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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Maria Jose Delossantos, Instituto Valenciano de Infertilidad, Spain
ClinicalTrials.gov Identifier:
NCT01532193
First received: February 9, 2012
Last updated: March 26, 2012
Last verified: March 2012

February 9, 2012
March 26, 2012
November 2009
March 2012   (final data collection date for primary outcome measure)
Clinical pregnancy rates per cycle [ Time Frame: one month ] [ Designated as safety issue: No ]
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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Low Oxygen Tension
  • Other: Decreased oxygen concentration
    The oxygen concentration is decreased during the "in Vitro" embryo culture.
  • Other: Control group
    "In Vitro" embryo culture under conventional oxygen concentration
  • Experimental: Hipoxia
    The low oxygen tension group
    Intervention: Other: Decreased oxygen concentration
  • No Intervention: Control group
    Conventional culture conditions
    Intervention: Other: Control group
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
380
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
Female
25 Years to 45 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Spain
 
NCT01532193
0903-C-059-MJ
No
Maria Jose Delossantos, Instituto Valenciano de Infertilidad, Spain
Instituto Valenciano de Infertilidad, IVI VALENCIA
Not Provided
Not Provided
Instituto Valenciano de Infertilidad, IVI VALENCIA
March 2012

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