Novel Approach for Embryo Transfer Medium by Adding Cytok... | NCT02422134

Studies
Novel Approach for Embryo Transfer Medium by Adding Cytokine to Hyaluronan Enriched Embryo Transfer Medium (Embryo Glue)

NCT02422134

Sponsor

Ibn Sina Hospital

Status

Completed

Last Update Posted

Jun 29, 2016Estimated

Enrollment

400Actual

Phase

Not Applicable

Conditions

Infertility

Interventions

Cytokine group

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

Jun 2016

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

Jun 2014

Primary Completion Date

Jun 2015Actual

Completion Date

Jun 2015Actual

First Submitted Date

Apr 16, 2015

First Submission Date that Met QC Criteria

Apr 20, 2015

First Posted Date

Apr 21, 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 28, 2016

Last Update Posted Date

Jun 29, 2016Estimated

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

It was proven that the Cytokine granulocyte-Macrophage clony stimulating factor had been found naturally in reproductive tract so our target is to test its effect if added to embryo transfer medium.

Detailed Description

The IVF embryo transfer media design and upgrade underwent many ideas during the last 3 decades, we suppose that adding Cytokine GM-CSF as an endometrial modifier to already proven successful medium hyaluronan enriched medium to test the efficacy ipon pregnancy and implantation rate in vitro so we decide to design a trial to compare the clinical outcome by sibling embryo to be transferred into 2 groups and the same culture condition but with one arm with Cytokine 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

400Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Cytokine plus Hyalurinan embryo transfer arm	Active Comparator	To monitor the pregnancy and implantation of the patients in this arm after adding Cytokine to the embryo transfer medium.	Other: Cytokine group
Hyalurinan embryo transfer group	No Intervention	To transfer the embryos using a Hyaluronan enriched medium only

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Cytokine group	Other	Testing the efficacy of adding Cytokine to embryo transfer medium	Cytokine plus Hyalurinan embryo transfer arm

Measure	Description	Time Frame
Pregnancy rate ( % )		9 months

Measure	Description	Time Frame
Implantation rate ( % )		9 months

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

all patients

Exclusion Criteria:

above 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

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Banon IVF center		Asyut			Egypt
Ibnsina IVF center

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