NCT02246309

Brief Summary

"Embryoscopes," allow for embryo culture to be performed in an automated incubation system under time lapse photography. Manufacturers of these systems (and investigators who have used these systems) claim that the availability of 24-hour time-lapse photographic control improves embryo selection and, therefore, IVF (in vtro fertilization) pregnancy rates. They also claim that use of this system saves laboratory personnel time. This study will randomize approximately 120 patients (60 in each arm) to standard embryo culture or to culture in an Embryoscope. The primary endpoint will be a comparison of time spent by the laboratory personnel with each system. Secondary endpoints will be IVF outcomes.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
31

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2014

Geographic Reach
1 country

1 active site

Status
terminated

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

September 1, 2014

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

September 18, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 22, 2014

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
2.5 years until next milestone

Results Posted

Study results publicly available

May 17, 2018

Completed
Last Updated

May 17, 2018

Status Verified

December 1, 2015

Enrollment Period

1.2 years

First QC Date

September 18, 2014

Results QC Date

July 19, 2017

Last Update Submit

April 18, 2018

Conditions

Infertility

Keywords

InfertilityEmbryo CultureLaboratory Technique

Outcome Measures

Primary Outcomes (1)

  • Personnel Effort

    Number of minutes spent by laboratory personnel technical staff in support of each system

    Three days

Secondary Outcomes (1)

  • Embryo Quality

    Three Days

Other Outcomes (1)

  • Clinical Pregnancy Rate

    4 weeks

Study Arms (2)

Embryoscope Time Lapse System

EXPERIMENTAL

All embryos from patients randomized to this arm will be cultured in the Embryoscope culture system from the time of insemination until the time of transfer on day 3. All staff interaction with the embryos or with maintenance or supervision of the system will be timed.

Device: Embryoscope Time Lapse System

Standard Embryo Culture

ACTIVE COMPARATOR

All embryos from patients randomized to this arm will be cultured in the standard embryo culture system from the time of insemination until the time of transfer on day 3. All staff interaction with the embryos or with maintenance or supervision of the system will be timed.

Device: Standard Embryo Culture

Interventions

Embryoscope Time Lapse SystemDEVICE

The EmbryoScope® time-lapse system is a unique platform facilitating improved IVF treatment, flexible work routines and effective communication, through comprehensive documentation of embryo development and evolving improvements in selection.

Embryoscope Time Lapse System
Standard Embryo CultureDEVICE

Standard embryo culture in a Standard water jacketed carbon dioxide/low oxygen incubator system.

Also known as: Standard water jacketed incubator system
Standard Embryo Culture

Eligibility Criteria

Age18 Years - 48 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Patients already planning to undergo in vitro fertilization

You may not qualify if:

  • Patients with more than 12 oocytes will be excluded from this trial

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Center for Human Reproduction

New York, New York, 10021, United States

Location

Related Publications (1)

  • Wu YG, Lazzaroni-Tealdi E, Wang Q, Zhang L, Barad DH, Kushnir VA, Darmon SK, Albertini DF, Gleicher N. Different effectiveness of closed embryo culture system with time-lapse imaging (EmbryoScope(TM)) in comparison to standard manual embryology in good and poor prognosis patients: a prospectively randomized pilot study. Reprod Biol Endocrinol. 2016 Aug 24;14(1):49. doi: 10.1186/s12958-016-0181-x.

    PMID: 27553622RESULT

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Results Point of Contact

Title
Dr. David Barad, Director of Clinical Research
Organization
Center for Human Reproduction
dbarad@theCHR.com
2129944400

Study Officials

  • David Barad, MD

    Center for Human Reproduction

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 18, 2014

First Posted

September 22, 2014

Study Start

September 1, 2014

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

May 17, 2018

Results First Posted

May 17, 2018

Record last verified: 2015-12

Locations

US(1)