Incubator Temperature for Culturing Human Embryos

Incubator temperature is one of the most precious variables in IVF labs. When the IVF started, almost all incubator temperatures were set at 37 degrees which mimic in vivo conditions. Some authors speculated that gametes and early embryos might need low temperatures that provide quieter metabolism. We decide to compare Embryo culture at 37 degree or slightly lower 36.5 degree and extensively investigate to find which is better to crucially introduce a solid evidence through this RCT.

Study Overview

• Status: Completed
• Conditions: Embryo Culture
• Intervention / Treatment: Other: Incubator Temp 37 degree; Other: Incubator Temp set to 36.5 degree

Detailed Description

Since the first IVF birth in 1978, the field of assisted reproductive technology has evolved dramatically. The evolution includes both the ovarian stimulation protocols and the laboratory techniques. Optimization of the laboratory procedures is of great interest to the scientists in the field of IVF.

Incubator temperature is one of the most precious variables in IVF labs. When the IVF started, almost all incubator temperatures were set at 37 degrees which mimic in vivo conditions.

Some authors speculated that gametes and early embryos might need low temperatures that provide quieter metabolism. another group found increase in pregnancy rate for embryos cultured below 37 degree compared to those cultured at 37 degree. Nevertheless; the majority of embryologists still consider culture at 37 degrees is the back bone for the incubators.

The paucity of well designed studies makes it difficult to achieve a satisfactory answer whether lower temperature will improve the pregnancy rate. This encourage us to study the effect of lower temperature (36.5 degrees) on the pregnancy rate compared to conventional temperature (37 degrees).

• Study Type: Interventional
• Enrollment (Actual): 400
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Sohag, Egypt, 12345
    • IbnSina IVF Center, IbnSina Hospital

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:

• Women aged ≤ 33 years
• BMI ≤ 33
• Normal responder ( ≥ 8 MII )
• Fresh cycle
• First attempt (or with previous successful attempt)
• Normal or mild oligoasthenoteratozoospermia

Exclusion Criteria:

• Testicular sperm
• < 8 MIII collected
• Difficult transfer cycle
• endometriotic patients
• Poor Endometrium < 8mm diameter at OPU

Study Plan

How is the study designed?

Design Details

• Primary Purpose: HEALTH_SERVICES_RESEARCH
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: Incubator Temp 37 degree; We will set incubator Temp to 37 degree as the routine embryo culture Temp since 1978 as the placebo arm.	Other: Incubator Temp 37 degree; We will set incubator Temp to 37 degree as the routine embryo culture Temp since 1978 as the placebo arm.
EXPERIMENTAL: Incubator Temp set to 36.5 degree; We will set incubator Temp to 36.5 so we can assess the outcome and compare the results with the placebo group.	Other: Incubator Temp set to 36.5 degree; We will set incubator Temp to 36.5 so we can assess the outcome and compare the results with the placebo group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fetal heart beat rate	Compare the fetal heart beat rate between the 2 study arms in the first 3 months following Embryo Transfer.	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pregnancy rate	Measure the pregnancy rate between the 2 study arms in the following one month after Embryo Transfer	one month
Top quality embryos Day3	Measure the top quality embryos day3 between the 2 study arms in the following week after ICSI	one week
blastocyst formation rate	Measure the blastocyst formation rate between the 2 study arms in the following week after ICSI	one week
Top quality blastocyst	Measure the top quality blastocyst rate between the 2 study arms in the following week after ICSI	one week
Implantation rate	Measure the implantation rate between the 2 study arms in the following first month after Embryo Transfer	one month

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cleavage rate on day 3	We will measure the rate of embryo cleavage on day3 between the 2 study arms	one month

Collaborators and Investigators

• Sponsor: Ibn Sina Hospital
• Investigators: Principal Investigator: Mohamed Y. Abdel-Rahman, M.D., IbnSina IVF Center; Principal Investigator: Hesham A. Kasem, Gynaecologist, IbnSina IVF Center

Study record dates

Study Major Dates

• Study Start: November 1, 2012
• Primary Completion (ACTUAL): December 1, 2015
• Study Completion (ACTUAL): December 1, 2015

Study Registration Dates

• First Submitted: October 10, 2012
• First Submitted That Met QC Criteria: October 12, 2012
• First Posted (ESTIMATE): October 15, 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: IbnSina Hospital