Outcome of Embryo Culture at Two Oxygen Tensions | NCT00718822

Studies
Outcome of Embryo Culture at Two Oxygen Tensions

NCT00718822

Sponsor

University Medical Centre Maribor

Status

Completed

Last Update Posted

Jul 21, 2008Estimated

Enrollment

647Actual

Phase

Not Applicable

Conditions

Embryo Development

Interventions

oxygen concentration in the culture atmosphere

Countries

Slovenia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2008

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2006

Primary Completion Date

Jun 2007Actual

Completion Date

Sep 2007Actual

First Submitted Date

Jul 17, 2008

First Submission Date that Met QC Criteria

Jul 18, 2008

First Posted Date

Jul 21, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 18, 2008

Last Update Posted Date

Jul 21, 2008Estimated

Name	Class
Slovenian Research Agency	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

647Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
oxygen concentration in the culture atmosphere	Other		I II

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Ongoing pregnancy rate per cycle		10-11 weeks after embryo transfer

Secondary Outcomes

Measure	Description	Time Frame
clinical pregnancy rate, implantation rate, early pregnancy loss, fertilization rate, embryo quality

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

stimulated Intra Cytoplasmic Sperm Injection (ICSI) cycle

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

22 Years

Maximum Age

44 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Veljko Vlaisavljević, Prof.	University Medical Centre Maribor	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Clinical Centre Maribor		Maribor		2000	Slovenia