Incubator Temperature for Culturing Human Embryos

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-11-30

Study Completion Date

2015-12-31

Brief Summary

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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.

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Detailed Description

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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).

Conditions

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Embryo Culture

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Incubator Temp 37 degree

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

Group Type PLACEBO_COMPARATOR

Incubator Temp 37 degree

Intervention Type OTHER

We 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

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

Group Type EXPERIMENTAL

Incubator Temp set to 36.5 degree

Intervention Type OTHER

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

Interventions

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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.

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

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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