Clinical trial NCT02246309: Comparison Of The Embryoscope Time-Lapse System With Standard Embryo Culture
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Infertility
Keywords: Infertility
Embryo Culture
Laboratory Technique
Lead sponsor: Center for Human Reproduction
Sponsor class: OTHER
Collaborators: name: FertiliTech Inc.
First posted: 2014-09-22
Enrollment: 31
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 48
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

* Patients already planning to undergo in vitro fertilization

Exclusion Criteria:

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

Primary outcomes:
measure: Personnel Effort
timeFrame: Three days
Secondary outcomes:
measure: Embryo Quality
timeFrame: Three Days
Other outcomes:
measure: Clinical Pregnancy Rate
timeFrame: 4 weeks
Locations:
city: New York
country: United States
facility: Center for Human Reproduction
state: New York
Study officials:
affiliation: Center for Human Reproduction
name: David Barad, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.