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Cleavage Pattern of Embryos and Oxidative Parameters

Primary Purpose

Infertility

Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
oxidative stress measurement
Sponsored by
Carmel Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Infertility

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Carmel Medical CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Patients

Arm Description

Oxidative stress measurement in cleavage state embryos

Outcomes

Primary Outcome Measures

implantation rate
Implantation rate (positive BHCG)
clinical pregnancy rate
Clinical pregnancy as defined by appearance of gestational sac on ultrasound

Secondary Outcome Measures

Full Information

First Posted
December 26, 2018
Last Updated
February 2, 2020
Sponsor
Carmel Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT03791931
Brief Title
Cleavage Pattern of Embryos and Oxidative Parameters
Official Title
Is Abnormal Cleavage Pattern of Embryos Associated With Different Oxidative Parameters Compared With That of Normally Cleaving Embryos? A Prospective Cohort Study
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Unknown status
Study Start Date
July 7, 2019 (Actual)
Primary Completion Date
January 1, 2021 (Anticipated)
Study Completion Date
April 1, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Carmel Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Patients
Arm Type
Other
Arm Description
Oxidative stress measurement in cleavage state embryos
Intervention Type
Diagnostic Test
Intervention Name(s)
oxidative stress measurement
Intervention Description
oxidative stress measurement
Primary Outcome Measure Information:
Title
implantation rate
Description
Implantation rate (positive BHCG)
Time Frame
1 year
Title
clinical pregnancy rate
Description
Clinical pregnancy as defined by appearance of gestational sac on ultrasound
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zofnat Wiener, MD
Phone
97248250335
Email
wiener_zofnat@clalit.org.il
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zofnat Wiener, MD
Organizational Affiliation
Carmel Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Carmel Medical Center
City
Haifa
ZIP/Postal Code
3436212
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zofnat Wiener, MD
Phone
97248250147

12. IPD Sharing Statement

Plan to Share IPD
No

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Cleavage Pattern of Embryos and Oxidative Parameters

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