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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
History of Changes
  Purpose

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 Intervention
Low Oxygen Tension
 Other: Decreased oxygen concentration
Other: Control group

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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.

Resource links provided by NLM:

MedlinePlus related topics: Oxygen Therapy
U.S. FDA Resources

Further study details as provided by Instituto Valenciano de Infertilidad, Spain:

Primary Outcome Measures:
  • Clinical pregnancy rates per cycle [ Time Frame: one month ] [ Designated as safety issue: No ]

Enrollment: 380
Study Start Date: November 2009
Study Completion Date: March 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
 Other: Control group
"In Vitro" embryo culture under conventional oxygen concentration

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.

  Eligibility

Ages Eligible for Study:   25 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01532193

Locations
Spain
Ivi Valencia
Valencia, Spain, 46015
Sponsors and Collaborators
Instituto Valenciano de Infertilidad, Spain
  More Information

No publications provided

Responsible Party: Maria Jose Delossantos, Dr. Maria Jose Delossantos, Instituto Valenciano de Infertilidad, Spain
ClinicalTrials.gov Identifier: NCT01532193     History of Changes
Other Study ID Numbers: 0903-C-059-MJ
Study First Received: February 9, 2012
Last Updated: March 26, 2012
Health Authority: Spain: Ministry of Health

ClinicalTrials.gov processed this record on May 16, 2013