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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01532193
Recruitment Status : Completed
First Posted : February 14, 2012
Last Update Posted : August 26, 2015
Information provided by (Responsible Party):
Maria Jose Delossantos, Instituto Valenciano de Infertilidad, IVI VALENCIA

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Low Oxygen Tension Other: Decreased oxygen concentration Not Applicable

Detailed Description:
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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 380 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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.
Study Start Date : November 2009
Actual Primary Completion Date : March 2012
Actual Study Completion Date : March 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Oxygen Therapy

Arm Intervention/treatment
Experimental: Hipoxia
The low oxygen tension group
Other: Decreased oxygen concentration
The oxygen concentration is decreased during the "in Vitro" embryo culture.

No Intervention: Control group
Conventional culture conditions

Primary Outcome Measures :
  1. Clinical pregnancy rates per cycle [ Time Frame: one month ]

Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01532193

Ivi Valencia
Valencia, Spain, 46015
Sponsors and Collaborators
Instituto Valenciano de Infertilidad, IVI VALENCIA

Responsible Party: Maria Jose Delossantos, Dr. Maria Jose Delossantos, Instituto Valenciano de Infertilidad, IVI VALENCIA Identifier: NCT01532193     History of Changes
Other Study ID Numbers: 0903-C-059-MJ
First Posted: February 14, 2012    Key Record Dates
Last Update Posted: August 26, 2015
Last Verified: August 2015