Supplementing Intracytoplasmic Sperm Injection Handling M... | NCT03677492

Studies
Supplementing Intracytoplasmic Sperm Injection Handling Medium With Cytochalasin D ( ICSI-CD)

NCT03677492

Sponsor

Ibn Sina Hospital

Status

Completed

Last Update Posted

May 7, 2019Actual

Enrollment

300Actual

Phase

Not Applicable

Conditions

Infertility

Interventions

Medium Supplemented with Cytochalasin D

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

May 2019

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

Sep 25, 2018Actual

Primary Completion Date

Apr 25, 2019Actual

Completion Date

Apr 30, 2019Actual

First Submitted Date

Sep 17, 2018

First Submission Date that Met QC Criteria

Sep 17, 2018

First Posted Date

Sep 19, 2018Actual

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

May 5, 2019

Last Update Posted Date

May 7, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

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

Vienna Consensus has identified 10% damage rate after ICSI as a competency value. Despite the highest quality embryologists doing ICSI, degeneration sometimes occurs due to oocyte factors such as the fragile membrane, etc. Cytochalasin D serves to facilitate spindle or pronuclear transfer procedures helping to reduce the damage rate with no harm reported. Using Cytochalasin D during ICSI could serve to rescue some oocytes from the degeneration allowing for more chances of viable zygotes.

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

300Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Handling Medium Supplemented with Cytochalasin D	Experimental		Other: Medium Supplemented with Cytochalasin D
Handling Medium as it is.	No Intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Medium Supplemented with Cytochalasin D	Other	A medium with in-house supplementation of Cytochalasin D to decrease oocyte degeneration after ICSI and improve the survival rate	Handling Medium Supplemented with Cytochalasin D

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Oocyte survival rate		6 days of culture

Secondary Outcomes

Measure	Description	Time Frame
Fertilization rate		6 days of culture
Blastocyst formation rate		6 days of culture
Embryo utilization rate

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

ICSI indicated participants

Exclusion Criteria:

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

42 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 Assiut		Asyut			Egypt
IbnSina IVF Center, IbnSina Hospital

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
D015638	Cytochalasin D

Ancestor Terms

ID	Term
D003572	Cytochalasins
D007211	Indoles
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring

Browse Leaves

Not provided

Browse Branches

Not provided