High Versus Free Humidity Incubators; A Randomized Clinical Trial

Ibn Sina Hospital

Status: Completed

Conditions: Ongoing Pregnancy Rate

Treatments: Other: The Embryos will be cultured on a >95% humidity incubator; Other: The Embryos will be cultured on a humidity free incubator

Study type: Interventional

Funder types: Other

Identifiers

NCT01695096

ibnsinaH (Other Identifier)

Details and patient eligibility

About

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

Full 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 unpublished data).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?

Enrollment: 284 patients

Sex: Female

Ages: 18 to 33 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

284 participants in 2 patient groups, including a placebo group

The Embryos will be cultured on a humidity free incubator

Experimental group

Description:

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.

Treatment:

Other: The Embryos will be cultured on a humidity free incubator

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

Placebo Comparator group

Description:

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.

Treatment:

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