NCT03791931

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2019

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 26, 2018

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 3, 2019

Completed
6 months until next milestone

Study Start

First participant enrolled

July 7, 2019

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2021

Completed
Last Updated

February 5, 2020

Status Verified

February 1, 2020

Enrollment Period

1.5 years

First QC Date

December 26, 2018

Last Update Submit

February 2, 2020

Conditions

Infertility

Outcome Measures

Primary Outcomes (2)

  • implantation rate

    Implantation rate (positive BHCG)

    1 year

  • clinical pregnancy rate

    Clinical pregnancy as defined by appearance of gestational sac on ultrasound

    1 year

Study Arms (1)

Patients

OTHER

Oxidative stress measurement in cleavage state embryos

Diagnostic Test: oxidative stress measurement

Interventions

oxidative stress measurementDIAGNOSTIC_TEST

oxidative stress measurement

Patients

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Patients undergoing IVF for the treatment of infertility

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Carmel Medical Center

Haifa, 3436212, Israel

RECRUITING

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Study Officials

  • Zofnat Wiener, MD

    Carmel Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Zofnat Wiener, MD

CONTACT

97248250335wiener_zofnat@clalit.org.il

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

December 26, 2018

First Posted

January 3, 2019

Study Start

July 7, 2019

Primary Completion

January 1, 2021

Study Completion

April 1, 2021

Last Updated

February 5, 2020

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will not share

Locations

IL(1)