Cleavage Pattern of Embryos and Oxidative Parameters | NCT03791931

Studies
Cleavage Pattern of Embryos and Oxidative Parameters

NCT03791931

Sponsor

Carmel Medical Center

Status

Unknown status

Last Update Posted

Feb 5, 2020Actual

Enrollment

200Estimated

Phase

Not Applicable

Conditions

Infertility

Interventions

oxidative stress measurement

Countries

Israel

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 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 7, 2019Actual

Primary Completion Date

Jan 1, 2021Estimated

Completion Date

Apr 1, 2021Estimated

First Submitted Date

Dec 26, 2018

First Submission Date that Met QC Criteria

Jan 1, 2019

First Posted Date

Jan 3, 2019Actual

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 2, 2020

Last Update Posted Date

Feb 5, 2020Actual

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

To investigate prospectively whether embryos with abnormal cleaving pattern have different oxidative parameters from normally cleaving embryos, and to analyze whether these parameters have an association with demographic, laboratory and clinical parameters including treatment outcome.

Detailed Description

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

200Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Patients	Other	Oxidative stress measurement in cleavage state embryos	Diagnostic Test: oxidative stress measurement

Interventions

Name	Type	Description	Arm Group Labels	Other Names
oxidative stress measurement	Diagnostic Test	oxidative stress measurement	Patients

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
implantation rate	Implantation rate (positive BHCG)	1 year
clinical pregnancy rate	Clinical pregnancy as defined by appearance of gestational sac on ultrasound	1 year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients undergoing IVF for the treatment of infertility

Exclusion Criteria:

Age <18 or >45 years old
Patients with no embryos with direct cleavage

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Zofnat Wiener, MD	Contact	97248250335		wiener_zofnat@clalit.org.il

Overall Officials

Name	Affiliation	Role
Zofnat Wiener, MD	Carmel Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Carmel Medical Center	Recruiting	Haifa		3436212	Israel

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

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