Blastocyst Culture Using Time-lapse in Good Prognosis IVF... | NCT01773603

Studies
Blastocyst Culture Using Time-lapse in Good Prognosis IVF Patients and Elective Single Embryo Transfer

NCT01773603

Sponsor

Dr. Murat Çetinkaya

Status

Terminated

Last Update Posted

Jan 23, 2013Estimated

Enrollment

64Actual

Phase

Not Applicable

Conditions

Infertility

Interventions

Embryoscope

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

ID	Type	Description	Link
IMH2013-1	Other Identifier	Sisli Memorial Hospital

Status Module

Record Verification Date

Jan 2013

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

No statistical difference observed for outcomes.

Expanded Access Info

Start Date

Dec 2011

Primary Completion Date

Jun 2012Actual

Completion Date

Jul 2012Actual

First Submitted Date

Jan 18, 2013

First Submission Date that Met QC Criteria

Jan 18, 2013

First Posted Date

Jan 23, 2013Estimated

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 18, 2013

Last Update Posted Date

Jan 23, 2013Estimated

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

Choosing the best embryo for transfer has become the major challenge in in vitro fertilization (IVF). Morphology alone is obviously not enough and time-lapse incubation has added embryo development kinetics as another selection criterion.

This study was designed to select for the top blastocyst to be replaced, while increasing the pregnancy chance, with the local legislation regulating the number of embryos to be transferred and to establish a morphokinetic standard to be used in our clinical setting.

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

64Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Conventional incubation	No Intervention	Five-day embryo culture in conventional incubators
Embryoscope	Active Comparator	Five-day embryo culture in embryoscope which is an incubator with a built-in camera	Device: Embryoscope

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Embryoscope	Device	Five-day embryo culture in embryoscope which is an incubator with a built-in camera	Embryoscope

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Blastocyst formation rate		5th day of embryonic development

Secondary Outcomes

Measure	Description	Time Frame
Clinical pregnancy rate	Clinical pregnancy was defined as the presence of a gestational sac detected on ultrasound 3 weeks after the first βhCG test, which was performed 14 days after oocyte retrieval.	7th week of pregnancy

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

patients in their first or second ART treatment cycle
no recurrent spontaneous abortions
age<35 years
BMI<28 kg/m2
≥8 oocytes retrieved

Exclusion Criteria:

severe endometriosis
polycystic ovary syndrome
hydrosalpynx
uterine pathology
severe male factor (presenting less than 5 million motile sperm cells in total in the ejaculate)
very severe morphological sperm defects (mainly globozoospermic or macrocephalic samples)

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

35 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Semra Kahraman, MD, Prof	Sisli Memorial Hospital	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Sisli Memorial Hospital		Istanbul		34385	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

Intervention Browse Module

MeSH Terms

ID	Term
D020669	Fetoscopes

Ancestor Terms

ID	Term
D019723	Endoscopes
D019719	Diagnostic Equipment
D004864	Equipment and Supplies
D013523	Surgical Equipment

Browse Leaves

Not provided

Browse Branches

Not provided