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

Low Oxygen Tension Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01532193
• Other study ID #: 0903-C-059-MJ
• Status: Completed
• Phase: N/A
• First received: February 9, 2012
• Last updated: August 25, 2015
• Start date: November 2009
• Est. completion date: March 2012

Study information

• Verified date: August 2015
• Source: Instituto Valenciano de Infertilidad, IVI VALENCIA
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 380
• Est. completion date: March 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 25 Years to 45 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Low Oxygen Tension

Intervention

Other:
• Decreased oxygen concentration
The oxygen concentration is decreased during the "in Vitro" embryo culture.

Locations

Country	Name	City	State
Spain	Ivi Valencia	Valencia

Sponsors (1)

Lead Sponsor	Collaborator
Instituto Valenciano de Infertilidad, IVI VALENCIA

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical pregnancy rates per cycle		one month	No