Improving Embryogenesis by Adding Growth Factors to In Vi... | NCT02426008

Studies
Improving Embryogenesis by Adding Growth Factors to In Vitro Human Culture Media

NCT02426008

Sponsor

Ibn Sina Hospital

Status

Completed

Last Update Posted

Oct 2, 2018Actual

Enrollment

426Actual

Phase

Not Applicable

Conditions

In Vitro Human Embryo Development

Interventions

Growth Factors and Cytokine adding to embryo culture media
No Intervention

Countries

Egypt

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

Sep 2018

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

May 1, 2015Actual

Primary Completion Date

Mar 2016Actual

Completion Date

Mar 2016Actual

First Submitted Date

Apr 17, 2015

First Submission Date that Met QC Criteria

Apr 21, 2015

First Posted Date

Apr 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

Sep 29, 2018

Last Update Posted Date

Oct 2, 2018Actual

Name	Class
Banon IVF Center Assiut, Egypt	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

The investigators suppose that adding growth factors that had been found in the female tubal fluid and uterus to In Vitro single step culture media for human embryos might improve the the embryogenesis In Vitro and the clinical outcome of the resulting off spring.

Detailed Description

The IVF culture media design and upgrade underwent many ideas during the last 3 decades, we suppose that adding growth factors ( Insulin-like growth factor I, Insulin-like growth factor II, transforming growth factor-beta and epidermal growth factor ) as a promoting growth factors to Lifeglobal culture media might improve embryo development in vitro so we decide to design a trial to compare the embryogenesis by sibling Oocytes of the same patient between to arm of the same culture media and the same culture condition but with one arm with growth factors and the other is traditional one and closely monitor the outcome within the 2 arms and record the results.

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

426Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Culture media with growth factors and Cytokine	Experimental	Growth factors and Cytokine adding to culture media to detect the deference and monitor the embryological outcome.	Other: Growth Factors and Cytokine adding to embryo culture media
In Vitro culture media	Placebo Comparator	culture media to monitor the embryological outcome as control group	Other: No Intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Growth Factors and Cytokine adding to embryo culture media	Other		Culture media with growth factors and Cytokine
No Intervention

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Clinical Pregnancy rate ( % )		3 months

Secondary Outcomes

Measure	Description	Time Frame
ongoing Pregnancy rate ( % )		6 months
rates of blastocyst formation and quality		6 days of culture

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

all patients

Exclusion Criteria:

over 40 years old

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

Not provided

Sampling Method

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D036341	Intercellular Signaling Peptides and Proteins

Ancestor Terms

ID	Term
D010455	Peptides
D000602	Amino Acids, Peptides, and Proteins
D011506	Proteins
D001685	Biological Factors

Browse Leaves

Not provided

Browse Branches

Not provided