Impact of Culture Medium on Embryo Quality | NCT01094314

Studies
Impact of Culture Medium on Embryo Quality

NCT01094314

Sponsor

University Hospital, Gasthuisberg

Status

Completed

Last Update Posted

Mar 26, 2010Estimated

Enrollment

790Estimated

Phase

Not Applicable

Conditions

Embryo Development

Interventions

embryo culture medium

Countries

Belgium

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

Mar 2010

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

Jan 2008

Primary Completion Date

Apr 2009Actual

Completion Date

Apr 2009Actual

First Submitted Date

Mar 25, 2010

First Submission Date that Met QC Criteria

Mar 25, 2010

First Posted Date

Mar 26, 2010Estimated

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

Mar 25, 2010

Last Update Posted Date

Mar 26, 2010Estimated

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

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

790Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
sequential medium	Active Comparator		Other: embryo culture medium
single medium	Active Comparator		Other: embryo culture medium

Interventions

Name	Type	Description	Arm Group Labels	Other Names
embryo culture medium	Other	comparison between two types of embryo culture medium	sequential medium single medium

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
embryo quality: number and size of blastomeres, degree of fragmentation		day 1 -day 3

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Embryos of patients younger than 36 years old

Exclusion Criteria:

Embryos of patients older than 36 years old

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

1 Day

Maximum Age

3 Days

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Hospital Leuven, Catholic University Leuven		Leuven		3000	Belgium

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
20609226	Derived	Paternot G, Debrock S, D'Hooghe TM, Spiessens C. Early embryo development in a sequential versus single medium: a randomized study. Reprod Biol Endocrinol. 2010 Jul 7;8:83. doi: 10.1186/1477-7827-8-83.