Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Incubator Temperature for Culturing Human Embryos

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2012 by Ibn Sina Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Muhammad Fawzy, Ibn Sina Hospital
ClinicalTrials.gov Identifier:
NCT01706900
First received: October 10, 2012
Last updated: January 31, 2013
Last verified: October 2012
  Purpose

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 Intervention
Embryo Culture
Other: Incubator Temp set to 36.5 degree
Other: Incubator Temp 37 degree

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Incubator Temperature for Culturing Human Embryos

Further study details as provided by Ibn Sina Hospital:

Primary Outcome Measures:
  • Fetal heart beat rate [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Compare the fetal heart beat rate between the 2 study arms in the first 3 months following Embryo Transfer.


Secondary Outcome Measures:
  • Pregnancy rate [ Time Frame: one month ] [ Designated as safety issue: No ]
    Measure the pregnancy rate between the 2 study arms in the following one month after Embryo Transfer

  • Top quality embryos Day3 [ Time Frame: one week ] [ Designated as safety issue: No ]
    Measure the top quality embryos day3 between the 2 study arms in the following week after ICSI

  • blastocyst formation rate [ Time Frame: one week ] [ Designated as safety issue: No ]
    Measure the blastocyst formation rate between the 2 study arms in the following week after ICSI

  • Top quality blastocyst [ Time Frame: one week ] [ Designated as safety issue: No ]
    Measure the top quality blastocyst rate between the 2 study arms in the following week after ICSI

  • Implantation rate [ Time Frame: one month ] [ Designated as safety issue: No ]
    Measure the implantation rate between the 2 study arms in the following first month after Embryo Transfer


Other Outcome Measures:
  • Cleavage rate on day 3 [ Time Frame: one month ] [ Designated as safety issue: No ]
    We will measure the rate of embryo cleavage on day3 between the 2 study arms


Estimated Enrollment: 280
Study Start Date: November 2012
Estimated Study Completion Date: May 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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).

  Eligibility

Ages Eligible for Study:   18 Years to 33 Years
Genders 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01706900

Locations
Egypt
IbnSina IVF Center, IbnSina Hospital Recruiting
Sohag, Egypt, 12345
Contact: Muhammad F. Abdel-Raheem, Lab Director    +201116604600    drfawzy001@gmail.com   
Contact: Mohamed Y. Abdel-Rahman, M.D.    +201142456788    dryahyaz@yahoo.com   
Principal Investigator: Muhammad F. Abdel-Raheem, Lab Director         
Principal Investigator: Mohamed Y. Abdel-Rahman, M.D.         
Sub-Investigator: Ahmed M. El-Abody, Embryologist         
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
  More Information

No publications provided

Responsible Party: Muhammad Fawzy, IVF Laboratory Director, Ibn Sina Hospital
ClinicalTrials.gov Identifier: NCT01706900     History of Changes
Other Study ID Numbers: IbnSina Hospital
Study First Received: October 10, 2012
Last Updated: January 31, 2013
Health Authority: Egypt: Ministry of Health and Population

ClinicalTrials.gov processed this record on November 25, 2014