Comparison Of The Embryoscope Time-Lapse System With Standard Embryo Culture

Infertility Clinical Trial

Official title:

Comparison Of The Embryoscope Time-Lapse System With Standard Embryo Culture at Center for Human Reproduction(CHR):an Open Label Randomized Clinical Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02246309
• Other study ID #: ER08282014-01
• Status: Terminated
• Phase: N/A
• Start date: September 2014
• Est. completion date: December 2015

Study information

• Verified date: December 2015
• Source: Center for Human Reproduction
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

A large number of IVF centers all around the world are converting from standard embryology practice, where embryos are by embryologists manually processed during culture, to so-called "embryoscopes," where embryo culture is 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 pregnancy rates. They also claim that use of this system saves laboratory personnel time. The FDA has so far, therefore, approved for sale at least 2 such systems In the USA.

(i) Our analysis of the published literature has failed to find studies in support of the claim that utilization of such equipment really improves pregnancy rates with IVF; and (ii) Investigators are concerned that CHR's highly adversely selected patient population may demonstrate different utilization outcomes from standard patient populations, especially since this equipment is usually utilized to culture embryos to blastocyst stage (days 5/6), while CHR cultures most patients only to day-3.

Investigators, therefore, contacted the manufacturer of the first FDA approved system, and explained our concerns. The manufacturer agreed to loan us one of their systems for a 4-months long study free of charge (CHR just pays a nominal amount for installation and training costs) but will be financially responsible for supplies.

During these 4 months, CHR will perform an open-label prospective (registered) and randomized clinical trial, in which investigators, based on computerized randomization, will assign all CHR patients (who agree to participate with informed written consent), either to standard embryology or "embryoscope" embryology.

Recruiting approximately 30 patients per month into the study is anticipated, which would give us a population of ~n=60 in each study group.

Patient with excessive numbers of eggs retrieved (>12) will be excluded since the purpose of this study is to investigate the utility of the system in a relatively adversely selected patient population. All other patients will be offered participation.

The study will have as primary end point a time analysis of laboratory manpower, under which the time spent on each patient by embryologist will be recorded and compared and as secondary end point IVF cycle outcome, defined by number of good quality embryos available for transfer, implantation rates and clinical pregnancy rates.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 31
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 48 Years

Eligibility

Inclusion Criteria:

• Patients already planning to undergo in vitro fertilization

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Infertility

Intervention

Device:
• Embryoscope Time Lapse System
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.
• Standard Embryo Culture
Standard embryo culture in a Standard water jacketed carbon dioxide/low oxygen incubator system.

Locations

Country	Name	City	State
United States	Center for Human Reproduction	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Center for Human Reproduction	FertiliTech Inc.

Country where clinical trial is conducted

United States, 

References & 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 an — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Clinical Pregnancy Rate	Existence of Clinical Pregnancy documented by sonogram 4 weeks after embryo transfer	4 weeks
Primary	Personnel Effort	Number of minutes spent by laboratory personnel technical staff in support of each system	Three days
Secondary	Embryo Quality	Number of Grade A best quality of day 3 embryos (based on cell number and degree of fragmentation)	Three Days