Study of Free DNA Content of Embryo Culture Medium as a N... | NCT02480491

Studies
Study of Free DNA Content of Embryo Culture Medium as a Non-Invasive Tool for Embryo Assessment

NCT02480491

Sponsor

Sadat City University

Status

Completed

Last Update Posted

Jun 24, 2015Estimated

Enrollment

100Actual

Phase

Not provided

Conditions

Infertility

Interventions

measuring cell freeDNA

Countries

Not provided

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

Jun 2015

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 2014

Primary Completion Date

Feb 2015Actual

Completion Date

May 2015Actual

First Submitted Date

Jun 20, 2015

First Submission Date that Met QC Criteria

Jun 23, 2015

First Posted Date

Jun 24, 2015Estimated

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

Jun 23, 2015

Last Update Posted Date

Jun 24, 2015Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Azza Awad Abdel Razik Mohamed, Director of Embryology Lab., Ain Shams Univesity, Sadat City UniversityPrincipal Investigator

Lead Sponsor

Sadat City UniversityOTHER

Collaborators

Name	Class
Ain Shams University	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

Study of Cell Free DNA Content of Human Embryo Culture Medium as a Non-Invasive Tool for Embryo Assessment in intra cytoplasmic sperm injection Treatment Cycles.

Detailed Description

The aim of the present study is to determine whether cell free DNA content of the culture medium of the human embryo correlates with the quality and reproductive potential of embryos in ICSI cycles and, thus, to look for a new non invasive tool of assessing embryo quality beside morphological assessment. Determining a rapid, noninvasive method for the assessment of the developmental potential of embryos may be a great achievement

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

Retention

Enrollment

100Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Third day embryos		embryos culture media during third day after fertilization	Other: measuring cell freeDNA
Fifth day embryos		embryos culture media during fifth day after fertilization	Other: measuring cell freeDNA

Interventions

Name	Type	Description	Arm Group Labels	Other Names
measuring cell freeDNA	Other	measuring cell free DNA using PCR	Fifth day embryos Third day embryos

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
correlations between levels of measured cell free DNA and embryo quality.		12 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

third day embryos

Exclusion Criteria:

less than third day embryos

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

ICSI Treatment Cycles females

Sampling Method

Non-Probability Sample

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