Incubator Temperature for Culturing Human Embryos

Ibn Sina Hospital

Status: Completed

Conditions: Embryo Culture

Treatments: Other: Incubator Temp 37 degree; Other: Incubator Temp set to 36.5 degree

Study type: Interventional

Funder types: Other

Identifiers

NCT01706900

IbnSina Hospital

Details and patient eligibility

About

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.

Full 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).

Enrollment: 400 patients

Sex: Female

Ages: 18 to 33 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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400 participants in 2 patient groups, including a placebo group

Incubator Temp 37 degree

Placebo Comparator group

Description:

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

Treatment:

Other: Incubator Temp 37 degree

Incubator Temp set to 36.5 degree

Experimental group

Description:

We will set incubator Temp to 36.5 so we can assess the outcome and compare the results with the placebo group.

Treatment:

Other: Incubator Temp set to 36.5 degree