- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03791931
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
Intervention / Treatment
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
- Name: Zofnat Wiener, MD
- Phone Number: 97248250335
- Email: wiener_zofnat@clalit.org.il
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.
Sponsor
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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