Incubator Temperature for Culturing Human Embryos

Embryo Culture Clinical Trial

Official title:

Incubator Temperature for Culturing Human Embryos

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01706900
• Other study ID #: IbnSina Hospital
• Status: Completed
• Phase: N/A
• First received: October 10, 2012
• Last updated: June 28, 2016
• Start date: November 2012
• Est. completion date: December 2015

Study information

• Verified date: June 2016
• Source: Ibn Sina Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Egypt: Ministry of Health and Population
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 33 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Embryo Culture

Intervention

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.
• Incubator Temp 37 degree
We will set incubator Temp to 37 degree as the routine embryo culture Temp since 1978 as the placebo arm.

Locations

Country	Name	City	State
Egypt	IbnSina IVF Center, IbnSina Hospital	Sohag

Sponsors (1)

Lead Sponsor	Collaborator
Ibn Sina Hospital

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Cleavage rate on day 3	We will measure the rate of embryo cleavage on day3 between the 2 study arms	one month	No
Primary	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	No
Secondary	Pregnancy rate	Measure the pregnancy rate between the 2 study arms in the following one month after Embryo Transfer	one month	No
Secondary	Top quality embryos Day3	Measure the top quality embryos day3 between the 2 study arms in the following week after ICSI	one week	No
Secondary	blastocyst formation rate	Measure the blastocyst formation rate between the 2 study arms in the following week after ICSI	one week	No
Secondary	Top quality blastocyst	Measure the top quality blastocyst rate between the 2 study arms in the following week after ICSI	one week	No
Secondary	Implantation rate	Measure the implantation rate between the 2 study arms in the following first month after Embryo Transfer	one month	No