Cleavage Pattern of Embryos and Oxidative Parameters

February 2, 2020 updated by: Zofnat Wiener, Carmel Medical Center

Is Abnormal Cleavage Pattern of Embryos Associated With Different Oxidative Parameters Compared With That of Normally Cleaving Embryos? A Prospective Cohort Study

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.

Study Overview

Status

Unknown

Conditions

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.

Study Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

      • Haifa, Israel, 3436212
        • Recruiting
        • Carmel Medical Center
        • Contact:
          • Zofnat Wiener, MD
          • Phone Number: 97248250147

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Patients
Oxidative stress measurement in cleavage state embryos
oxidative stress measurement

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Zofnat Wiener, MD, Carmel Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 7, 2019

Primary Completion (Anticipated)

January 1, 2021

Study Completion (Anticipated)

April 1, 2021

Study Registration Dates

First Submitted

December 26, 2018

First Submitted That Met QC Criteria

January 1, 2019

First Posted (Actual)

January 3, 2019

Study Record Updates

Last Update Posted (Actual)

February 5, 2020

Last Update Submitted That Met QC Criteria

February 2, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CMC 18-0087-CTIL

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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