Oxygen Tension on Human Embryonic Development

NCT03964805 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 773

Last updated 2019-05-28

No results posted yet for this study

Summary

In mammals, uterine environment is at low oxygen concentration (2-8% O2). Thus, human embryo culture under low O2 tension (5%) is now recommended by European Society of Human Reproduction and Embryology (ESHRE) revised guidelines for good practices in in vitro fertilization (IVF) labs. Indeed, hypoxia seems to improve embryo quality at cleavage and blastocyst stages, presumably by reducing damages of oxidative stress (OS). Nevertheless, recent meta-analyses concluded only with a low evidence to a superiority of hypoxia on IVF/ICSI outcomes. Furthermore, a study on mouse embryos suggested a negative impact of OS only at cleavage stage. The aim of the present prospective randomized study was to investigate this hypothesis for the first time in human embryos.

Conditions

Interventions

OTHER

20% oxygen

culture excusively at 20% O2 (Day 0 to Day 6)

OTHER

5% oxygen

culture excusively at 5% O2 (Day 0 to Day 6)

OTHER

20 % and 5 % oxygen

culture at 5% from Day 0 to Day 3, then at 20% from Day 3 to Day 6)

Sponsors & Collaborators

  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Principal Investigators

  • Christophe Sifer · AP-HP_Hôpital Jean Verdier

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
39 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-09-01
Primary Completion
2018-09-06
Completion
2018-12-01

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03964805 on ClinicalTrials.gov