Genomic DNA in Human Blastocoele Fluid | NCT01780415

Studies
Genomic DNA in Human Blastocoele Fluid

NCT01780415

Sponsor

Cervesi Hospital, Cattolica, Italy

Status

Unknown status

Last Update Posted

Feb 9, 2021Actual

Enrollment

35Actual

Phase

Not provided

Conditions

Chromosomal Aneuploidies
Single Gene Desease

Interventions

blastocoele aspiration

Countries

Italy

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

Feb 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2013

Primary Completion Date

Dec 2021Estimated

Completion Date

Jan 2022Estimated

First Submitted Date

Jan 28, 2013

First Submission Date that Met QC Criteria

Jan 30, 2013

First Posted Date

Jan 31, 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

Feb 8, 2021

Last Update Posted Date

Feb 9, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Palini Simone, Senior Clinical Embryologist, Cervesi Hospital, Cattolica, ItalyPrincipal Investigator

Lead Sponsor

Cervesi Hospital, Cattolica, ItalyOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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 objective will focus on the characterization of DNA fragments present in Blastocoele fluid, and the evaluation of these fragments as potential target for Preimplantation Genetic Diagnosis. To reach this goal, real-time PCR, Whole Genome Amplification techniques and -subsequently- Next Generation Sequencing and aCGH approaches will be used.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

35Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Bastovit		all the patients that have supernumerary embryos to vitrify at blastocyst stage	Other: blastocoele aspiration

Interventions

Name	Type	Description	Arm Group Labels	Other Names
blastocoele aspiration	Other		Bastovit

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of samples with DNA in blastocoele Fluid	the presence of DNA will be evaluated through rtPCR	6 month

Secondary Outcomes

Measure	Description	Time Frame
Number of euploid samples	Array CGH	8 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

IVF patient with supernumerary embryos to vitrify at blastocyst stage

Exclusion Criteria:

IVF patient without blastocyst formation

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

40 Years

Standard Ages

Adult

Study Population

IVF patient with supernumerary embryos to vitrify at blastocyst stage

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Cervesi Hospital IVF Unit		Cattolica	Rimini	47841	Italy