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The Effect of Embryo Culture Under Low Oxygen Tension on Pregnancy Rates

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ClinicalTrials.gov Identifier: NCT01532193
Recruitment Status : Completed
First Posted : February 14, 2012
Last Update Posted : August 26, 2015
Information provided by (Responsible Party):

February 9, 2012
February 14, 2012
August 26, 2015
November 2009
March 2012   (Final data collection date for primary outcome measure)
Clinical pregnancy rates per cycle [ Time Frame: one month ]
Same as current
Complete list of historical versions of study NCT01532193 on ClinicalTrials.gov Archive Site
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The Effect of Embryo Culture Under Low Oxygen Tension on Pregnancy Rates
A Randomized Controlled Trial Evaluation the Effect of Low Oxygen Tension on the Pregnancy Rate After Day 3 Embryo Transfer in an Egg Donation Programme.
This study will determine whether the use of low oxygen tension during "in vitro" embryo culture may increase the pregnancy rates in women undergoing egg donation.
As far as oxygen (O2) tension is concerned, both oocytes and embryos from different mammalian species included the human are normally surrounded by values which are much less than half of atmospheric O2, ranging from high (8.7% O2) in the rabbit oviduct, rabbit and hamster uterus, to as low as 11 mm Hg (1.5% O2) in the monkey uterus. Even in the preovulatory follicle, oocytes are bathed within follicular fluids containing oxygen that range from > 1 to 5.5 % The aim of this study was to evaluate the impact the effect of low oxygen tension after day-3 embryo transfer in our egg donation programme on pregnancy and implantation rates.
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Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Low Oxygen Tension
Other: Decreased oxygen concentration
The oxygen concentration is decreased during the "in Vitro" embryo culture.
  • Experimental: Hipoxia
    The low oxygen tension group
    Intervention: Other: Decreased oxygen concentration
  • No Intervention: Control group
    Conventional culture conditions
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
March 2012
March 2012   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Women aged 25-45 years of age;
  • In good mental and physical health;
  • First or second of egg-recipient treatment;
  • Embryo transfer on Day 3.
  • One to three embryos will be transferred.
  • BMI between 18-25 kg/m2.

Exclusion Criteria:

  • Uterine pathology or hydrosalpinx
  • Recurrent miscarriage
  • No chronic illnesses
Sexes Eligible for Study: Female
25 Years to 45 Years   (Adult)
Contact information is only displayed when the study is recruiting subjects
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Maria Jose Delossantos, Instituto Valenciano de Infertilidad, IVI VALENCIA
Instituto Valenciano de Infertilidad, IVI VALENCIA
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Instituto Valenciano de Infertilidad, IVI VALENCIA
August 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP