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Incubator Temperature for Culturing Human Embryos

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ClinicalTrials.gov Identifier: NCT01706900
Recruitment Status : Completed
First Posted : October 15, 2012
Last Update Posted : June 29, 2016
Sponsor:
Information provided by (Responsible Party):
Muhammad Fawzy, Ibn Sina Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment
Embryo Culture Other: Incubator Temp set to 36.5 degree Other: Incubator Temp 37 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  (Clinical Trial)
Actual Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Incubator Temperature for Culturing Human Embryos
Study Start Date : November 2012
Primary Completion Date : December 2015
Study Completion Date : December 2015

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.



Primary Outcome Measures :
  1. Fetal heart beat rate [ Time Frame: 3 months ]
    Compare the fetal heart beat rate between the 2 study arms in the first 3 months following Embryo Transfer.


Secondary Outcome Measures :
  1. Pregnancy rate [ Time Frame: one month ]
    Measure the pregnancy rate between the 2 study arms in the following one month after Embryo Transfer

  2. Top quality embryos Day3 [ Time Frame: one week ]
    Measure the top quality embryos day3 between the 2 study arms in the following week after ICSI

  3. blastocyst formation rate [ Time Frame: one week ]
    Measure the blastocyst formation rate between the 2 study arms in the following week after ICSI

  4. Top quality blastocyst [ Time Frame: one week ]
    Measure the top quality blastocyst rate between the 2 study arms in the following week after ICSI

  5. Implantation rate [ Time Frame: one month ]
    Measure the implantation rate between the 2 study arms in the following first month after Embryo Transfer


Other Outcome Measures:
  1. Cleavage rate on day 3 [ Time Frame: one month ]
    We will measure the rate of embryo cleavage on day3 between the 2 study arms



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Ages Eligible for Study:   18 Years to 33 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01706900


Locations
Egypt
IbnSina IVF Center, IbnSina Hospital
Sohag, Egypt, 12345
Sponsors and Collaborators
Ibn Sina Hospital
Investigators
Principal Investigator: Muhammad F. Abdel-Raheem, Lab Director IbnSina IVF Center
Principal Investigator: Mohamed Y. Abdel-Rahman, M.D. IbnSina IVF center
Principal Investigator: Hesham A. Kasem, Gynaecologist IbnSina IVF Center

Responsible Party: Muhammad Fawzy, IVF Laboratory Director, Ibn Sina Hospital
ClinicalTrials.gov Identifier: NCT01706900     History of Changes
Other Study ID Numbers: IbnSina Hospital
First Posted: October 15, 2012    Key Record Dates
Last Update Posted: June 29, 2016
Last Verified: June 2016