High Versus Free Humidity Incubators; A Randomized Clinical Trial

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

284 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-10-31

Study Completion Date

2015-10-31

Brief Summary

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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

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Detailed Description

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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 unpublished data).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?

Conditions

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Ongoing Pregnancy Rate

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

The Embryos will be cultured on a humidity free incubator

Intervention Type 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

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.

Group Type PLACEBO_COMPARATOR

The Embryos will be cultured on a >95% humidity incubator

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

33 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes