NCT00718822

Brief Summary

The purpose of this study is to assess whether reduced oxygen tension in embryo culture has any effect on clinical outcome.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
647

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2006

Geographic Reach
1 country

1 active site

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

August 1, 2006

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2007

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2007

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

July 17, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 21, 2008

Completed
Last Updated

July 21, 2008

Status Verified

July 1, 2008

Enrollment Period

10 months

First QC Date

July 17, 2008

Last Update Submit

July 18, 2008

Conditions

Embryo Development

Keywords

clinical outcomeICSI cycleslow oxygenpoor responderspregnancy rateprospective randomized study

Outcome Measures

Primary Outcomes (1)

  • Ongoing pregnancy rate per cycle

    10-11 weeks after embryo transfer

Secondary Outcomes (1)

  • clinical pregnancy rate, implantation rate, early pregnancy loss, fertilization rate, embryo quality

Study Arms (2)

I

EXPERIMENTAL

5% oxygen concentration in the culture atmosphere

Other: oxygen concentration in the culture atmosphere

II

EXPERIMENTAL

20% oxygen concentration in the culture atmosphere

Other: oxygen concentration in the culture atmosphere

Interventions

oxygen concentration in the culture atmosphereOTHER
III

Eligibility Criteria

Age22 Years - 44 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • stimulated Intra Cytoplasmic Sperm Injection (ICSI) cycle

You may not qualify if:

  • less than one mature (metaphase II) oocyte at the time of denudation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Clinical Centre Maribor

Maribor, 2000, Slovenia

Location

Study Officials

  • Veljko Vlaisavljević, Prof.

    University Medical Centre Maribor

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 17, 2008

First Posted

July 21, 2008

Study Start

August 1, 2006

Primary Completion

June 1, 2007

Study Completion

September 1, 2007

Last Updated

July 21, 2008

Record last verified: 2008-07

Locations

SL(1)