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OpenTrials
Completed

NCT Number: NCT01695096

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

Completed

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Key information

Conditions

Ongoing Pregnancy Rate

Age range

18 year–33 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Gannah IVF unit, Gannah Hospital, Giza, Giza Governorate, Egypt

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About this study

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 unpublished data).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?

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

The Embryos will be cultured on a humidity free incubator

Other

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

Other

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 outcomes

  1. Ongoing pregnancy rate

    Time frame: 18 months

    assessing the ongoing pregnancy rate and its difference between the 2 study arms.

Sponsors and collaborators

Lead sponsor

Ibn Sina Hospital

Other Gov

Collaborators

  • Ganna Hospital

Registry information

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Sep 27, 2012
Registry last updated
Jun 29, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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