Clinical trial NCT01695096: High Versus Free Humidity Incubators; A Randomized Clinical Trial
Official title: High Versus Free Humidity Incubators; A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ongoing Pregnancy Rate
Lead sponsor: Ibn Sina Hospital
Sponsor class: OTHER_GOV
Collaborators: name: Ganna Hospital
First posted: 2012-09-27
Enrollment: 284
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 33
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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

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 unpublished data).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 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

Primary outcomes:
measure: Ongoing pregnancy rate
timeFrame: 18 months
Secondary outcomes:
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Gannah IVF unit, Gannah Hospital
city: Sohag
country: Egypt
facility: IbnSina IVF unit, IbnSina Hospital, El Areef Square
Study officials:
affiliation: IBNSINA IVF Center
name: Muhammad F. Abdel-Raheem, Lab Director
role: PRINCIPAL_INVESTIGATOR
affiliation: Ganna Hospital
name: Muhammad El Hady, Lab Director
role: PRINCIPAL_INVESTIGATOR
affiliation: IBNSINA IVF center
name: Mohamed Y. Abdel-Rahman, M.D.
role: STUDY_DIRECTOR
References:
citation: 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.