 unpublished data).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 Type: Interventional
• Enrollment (Actual): 284
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Giza, Egypt, 12345
    • Gannah IVF unit, Gannah Hospital
  • Sohag, Egypt, 12345
    • IbnSina IVF unit, IbnSina Hospital, El Areef Square

Participation Criteria

Eligibility Criteria

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

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Ibn Sina Hospital
• Collaborators: Ganna Hospital
• Investigators: Principal Investigator: Muhammad El Hady, Lab Director, Ganna Hospital; Study Director: Mohamed Y. Abdel-Rahman, M.D., IbnSina IVF Center

Publications and helpful links

General Publications

• Fawzy M, AbdelRahman MY, Zidan MH, Abdel Hafez FF, Abdelghafar H, Al-Inany H, Bedaiwy MA. Humid versus dry incubator: a prospective, randomized, controlled trial. Fertil Steril. 2017 Aug;108(2):277-283. doi: 10.1016/j.fertnstert.2017.05.036. Epub 2017 Jun 23. Erratum In: Fertil Steril. 2021 Apr;115(4):1087.

Helpful Links

• Facebook group for Gannah hospital, site doing the study

Study record dates

Study Major Dates

• Study Start: October 1, 2012
• Primary Completion (Actual): October 1, 2015
• Study Completion (Actual): October 1, 2015

Study Registration Dates

• First Submitted: September 24, 2012
• First Submitted That Met QC Criteria: September 26, 2012
• First Posted (Estimate): September 27, 2012

Study Record Updates

• Last Update Posted (Estimate): June 29, 2016
• Last Update Submitted That Met QC Criteria: June 28, 2016
• Last Verified: June 1, 2016

More Information

Terms related to this study

• Other Study ID Numbers: ibnsinaH (Other Identifier: ibnsinaH)