NCT02009891

Brief Summary

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).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2012

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

June 1, 2012

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

December 9, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 12, 2013

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2016

Completed
Last Updated

September 25, 2017

Status Verified

September 1, 2017

Enrollment Period

4.3 years

First QC Date

December 9, 2013

Last Update Submit

September 21, 2017

Conditions

Infertility

Keywords

predictive modelin vitro fertilizationelective single embryo transfer

Outcome Measures

Primary Outcomes (1)

  • Clinical pregnancy rate at 8 -10 weeks gestational age

    36 months

Secondary Outcomes (1)

  • Multiple pregnancy rate

    36 months

Study Arms (2)

Control

Control couples who will not use predictive model

Predictive model

Couples who will use predictive model

Eligibility Criteria

Age18 Years - 38 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability 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.

You may qualify if:

  • Under 38 1st or second IVF attempt

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ottawa Fertility Centre

Ottawa, Ontario, K2C3V4, Canada

Location

Related Links

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Study Officials

  • Arthur Leader, MD

    University of Ottawa

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Consultant

Study Record Dates

First Submitted

December 9, 2013

First Posted

December 12, 2013

Study Start

June 1, 2012

Primary Completion

October 1, 2016

Study Completion

October 1, 2016

Last Updated

September 25, 2017

Record last verified: 2017-09

Locations

CA(1)