Incubator Temperature for Culturing Human Embryos
1 other identifier
interventional
400
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Nov 2012
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 10, 2012
CompletedFirst Posted
Study publicly available on registry
October 15, 2012
CompletedStudy Start
First participant enrolled
November 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2015
CompletedJune 29, 2016
June 1, 2016
3.1 years
October 10, 2012
June 28, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (5)
Pregnancy rate
one month
Top quality embryos Day3
one week
blastocyst formation rate
one week
Top quality blastocyst
one week
Implantation rate
one month
Other Outcomes (1)
Cleavage rate on day 3
one month
Study Arms (2)
Incubator Temp 37 degree
PLACEBO COMPARATORWe will set incubator Temp to 37 degree as the routine embryo culture Temp since 1978 as the placebo arm.
Incubator Temp set to 36.5 degree
EXPERIMENTALWe will set incubator Temp to 36.5 so we can assess the outcome and compare the results with the placebo group.
Interventions
We will set incubator Temp to 36.5 so we can assess the outcome and compare the results with the placebo group.
We will set incubator Temp to 37 degree as the routine embryo culture Temp since 1978 as the placebo arm.
Eligibility Criteria
You may qualify if:
- Women aged ≤ 33 years
- BMI ≤ 33
- Normal responder ( ≥ 8 MII )
- Fresh cycle
- First attempt (or with previous successful attempt)
- Normal or mild oligoasthenoteratozoospermia
You may not qualify if:
- Testicular sperm
- \< 8 MIII collected
- Difficult transfer cycle
- endometriotic patients
- Poor Endometrium \< 8mm diameter at OPU
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
IbnSina IVF Center, IbnSina Hospital
Sohag, Sohag Governorate, 12345, Egypt
Study Officials
- 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
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- IVF Laboratory Director
Study Record Dates
First Submitted
October 10, 2012
First Posted
October 15, 2012
Study Start
November 1, 2012
Primary Completion
December 1, 2015
Study Completion
December 1, 2015
Last Updated
June 29, 2016
Record last verified: 2016-06