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Completed

NCT Number: NCT01706900

Incubator Temperature for Culturing Human Embryos

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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Key information

Conditions

Age range

18 year–33 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

IbnSina IVF Center, IbnSina Hospital

Sohag, Sohag Governorate, 12345, Egypt

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Incubator Temp set to 36.5 degree

Other

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

Other

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

Primary outcomes

  1. Fetal heart beat rate

    Time frame: 3 months

    Compare the fetal heart beat rate between the 2 study arms in the first 3 months following Embryo Transfer.

Secondary outcomes

  1. Pregnancy rate

    Time frame: one month

    Measure the pregnancy rate between the 2 study arms in the following one month after Embryo Transfer

  2. Top quality embryos Day3

    Time frame: one week

    Measure the top quality embryos day3 between the 2 study arms in the following week after ICSI

  3. blastocyst formation rate

    Time frame: one week

    Measure the blastocyst formation rate between the 2 study arms in the following week after ICSI

  4. Top quality blastocyst

    Time frame: one week

    Measure the top quality blastocyst rate between the 2 study arms in the following week after ICSI

  5. Implantation rate

    Time frame: one month

    Measure the implantation rate between the 2 study arms in the following first month after Embryo Transfer

Other outcomes

  1. Cleavage rate on day 3

    Time frame: one month

    We will measure the rate of embryo cleavage on day3 between the 2 study arms

Sponsors and collaborators

Lead sponsor

Ibn Sina Hospital

Other Gov

Registry information

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Oct 15, 2012
Registry last updated
Jun 29, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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