Use of Predictive Model to Assist Patients Having an Embryo Transfer After IVF

September 21, 2017 updated by: Dr. Arthur Leader, Ottawa Fertility Centre

The Application of a Validated Patient and Clinic Specific Predictive Model to Reduce the Incidence of Multiple Births Resulting From Fresh In Vitro Fertilization Cycles

To determine in women undergoing IVF who are at high risk of multiple births (>35%), as calculated by the application of a predictive model - IVFsingleTM, if single embryo transfer will lead to both comparable clinical pregnancy rate (CPR) and other secondary outcomes such as live birth rate (LBR) and cumulative live birth rate (cLBR) in comparison to DET while reducing the incidence of multiple births (a secondary outcome measure).

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

200

Contacts and Locations

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

Study Locations

  • Canada
    • Ontario
      • Ottawa, Ontario, Canada, K2C3V4
        • Ottawa fertility centre

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 38 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

Women under age 38 undergoing 1st or 2nd IVF treatment who havae not had previous IVF pregancy nor cancelled IVF cycle for poor response.

Description

Inclusion Criteria:

Under 38 1st or second IVF attempt

-

Exclusion Criteria:

Over 37 years old donor egg third or greater IVF attempt cancellation in previous cycle for poor response successful pregnancy with IVF -

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

  • Observational Models: Other
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Control
Control couples who will not use predictive model
Predictive model
Couples who will use predictive model

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Clinical pregnancy rate at 8 -10 weeks gestational age
Time Frame: 36 months
36 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Multiple pregnancy rate
Time Frame: 36 months
36 months

Collaborators and Investigators

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

Sponsor

Ottawa Fertility Centre

Investigators

  • Principal Investigator: Arthur Leader, MD, University of Ottawa

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

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

June 1, 2012

Primary Completion (Actual)

October 1, 2016

Study Completion (Actual)

October 1, 2016

Study Registration Dates

First Submitted

December 9, 2013

First Submitted That Met QC Criteria

December 11, 2013

First Posted (Estimate)

December 12, 2013

Study Record Updates

Last Update Posted (Actual)

September 25, 2017

Last Update Submitted That Met QC Criteria

September 21, 2017

Last Verified

September 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 100OFC

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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