Comparison of Single vs Group Embryo Culture in Micro-wel... | NCT02050516

Studies
Comparison of Single vs Group Embryo Culture in Micro-well Group Culture Dish

NCT02050516

Sponsor

Elif Güler Ergin

Status

Unknown status

Last Update Posted

Jan 31, 2014Estimated

Enrollment

160Estimated

Phase

Not Applicable

Conditions

Infertility

Interventions

micro-well group culture dish

Countries

Turkey (Türkiye)

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

Jan 2014

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2013

Primary Completion Date

Jan 2014Actual

Completion Date

Jul 2014Estimated

First Submitted Date

Jan 29, 2014

First Submission Date that Met QC Criteria

Jan 29, 2014

First Posted Date

Jan 30, 2014Estimated

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

Jan 30, 2014

Last Update Posted Date

Jan 31, 2014Estimated

Name	Class
Vitrolife	INDUSTRY

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

Does group culture using micro-well group culture dishes improve human blastocyst development compared to single embryo culture?

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

160Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
single embryo culture	Active Comparator	single embryo culture in single drops inside micro-well group culture dish	Other: micro-well group culture dish
group embryo culture	Experimental	group embryo culture in a single drop inside micro-well group culture dish	Other: micro-well group culture dish

Interventions

Name	Type	Description	Arm Group Labels	Other Names
micro-well group culture dish	Other	an embryo culture dish containing nine micro-wells in the middle.	group embryo culture single embryo culture

Measure	Description	Time Frame
Blastocyst development		6 days

Measure	Description	Time Frame
Implantation rate		1 month

Measure	Description	Time Frame
Clinical pregnancy rate		1 month

Eligibility Module

Eligibility Criteria

Inclusion Criteria: female age uner 40, male age under 60 patients undergoing IVF-treatment with oocyte collection after ovarian hyperstimulation having signed the study-specific consent form patient fulfilling clinic's standard criteria for blastocyst culture minimum 5 normally fertilized oocytes at the time of fertilization check

Exclusion Criteria: use of any type of surgically retrieved sperm cells patients undergoing any kind of genetic diagnosis at any developmental stage

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

39 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Elif Güler Ergin, MD	Contact	+90 5327882101		drelifergin@gmail.com

Overall Officials

Name	Affiliation	Role
Elif Güler Ergin, MD	Eurofertil IVF Health Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Eurofertil IVF Health Center	Recruiting	Istanbul			Turkey (Türkiye)

Condition Browse Module

MeSH Terms

ID	Term
D007246	Infertility

Ancestor Terms

ID	Term
D000091662	Genital Diseases
D000091642	Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided