NCT01767805

Brief Summary

The purpose of this study is to compare different culture conditions. The effect of the type of incubator (standard versus mini-incubator) and the effect of the oxygen concentration (5% versus 20%) will be evaluated on the embryo quality

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
790

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2009

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2009

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2010

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2011

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

January 8, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 14, 2013

Completed
Last Updated

January 14, 2013

Status Verified

January 1, 2013

Enrollment Period

1.3 years

First QC Date

January 8, 2013

Last Update Submit

January 10, 2013

Conditions

Embryo Development

Outcome Measures

Primary Outcomes (1)

  • embryo quality

    day 1- day 3

Study Arms (2)

Type of incubator

OTHER

Embryos are cultured in a standard incubator or a mini-incubator

Procedure: Standard incubatorProcedure: Mini incubator

Oxygen concentration

OTHER

Embryos are cultured in an incubator with a gas mixture with 20% oxygen or with 5% oxygen

Procedure: 5% oxygenProcedure: 20% oxygen

Interventions

Standard incubatorPROCEDURE
Type of incubator
Mini incubatorPROCEDURE
Type of incubator
5% oxygenPROCEDURE
Oxygen concentration
20% oxygenPROCEDURE
Oxygen concentration

Eligibility Criteria

Age1 Day - 3 Days
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • embryos of patients younger than 36 years old

You may not qualify if:

  • embryos of patients older than 36 years old

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University Hospital Leuven, Catholic University Leuven

Leuven, Leuven, 3000, Belgium

Location

University Hospital Leuven, Catholic University Leuven

Leuven, Belgium

Location

MeSH Terms

Interventions

Oxygen

Intervention Hierarchy (Ancestors)

ChalcogensElementsInorganic ChemicalsGases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr.

Study Record Dates

First Submitted

January 8, 2013

First Posted

January 14, 2013

Study Start

June 1, 2009

Primary Completion

September 1, 2010

Study Completion

September 1, 2011

Last Updated

January 14, 2013

Record last verified: 2013-01

Locations

BE(2)