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

August 25, 2015 updated by: Maria Jose Delossantos, Instituto Valenciano de Infertilidad, IVI VALENCIA

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

380

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Valencia, Spain, 46015
        • IVI Valencia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Clinical pregnancy rates per cycle
Time Frame: one month
one month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Instituto Valenciano de Infertilidad, IVI VALENCIA

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2009

Primary Completion (Actual)

March 1, 2012

Study Completion (Actual)

March 1, 2012

Study Registration Dates

First Submitted

February 9, 2012

First Submitted That Met QC Criteria

February 13, 2012

First Posted (Estimate)

February 14, 2012

Study Record Updates

Last Update Posted (Estimate)

August 26, 2015

Last Update Submitted That Met QC Criteria

August 25, 2015

Last Verified

August 1, 2015

More Information

Terms related to this study

Other Study ID Numbers

  • 0903-C-059-MJ

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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