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

NCT ID: NCT01532193

Last Updated: 2015-08-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

380 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-11-30

Study Completion Date

2012-03-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Low Oxygen Tension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Hipoxia

The low oxygen tension group

Group Type EXPERIMENTAL

Decreased oxygen concentration

Intervention Type OTHER

The oxygen concentration is decreased during the "in Vitro" embryo culture.

Control group

Conventional culture conditions

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Decreased oxygen concentration

The oxygen concentration is decreased during the "in Vitro" embryo culture.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

25 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Instituto Valenciano de Infertilidad, IVI VALENCIA

OTHER

Sponsor Role lead

Responsible Party

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Maria Jose Delossantos

Dr. Maria Jose Delossantos

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Ivi Valencia

Valencia, , Spain

Site Status

Countries

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Spain

References

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Rendon Abad M, Serra V, Gamiz P, de Los Santos JM, Remohi J, Navarro AT, de Los Santos MJ. The influence of oxygen concentration during embryo culture on obstetric and neonatal outcomes: a secondary analysis of a randomized controlled trial. Hum Reprod. 2020 Sep 1;35(9):2017-2025. doi: 10.1093/humrep/deaa152.

Reference Type DERIVED
PMID: 32772073 (View on PubMed)

Other Identifiers

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0903-C-059-MJ

Identifier Type: -

Identifier Source: org_study_id

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